Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

Continuing the 510(k) premarket notifications list, 1000 records per page.

  1. K073513MERITS E700 PORCE LIFT
  2. K922557ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT
  3. K130925AUTOMATIC BLOOD PRESSURE MONITOR
  4. K923710OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED
  5. K262153Pivot Insulin Delivery System
  6. K024066INFINION SOFTWARE FEATURES
  7. K092349CLEARVIEW EXACT II INFLUENZA A & B TEST
  8. K802708SYSTEM, ECHO, PULSED ULTRASONIC DIAG.
  9. K070402MODIFICATION TO POLAR CARE 500
  10. K854878H40 BASE METAL ALLOY
  11. K912531IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
  12. K870272MODEL 6110C OTOPHOR
  13. K912416ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM
  14. K031900HANDMASTER
  15. K161482EndoChoice Water Bottle Cap Irrigation System
  16. K864667PENOX HOSPITAL BED
  17. K973492DENTALVIEW PERIOVIEW SYSTEM
  18. K940486DIGENE DCR-1 LUMINOMETER
  19. K812688QI 1150-1T INFUSION T
  20. K780097QUALITY CONTROL SYSTEM, SPECTRA
  21. K961457SUBLIMINATOR
  22. K760002KNEE AID
  23. K062064RIVA BOND LC
  24. K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A…
  25. K873577GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
  26. K845029SURGICAL POWER MAGNET
  27. K930259TRACTION TABLE MODEL #825-200
  28. K970312CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
  29. K020950SPECTRAL'S 2 IN 1 (TNI-MYO)
  30. K083101PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
  31. K243081Green X 21 (PHT-90CHO)
  32. K842627C-SECTION TRAY
  33. K040275LYPHOCHEK HEMOSTASIS CONTROL
  34. K063663DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND…
  35. K994343BACT/ALERT SV
  36. K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
  37. K222471IRRAflow Active Fluid Exchange System (AFES)
  38. K960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS
  39. K131625ANYSCAN-S SPECT IMAGING SYSTEM
  40. K992178BALLOON FOR ULTRASONIC ENDOSCOPES
  41. K051962ULTRA HDL
  42. K885159MENSOR MAGNASKIRT
  43. K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
  44. K932379ALL-BOND(R) JR.
  45. K170112IMD's Lumbar Puncture Needle
  46. K905573XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
  47. K961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
  48. K803111ERECTAID
  49. K112603ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
  50. K852809JAGUAR
  51. K012277PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
  52. K863062CHOLESTEROL-E (TOTAL)
  53. K924118PROPAK
  54. K152521Seal Rite Non-Rebreathing Valve
  55. K811075BALANCE ARTICULATOR
  56. K843882TRENDS LANCET
  57. K102161BLUE SAIL INNOVATION
  58. K990160MICROTAC-BONE ANCHOR SYSTEM
  59. K823328HARRIS HEMATOXYLIN
  60. K892703PATIENT EXAMINATION GLOVES (LATEX)
  61. K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…
  62. K200574EksoNR
  63. K981289N-ASSAY L T-BIL
  64. K822666ANTISERUM TO HUMAN KAPPA
  65. K912106ARTHROSCOPY TRAY
  66. K020257DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE…
  67. K901871DEGUFILL (R) ADHESIVE
  68. K171450Glooko Mobile Insulin Dosing System
  69. K933721EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM
  70. K920994HOOD NASAL SEPTAL BUTTON
  71. K952922BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL
  72. K953483SIMS BLUE LINE ENDOBRONCHIAL TUBE
  73. K102293CALIBER SPACER
  74. K870084RD 140 SURGICAL BENDER
  75. K812050KALLESTAD ANTISERA TO GENTAMICIN
  76. K070737XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
  77. K250862EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE…
  78. K242301Socrates 38 Catheter
  79. K8406862U PENICILLIN DISC
  80. K090238SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
  81. K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG
  82. K060755ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
  83. K242251Litho 60; Litho 100; Litho 150
  84. K901803SYRINGE NEEDLE INTRODUCER
  85. K010438MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50…
  86. K243321Endoscopic Video Image Processor (RP-IPD-V1000F)
  87. K780367RIA SYS. FOR HUMAN LUTEINIZING HORMONE
  88. K953319SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM
  89. K232373Progrip™ Self-Gripping Polypropylene Mesh
  90. K930763FIGLEAF SHIELD
  91. K223590Access Folate Assay
  92. K892911SITE PERISTALTIC CASSETTE
  93. K134015M-PM-DISC
  94. K002819NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
  95. K983886POCKIT HSV 2 RAPID TEST
  96. K133786DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH…
  97. K882158MODIFIED TORAY FILTRYZER DIALYZERS
  98. K250282Persona C HR
  99. K223550DMX
  100. K901759COBAS-FP REAGENTS FOR VANCOMYCIN
  101. K113320NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT…
  102. K790705ANTISERUM TO HUMAN IGM
  103. K915822MULTIPLE DRESSING, STERILE NONADDHERENT PADS
  104. K991553SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
  105. K203029Auxilock Titanium Interference Screw
  106. K926397FAST SPIN ECHO MEASURING FUNCTION
  107. K252730Fule Spinal Fixation System
  108. K020720OSSIFORM
  109. K171206D'Vill Introducer
  110. K893991HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
  111. K941935LP-12 LAPAROSCOPIC PROBE
  112. K070392MOSAIC LASER SYSTEM
  113. K061102PRIMA ANAESTHESIA MACHINE
  114. K860437PARTIAL DENTURE ALLOY
  115. K953645OLYMPIC PASTEURMATIC SYSTEM
  116. K933053ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
  117. K193620OptoMonitor 3
  118. K973508PYLORI DETECT IGG
  119. K933571RADIAS FOLATE ENZYME IMMUNOASSAY
  120. K992731E.CAM COMPUTER
  121. K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
  122. K860415BIOTIS SIMMON CITRATE AGAR
  123. K163358Introcan Safety 3 Closed IV Catheter
  124. K123198LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL…
  125. K023518ECAT LSO PET/CT 16
  126. K925566HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300
  127. K070641ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
  128. K011909ULTRA-THIN SDS BALLOON DILATATION CATHETER
  129. K963083LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
  130. K223476V-PRO maX 2 Low Temperature Sterilization System
  131. K830843BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
  132. K023996ALOKA SSD-3500 ULTRASOUND SYSTEM
  133. K771313CHOLESTEROL REAGENT
  134. K882427CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
  135. K233238Air Pressure Therapy System (Model:VU-IPC4M)
  136. K830154COLLES FRACTURE FRAME
  137. K933600NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
  138. K910667STERI-STAT REUSABLE SYRINGE
  139. K9432591085 ULTIMATE E PLETHYSMOGRAPH
  140. K872172IMMUBEAD THYROID UPTAKE
  141. K812726KERMATH THERAPY SIMULATOR
  142. K163308SMARTO
  143. K960264CONMED EKG STRIPPER
  144. K081597MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
  145. K813286PRE-PACK TENS
  146. K874220OCS 100 (OCULAR COMPARATOR SYSTEM)
  147. K051054VISULIZE FACTOR IX ANTIGEN KIT
  148. K934473LACTOFERRIN MICROASSAY SYSTEM
  149. K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth…
  150. K073271ORTHOGON
  151. K961900TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
  152. K922833QUANTA LITE RNP ELISA
  153. K123326SHERPA PAK CARDIAC TRANSPORT SYSTEM
  154. K827455SONOLINE 3000
  155. K904980DPX-L AND DPX-ALPHA, MODIFICATION
  156. K230362Planar LED mate
  157. K922426SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM
  158. K010199PJUR EROS WATER FORMULATION
  159. K220723Hand Trauma Screw System
  160. K914254HOMECLINIC ONE STEP PREGNANCY TEST
  161. K980575SITESEER ANGIOGRAPHIC CATHETER
  162. K931065LAPAROVIEW
  163. K000480ACTIVE ELECTRODE MONITORING SYSTEM
  164. K950566DECOMAT 4656
  165. K000885DRX HBA1C - FOR PRESCRIPTION HOME USE
  166. K932557HYPERINFLATION SYSTEM
  167. K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti…
  168. K181866MotoCLIP/HiMAX Step Staple Implant System
  169. K812083BILE DISK
  170. K203609Intravascular Administration Sets
  171. K913566ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM
  172. K881848MODIFIED MODEL 2100 ND:YAG LASER
  173. K210244Disposable Medical Face Mask
  174. K101551PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
  175. K142228Heated Eye Pad
  176. K121493ASCEND SHOULDER SYSTEM
  177. K841066SGOT-UV REAGENT SET
  178. K170604FilmArray Respiratory Panel 2 (RP2)
  179. K173553LUCAS 3 Chest Compression System
  180. K063565QUANTA LITE SS-A 52 ELISA
  181. K972297AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
  182. K050682LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
  183. K823428KELLY INFLATABLE T DRAIN
  184. K884365MULTIFLOW(TM) 60 KIT
  185. K792246MEDTRONIC MODEL 9408 TELETRACE TRANSMIT
  186. BK010017Blood Establishment Computer Software and Accessories
  187. K083039VERITAS COLLAGEN MATRIX (DRY)
  188. K0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
  189. K894409CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
  190. K935946POWDER FREE LATEX EXAMINATION GLOVES
  191. K130451NEUROQ 3.6
  192. K910897PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X
  193. K922972MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
  194. K142385Whisper Pump System
  195. K192088GOLNIT Non-aborbable PTFE Surgical Suture
  196. K152882Propeller System
  197. K921058DISPOSABLE ISOLATION GOWN
  198. K935077CATH-SEAL
  199. K892106STERILE EXAM GLOVES
  200. K060894BIFIX QM
  201. K935088POWDER FREE GLOVES
  202. K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
  203. K863099ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
  204. K833525CEMAX-1000
  205. K902519EYE SPY SUNGLASSES
  206. K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
  207. K802728125I-TESTOSTERONE TEST SET
  208. K232384Videa Dental Assist
  209. K821252HOFFMAN UNIVERSAL FOOT SUPPORT
  210. K190056KOWA VK-2s
  211. K061234GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
  212. K870460DORROS(TM) SMALL VESSEL PTA CATHETER
  213. K855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
  214. K895373HEMATOLOGY CONTROL
  215. K133796NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS…
  216. K110518IBAG
  217. K872301DENTOCULT-SM CULTURE-PADDLE
  218. K873519PARAMAX CALCIUM REAGENT
  219. K902327EMBOLECTOMY CATHETER
  220. K202330Impella XR Sheath Set
  221. K843683MODULAR FIBERSCOPE SYSTEM
  222. K161017True HD 3MOS Camera System
  223. K930152ARTHREX TIBIAL TUNNEL CANNULA
  224. K050833ELECTRODE JUNCTION BOX, MODEL JE-921A
  225. K992577PHOTON RADIOSURGERY SYSTEM (PRS)
  226. K882325UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
  227. K060859COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
  228. K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
  229. K033059HERPES GROUP IGG
  230. K892000FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE
  231. K964214STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
  232. K913973INFRARED HEAT LAMPS & MASSAGER MODEL NH-213
  233. K001567ADVANTAGE THC TEST
  234. K143256SMR Modular Glenoid
  235. K121329AIXPLORER
  236. K240235OmniTrans Transport System
  237. K011182MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
  238. K210627Breezeway II
  239. K860353SYRINGE INFUSION PUMP
  240. K253133Wrist Blood Pressure Monitor (BPM-W1VL)
  241. K802661LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
  242. K822206TOTAL IGE DISCS
  243. K972635ULTRACELL SUCTION SPONGE
  244. K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software System
  245. K202612Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint…
  246. K912996MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
  247. K960144G.E. STERILE CT BIOPSY TRAY
  248. K781147EPILATOR, EASE-MULTI-MODE
  249. K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
  250. K081547BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
  251. K962798AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
  252. K861083OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
  253. K820792#19041-150X15MM MUELLER HINTON
  254. K920675DUODERM SUSTAINED COMPRESSION BANDAGE
  255. K241267Hidroxa SE30
  256. K974844OUTLOOK SYSTEM ENHANCEMENT PACKAGE
  257. K812723PEARCE CORNEAL TREPHINE
  258. K120107SCKOONCUP
  259. K944326PHILIPS TOMOSCAN SR5000
  260. K984623MAXIM REMOVABLE MOLDED POLY TIBIA
  261. K944553PRESSURE SENSING SCOPE SHEATH SYSTEM
  262. K894180ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
  263. K122509VERTIFLEX SPINOUS PROCESS FIXATION PLATE
  264. K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…
  265. K093632INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
  266. K863100CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
  267. K130895REUNION RSA SHOULDER SYSTEM
  268. K852088SYSTEM 1085 BODY PLETHYSMOGRAPH
  269. K070665LITHOSKOP
  270. K834318BRUCELLA W/H & K
  271. K172928Portable X-ray System
  272. K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
  273. K760790MICRO-ID
  274. K830490MODEL 50-01-27
  275. K884151MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.
  276. K972211MULTIDOS, QC6PLUS
  277. K013523CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
  278. K840070EGG YOLK AGAR PLATE
  279. K092164TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
  280. K031538ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
  281. K071476SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
  282. K092782INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C…
  283. K190680FAVO S-TLIF
  284. K780109TILL-U=TEST
  285. K170940Rickettsia Real-time PCR Assay
  286. K000433PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
  287. K830198PEDIATRIC EXTEN. SET FOR SECOND-DRUG
  288. K182593KET-1 Blood Ketone Monitoring System
  289. K854630CHURCHILL-HS SUSPENDED NON-VENTED IV SET
  290. K031958MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
  291. K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive…
  292. K791698CDC ANAEROBIC SHEEP BLOOD AGAR (BA)
  293. K952363OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
  294. K970888IOTEC TROCAR AND FLEXIBLE CANNULA
  295. K091243ORTHOLOC ANKLE PLATING SYSTEM (APS)
  296. K032173FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
  297. K895706TUBING ORGANIZER
  298. K140750SHILLA GROWTH GUIDANCE SYSTEM
  299. K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External…
  300. K941932SPLASH MASK
  301. K192527Rochal Antimicrobial Wound Gel
  302. K831294SOLARCRY/TEMPORARY CROWN & BRIDGE MAT
  303. K963400NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
  304. K250384IPL400
  305. K760691THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L
  306. K063773VOLUMETRIC TOMOGRAPHY
  307. K172312eego amplifiers
  308. K770143TQC CALIBRATION REFERENCE FOR PLATELETS
  309. K914178CORRECTED-V.P.S.
  310. K830800C-LOOPS
  311. K953764LMT BONE ANCHOR
  312. K041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
  313. K880111CYSTINE TRYPTIC MEDIUM W/SUCROSE
  314. K063794MODIFICATION TO EASYSPINE SYSTEM
  315. K801424ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
  316. K894682USCI UNCOATED GUIDING CATHETERS
  317. K181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily…
  318. K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH…
  319. K900755DIGITAL CUFF PV GAUGE
  320. K944567COWBOY X
  321. K894668MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
  322. K251316Mazor X System / Mazor X Stealth Edition
  323. K202764Ortho Solutions Plating System
  324. K964593DIASCOPE TRAVELLER PLUS (4053)
  325. K052704MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
  326. K872759AQUATULLE FINE MESH NON-ADHERING DRESSING
  327. K812660TERUMO HOLLOW FIBER OXYGENATOR
  328. K946116URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD
  329. K231126Eblator Device
  330. K882174MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE
  331. K892345SLT CONTACT LASER SYSTEMS (NEUROSURGERY)
  332. K934330TRANSGROW
  333. K222605iFuse TORQ® Implant System
  334. K022207AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
  335. K011286POWDER-FREE NITRILE EXAM GLOVE, BLUE
  336. K003182ORTHOGENESIS LPS SYSTEM
  337. K221516ARTIS icono (Ceiling Configuration)
  338. K014091STRYKER PAINPUMP
  339. K210512LUMINELLE DTx System
  340. K895666BUN (KINETIC)
  341. K870119FIBRE OPTIC STRIP CHART RECORDER
  342. K813357CAULK OPAQUER
  343. K896058GRASPING FORCEPS
  344. K202935Syntec Femoral Nail Extended System
  345. K910891PVC VINYL GLOVE
  346. K014223MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
  347. K894240NEOS 02
  348. K140276CD HORIZON SPINAL SYSTEM
  349. K905623CK-MB IMMUNOASSAY CONTROL
  350. K834366SURGICAL INSTRUMENTS & ACCESSORIES
  351. K001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
  352. K881105CULTURE COLLECTION DEVICE
  353. K051933EXPASYL POWER APPLICATOR
  354. K881661IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT
  355. K951399R&D BATTERIES PART NOS. 5041 & 5655
  356. K031615SLED CURING LIGHT SYSTEM
  357. K902611I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
  358. K863820DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
  359. K946256SUNGLASSES
  360. K840501ACCULAB SUPPLIES CHEMICAL ANALYZERS
  361. K904488KALTOSTAT WOUND DRESSING
  362. K101342OSIRIX MD
  363. K970953E-TYPE SPEED REDUCER CONTRA ANGLE
  364. K222766Disposable Extension Set
  365. K953444MCI OPTONIX ECONOMY CASSETTE
  366. K002419SURGICAL DRAPES
  367. K912324NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
  368. K153779Abutment for Bridges
  369. K864063ORION 3001, LASER PHOTOCOAGULATOR
  370. K032221ADEPT 1064/755 LASER
  371. K941557DISPOSABLE LATEX EXAM GLOVES
  372. K122584HEMOSIL READIPLAS TIN
  373. K012868MICROMEDICS FIBRIJET AEROSOL APPLICATOR
  374. K963133PS-UNIT CASSETTE/SERUM HCG
  375. K031557CARDIOVIT AT-102
  376. K173964OVOMotion Shoulder Arthroplasty System
  377. K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…
  378. K955822REMOVABLE HERBST APPLIANCE
  379. K821521STABILOR NF
  380. K860257DIRECT BILIRUBIN
  381. K923875SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS
  382. K233657NAEOTOM Alpha
  383. K151683SleepWeaver Advance Pediatric Nasal CPAP Mask
  384. K942967AUTO SUTURE SPINAL CURETTE
  385. K844382VANCOMYCIN 5MCG DIFFERENTIAL DISK
  386. K093409POWERPUMP ARTHROSCOPY SYSTEM
  387. BK160017Test, Qualitative, for HLA, Non-Diagnostic
  388. K881506MAMEX DC MAG MG12
  389. K941294SHARP II LOW PROFILE HEARING AID
  390. K983381VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
  391. K813557AUDITORY STIMULATOR
  392. K861081DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH
  393. K772389DANDY HEMOSTATIC FORCEPS
  394. K874355OPACITY LENSMETER 701
  395. K870190DISPOSABLE SYRINGE W/O NEEDLE
  396. K013088ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON…
  397. K904729BLOM-SINGER SHOWER GUARD
  398. K955903SELFCARE EARLY PREGNANCY TEST
  399. K222655OtoSight Middle Ear Scope
  400. K880232NH REPLACEMENT GASTROSTOMY KIT
  401. K083071VERTEX RECONSTRUCTION SYSTEM
  402. K890575ACCUTHERM PTS-200
  403. K822448SCISSORS, VARIOUS
  404. K041734AMBU DISPOSABLE ECG ELECTRODE
  405. K241278ASEPT® Glide Peritoneal Drainage System
  406. K910721BIOTROL PROTEIN MULTILEVEL STANDARDS
  407. K863382CANNON NASAL SPLINT
  408. K904947PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
  409. K202584iSleeve Introducer Set
  410. K920439OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
  411. K910772PROPAQ 102, 104 AND 106
  412. K894978BACTERIAL FILTER
  413. K112278ASCENSION NUGRIP CMC IMPLANT
  414. K113426VERACIA SA
  415. K853266PLASTIC MOUTH BARRIER HSV-I
  416. K902259AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
  417. K230196syngo.via View&GO VA40A
  418. K250483PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
  419. K897175OLYMPUS DIRECT BILIRUBIN
  420. K152341ViSi Mobile Monitoring System
  421. K952434ENDOPORE DENTAL IMPLANT ABUTMENTS
  422. K133534MCKESSON CARDIOLOGY ECG MOBILE
  423. K872925MEGABED 1000
  424. K253118Companion Spine DIAM™ Instrumentation
  425. K925747DRYSLIDE(TM) INDOLE
  426. K142785PRODIGY iConnect Blood Glucose Monitoring System
  427. K181897Reprocessed Marinr Diagnostic EP Catheter
  428. K863581MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB
  429. K791093MODELS 2411/2418 VENTRICULAR-INHIBITED
  430. K900123AUTO SUTURE SURGIPORT SPIRAL SLEEVE
  431. K924110LEOCOR CORFLO PUMP -- MODIFICATION
  432. K964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
  433. K080622ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
  434. K162075NICO TRIOwand
  435. K122253PROCARE MONITOR B20
  436. K790396ULTRASONIC DIAGNOSTIC SYSTEM
  437. K100628PLASMALUXLS
  438. K992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
  439. K962833HARMAC TEMPORARY PACING CATHETER WITH BALLOON
  440. K070447NEWDEAL COMPRESSION PLATE
  441. K050888INTEGRA IMMOBILIZATION SYSTEM
  442. BK980039Blood Establishment Computer Software and Accessories
  443. K041665L1-PRO SYSTEM
  444. K093862CAREVENT HANDHELD CPAP SYSTEM
  445. K760362LANCET, BLOOD, STERILE STAINLESS STEEL
  446. K831516GORE-TEX SURGICAL MEMBRANE
  447. K902269ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
  448. K841280SOLOPAK BRAND FILTER NEEDLE W/5 MICRO
  449. K854359LM2000A SURGICAL SUCTION MONITOR
  450. K003332MEDITHERM MED2000
  451. K222666X-View 3D Pan/X-View 2D Pan
  452. K161597Tyber Medical BioTy® Nanotopography Trauma Screw
  453. K913697AUTOMATIC CORNEAL SHAPER
  454. K222037Selectra Lead Implantation System
  455. K171717AUTOCON III 400
  456. K973545VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
  457. K012582AMEDITECH IMMUTEST DRUG SCREEN PCP
  458. K231079LW Retraction Cap
  459. K932093AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
  460. K052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
  461. K062244OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
  462. K063839POSITIONER
  463. K963916IMMULITE CANNABINOIDS
  464. K080466ALCOHOL PAD
  465. K853946SONOLINE LX
  466. K864368SCHULDT* PLUS 8 T.E.N.S. DEVICE
  467. K791007STAT DIFF STAIN
  468. K220270Aspirex Thrombectomy System
  469. K834525ANGIOSCAN FLO MAD SPECTRUM ANALYZER
  470. K964693ELECSYS FSH ASSAY
  471. K090102NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
  472. K914727SEQUENCE LIGHT CURE ADHESIVE
  473. K090611REVOLUTION FULL CORE BIOPSY
  474. K172129HS40 Diagnostic Ultrasound System
  475. K790800CENTRIA T4 RIA TEST SET
  476. K981275SYNTHES (USA) RATCHETING DISTRACTOR
  477. K003267SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
  478. K213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
  479. K991389ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
  480. K923786POLYDOROS XS50 AND SX80
  481. K861965UNITEK CERAMIC BRACKET SYSTEM
  482. K181188EVEREST Spinal System
  483. K211860Powder Free Nitrile Patient Examination Gloves, Blue Color
  484. K110545SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
  485. K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE…
  486. K970782IMAGING JET SYSTEM
  487. K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)
  488. K023630ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
  489. K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
  490. K930067BUFFALO FILTER SURGICAL MASK
  491. K071721ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
  492. K072507ENDOWAVE INFUSION SYSTEM
  493. K130410DENTAL UNIT WITH CHAIR
  494. K882047ENTRUST(TM) MODEL 800
  495. K882339BIO*NEPHROSS I.Q. ANDANTE
  496. K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
  497. K073646MINITAPE URETHRAL SLING
  498. K863416RAYLOR MINI-PROBE
  499. K800908CAPIK-CANDIDA ALBICANS IDENT. KIT.
  500. K252570EzSensor HD, EzSensor UHD
  501. K770908PROSTHESIS, HIP, TRAPEZOIDAL-28
  502. K971146LAPARETTE
  503. K811473MUELLER HINTON AGAR W/5% SHEEP BLOOD
  504. K010788SIMPLICITY SOFT QD EASY INFUSION SET
  505. K014038PYLORITEK VP TEST KIT 5140VP
  506. BK960012Device, Warming, Blood and Plasma
  507. K982446DYNAMIC SHIELDING RADIATION TABLE
  508. K202632Electric wheelchair (S7204/S7205)
  509. K862691STOPCOCK
  510. K952844HUMID-VENT 2
  511. K010133VERSALUX
  512. K873507LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM
  513. K092246NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
  514. K874395RESPIRGARD II NEBULIZER SYSTEM
  515. K930246MAMMORX
  516. BK870001Centrifuge, Blood Bank for in vitro Diagnostic Use
  517. K024013SUN-RAIN ULTRASONIC THERAPY, SU-100
  518. K974539SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
  519. K854437CHURCHILL-H VENTED IV SET
  520. K110659MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
  521. K002897TITANIUM MIDDLE EAR PROSTHESES
  522. K233572Autofuse
  523. K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
  524. K082255QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
  525. K881259MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
  526. K071524TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
  527. K100395HARMONY VLED SURGICAL LIGHTNING SYSTEM
  528. K820624SYN-OPTICS #5200
  529. K053494OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
  530. K945564MODEL 550-DC CROSSFIRE(TM)
  531. K072790CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
  532. K840587INSTANT REPLAY
  533. K242833Legend® Acetabular Shell
  534. K121376COMPRESSION CARE FLIGHT
  535. K965178NIAGARA DUAL LUMEN CATHETER
  536. K922844BECKMAN VALPROIC ACID REAGENT
  537. K070966GSO GS1 SPINAL SYSTEM
  538. K993123QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B
  539. K861024BARD ABSORPTION DRESSING
  540. K190926Hammertoe Truss System (HTS)
  541. K173120CCM Abutment System
  542. K934978FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL
  543. K011401RAMBLER
  544. K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
  545. K870425AUTO ENTRY SYSTEM (MATE)
  546. K220261NEST-C Interbody System
  547. K062104TALKING TRACH
  548. K833294ALPHA Y-RECIPIENT SET
  549. K874959VASCULAR CLAMP
  550. K790837ARRHYTHMIA II CARDULE
  551. K033980BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
  552. K233732CoolSculpting Elite System
  553. K180299ACUVUE OASYS (senofilcon A) with Photochromic Additive
  554. K133643SYNGO, CT LIVER ANALYSIS
  555. K852994REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11
  556. K031271ONE-STEP PREGNANCY TEST
  557. K253521ECMT-100 WMD
  558. K121262MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
  559. K76124312-9170 SERIES II TOTAL HIP
  560. K970889ULTRASOUND TRANSDUCER DRAPE
  561. K871714KESTREL CONTACT LENS CASE
  562. K945259DATEMINDER CONTACT LENS CASE
  563. K002682MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS…
  564. K843640XENON XE 127/XE 133 GAS DISPENSER
  565. K901120KOAGULAB 60-S COAGULATION SYSTEM
  566. K261665CORUS™ Navigation System-GN
  567. K923947MEADOX SURGIMED BALLOON CATHETER
  568. K905687ZIRCONIA CERAMIC MODULAR HEADS
  569. K853811HARD CONTACT LENS SOAKING SOLUTION
  570. K141493PROXIMAL HUMERUS PLATING SYSTEM
  571. K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
  572. K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
  573. K040078CANNON II PLUS
  574. K821533HEMATOXYLIN I
  575. K964510UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
  576. K872818REFLOTRON BILIRUBIN
  577. K001082STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
  578. K940011MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
  579. K953655J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
  580. K040716BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
  581. K915625INTRODUCER CATHETER
  582. K833484COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC
  583. K894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
  584. K990660NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE…
  585. K890795RESPIRONICS SEALEASY II
  586. K950330DIGITAL IMAGE ACQUISITION SYSTEM
  587. K131990OXYGEN GENERATOR LIQUEFIER - (OGL)
  588. K192403VK100 Percutaneous Vertebral Augmentation System
  589. K082511MEDIGARD BLOOD COLLECTION DEVICE
  590. K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…
  591. K811667COLTENE PRESSURE SPOT INDICATOR
  592. K912974MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
  593. K910608PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
  594. K946056ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)
  595. K173314LessRay System
  596. K212535Nitrile Powder Free Blue Examination Gloves, Non-Sterile
  597. K080177WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
  598. K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
  599. K920305PHARMASEAL CLEAR HUB SPINAL NEEDLE
  600. K891067PATIENT EXAMINATION GLOVE, VINYL
  601. K122183AUGMENT AND SCREW, PSA TYPE
  602. K082740GC AADVA ZR DISK
  603. K202788Sonomed IV, Sonomed V
  604. K862104MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
  605. K083155HD CAMERA HEAD OTV-S7PROH-HD-L08E
  606. K251791Auxano® Wedge Fixation System
  607. K965072PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
  608. K960226DG 88
  609. K950192SKYTRON SKYBOOM SERIES
  610. K052055SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
  611. K073529DEPUY SIGMA PS FEMORAL COMPONENTS
  612. K950279TOMTECP90
  613. K153543WHILL Model M
  614. K870775ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
  615. K170797wettrust D2care
  616. K904234MENS-O-MATIC I
  617. K080804BUSSE PLASTIC LOR SYRINGE
  618. K915733STERI-OSS DRILLS AND TAPS
  619. K190873Infrared Ear/Forehead Thermometer
  620. K034046RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
  621. K981270IRMA BLOOD ANALYSIS SYSTEM
  622. K103603ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
  623. K031218MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
  624. K061326VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
  625. K915364CHRONOCOR VI MODEL 5012
  626. K964243HUMERUS WIRES
  627. K880107CAMPY BROTH
  628. K240277MiroDry Wound Matrix
  629. K812375BABY CHICK BLOOD IN ALSEVER'S
  630. K963124PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)
  631. K230049SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…
  632. K202835Auryon Atherectomy System
  633. K860215MAGNESIUM REAGENT SET
  634. K962761REIGEL TUNNELING DEVICE
  635. K950522CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
  636. K222719CX50N
  637. K872012LECTEC NON-INVASIVE PACING ELECTRODE
  638. K940432MICROCOAGULATION PROTHROMBIN TIME TEST
  639. K801417PACEPATH MODEL 819
  640. K855069SPIROMETER TS-400 SLZ 7547
  641. K823301MICROPAD
  642. K072887G-TRAINER MEDICAL
  643. K201269Accula Strep A Test
  644. K873763BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
  645. K945563CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))
  646. K872538VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
  647. K052059IUI CATHETER, MODEL 9057
  648. K801413AMERLEX DIGOXIN RIA KIT
  649. BK100040Multi-analyte Controls Unassayed
  650. K911932J105 JAMES SURGICAL SYSTEM I/A PACK
  651. K971046HANDIFLEX
  652. K875198DIGITAL NUCLEAR IMAGING SYSTEM
  653. K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
  654. K051652ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT
  655. K923481PHILIPS LASER DISK ARCHIVE
  656. K771230PERCUTANEOUS INTRODUCER SHEATH SET
  657. K183676DentiqAir
  658. K834417CAMPY BRUCELLA AGAR PLATE
  659. K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
  660. K922139VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
  661. K850607AMDINOCILLIN 10 MCG SENSITIVITY DISCS
  662. K953020ACS GENTAMICIN
  663. K052236BARD ATLAS PTA BALLOON DILATATION CATHETER
  664. K964590COLORMATE III
  665. K193022Retractable Safety Insulin Syringe
  666. K810602EMIT-ST SERUM BARBITURATE ASSAY
  667. K942530ART-ASSIST MODEL AA-1000
  668. K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
  669. K213394Vy Spine™ VySpan™ PCT System
  670. K202959PolyLock Plating System
  671. K180286Polyethylene Catheter
  672. K021945PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
  673. K993458POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
  674. K952050GLOVE, EXAMINATION, VINYL
  675. K001511O-LAS OPHTHALMIC PHOTODISRUPTOR
  676. K061910SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
  677. K882206SUPERMON ARRHYTHMIA MODULE 7270
  678. K761049KENATRON EPILATOR
  679. K101451APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
  680. K853176CANNON BABYSAFE NIPPLE SHIELDS
  681. BK130081Automated Blood Cell Separators
  682. K030150LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE…
  683. K023021MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
  684. K881558TRYPTOSE AGAR
  685. K924613CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301
  686. K142514UniWeb 8.0
  687. K242874Gating Reflector Block
  688. K193030Avenir Muller Stem, Avenir Cemented Hip Stem
  689. K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…
  690. K890159TOWEL CLIPS
  691. K872347DIGOXIN FPIA CONTROLS
  692. K840823TREONIC C30
  693. K252619QSCHECK UISACR
  694. K860551ETP 180 CARDIAC PACEMAKER (EXTERNAL)
  695. K051797FUTURE WASH/YPS
  696. K031917MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
  697. K123525GRIDLOCK PLATING SYSTEM
  698. K896024MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
  699. K864064LATEX SURGICAL GLOVES
  700. K880118MOELLOERS DECARBOXYLASE, ARGININE
  701. K253609TRAUMAGEL® 2.0 Hemostatic Gel
  702. K970445VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX…
  703. K991973CAPIOX SX10 HARDSHELL RESEVOIR
  704. K770180SUB. OF DIACETONE ACRYLAMIDE
  705. K974713BARD HYDROPHILLIC COATED GUIDE WIRE
  706. K240644Medical Diode Laser (S1Pro)
  707. K172130Resorbable Mesh Device
  708. K843068HEARING AIDS 372 & 372 AI
  709. K760863PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
  710. K991385DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
  711. K895735DESERET MULTILUMEN SUBCLAVIAN CATHETER
  712. K260178Pelvic Muscle Trainer (KM510, KM516B)
  713. K891062TERUMO AV FISTULA NEEDLE SET
  714. K915140PRIMARY DRESSING TRAY
  715. K134029BELTER BLOOD PRESSURE METER
  716. K974288ZEROWET SPLASHIELD
  717. K792235COAGULASE PLASMA
  718. K050555BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
  719. K141329RADSPA
  720. K853951ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
  721. K081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
  722. K970218IS-ANTI-SSA TEST SYSTEM
  723. K970139MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
  724. K141825IDEAL Locking Plate System
  725. K042007ZOLL E SERIES DEFIBRILLATOR
  726. K864817S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS
  727. K000166SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
  728. K081145MODIFICATION TO 4CIS VANE SPINE SYSTEM
  729. K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control…
  730. K053431ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
  731. K254109G-CEM UNIVERSAL
  732. K040055POLYLASE LP
  733. K990785TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS
  734. K010595DJ ORTHOPEDICS INTERFERENCE SCREW
  735. K012452MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
  736. K091675LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC…
  737. K003956BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
  738. K162747Proture Double Electric Breast Pump
  739. K202849Everyway Analog OTC TENS, model N103A/N302
  740. K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA
  741. K121289LTM-LABAROSCOPIC SURGICAL MESH
  742. K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…
  743. K780963X-RAY SYSTEM
  744. K103599UNIVERSAL DIGITAL INTERFACE (UDI) 1717
  745. K931488KSF SPINAL FIXATOR
  746. K831709AUDIOSCOPE #23000 W/71123 CHARGING STAND
  747. K904659DR. DEDO'S FAMILY EAR EXAMINATION KIT
  748. K915452ANESTHESIA BREATHING CIRCUIT
  749. K924096CMV ELISA TEST SYSTEM
  750. K935180ALANINE AMINOTRANSFERASE (ALT) TEST
  751. K7719725UM FILTERSET WITH Y-INJECTION SITE
  752. K212733Diode laser therapy device
  753. K062524OCTAX LASER SHOT SYSTEM
  754. K861510MULTILUMEN VIAPIC CENTRAL LINE CATHETER
  755. K833907CREIGHTON FIXATOR
  756. K885171MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
  757. K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…
  758. K921479DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
  759. BK070054System, Test, Automated Blood Grouping and Antibody
  760. K232333Anti-bacterial bandage
  761. K253777Ascblue (8010)
  762. K914968DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
  763. K051047COLLOSS E BONE VOID FILLER
  764. K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
  765. K973222SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
  766. K842951MAXITHINS BODY-SHAPED PANTY SHIELDS
  767. K820337IMPACT, MODEL 303
  768. K111870AMSCO WARMING CABINET
  769. K152111Symmetry Surgical Quad-Lock Container System
  770. K110983CENTRIMAG DRAINAGE CANNULA KIT
  771. K023699CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
  772. K920463ZIPPIE 3 TS/SP WHEELCHAIR/STANDER
  773. K153219ProFlu+ Assay
  774. K111245HEARTNAVIGATOR RELEASE 1
  775. K771553SPIRAL SCALP ELECTRODE, 14499A
  776. K885026HOUVA II UVB
  777. K961922RDP-2
  778. K990575TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
  779. K760878BONGORT ILEOSTOMY POUCH
  780. K032236DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
  781. K071121TRIBONE 80
  782. K941615AXSYM VALPROIC ACID
  783. K210438Versana Premier
  784. K212807Surgical Masks
  785. K081997PERFADEX WITH THAM
  786. K031908MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA…
  787. K162226Reliant Multistage Dilatation Balloon Catheter
  788. K854886WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
  789. K832071TOTAL CO2 REAGENT SET
  790. K140671OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
  791. K991305HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
  792. K2405298F Modified Sheath System
  793. K834451COAXIAL BALLOON GASTROESOPHAGEAL DILA
  794. K770405OVERLOAD WARNING DEVICE
  795. K013033MODIFICATION TO: HL168W TOUCH SCREEN
  796. K253690LungMaps
  797. K843165ULTRASOUND 72X & ANNULAR ARRAY SCAN-
  798. K841671FALL-SAFE MONITOR
  799. K830131ARTERIAL BLOOD FILTER AF-1025-AF-1025BL
  800. K892002NEOCHROME(R) III GLUCOSE
  801. K023894ST AIA-PACK AFP ENZYME IMMUNOASSAY
  802. K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
  803. K892021SUNNY TEX (PATIENT EXAMINATION GLOVES)
  804. K820259STERILE CYTOLOGY BRUSHES
  805. K083686BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
  806. K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
  807. K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
  808. K781769IRON 59 KIT
  809. K861946PTK PLUS. HOME PREGNANCY TEST
  810. K151239NMI DUAL PORT II
  811. K801832MODEL 9200 VIS-U-SCAN
  812. K931795TELERAD STAT
  813. K142283Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
  814. K821723BI-4520 DUAL IMPEDOMETER
  815. K860355BOVINE CHEMISTRY CONTROL I.X AND II.X
  816. K892457TELSTAR MODEL 1/3 ITE HEARING AID
  817. K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
  818. K802419AO NON-CONTACT II TONOMETER
  819. K142315MINOP Disposable Introducer 26F
  820. K202748Enteral Feeding Catheter
  821. BK060027Device, Warming, Blood and Plasma
  822. K873579AMBU RMT VALVE
  823. K183541ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
  824. K123102SOVEREIGN MINI
  825. K102930FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
  826. K926585THOROCOSCOPY SELF-RETAINING RETRACTOR
  827. K905200SACA, 3.5 MHZ PROBE
  828. K091548AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
  829. K092820POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
  830. K972292SOLIDEX
  831. K896740AXIAL AND OFFSET CROSSLINK PLATES
  832. K911095GSI 37 AUTO TYMP
  833. K881194RIA-QUICK
  834. K864280ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT
  835. K080093PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
  836. K012791C.T.M. MOBILITY SCOOTER MODEL # HS-320
  837. K7804072C7125 BLOW BOTTLE
  838. K0006903M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
  839. K191181NXPRO Neuromuscular Electrical Stimulation Device
  840. K800266CAMPYLOBACTER GROWTH SUPPLEMENT
  841. K864740BONE MARROW COLLECTION MEDIUM
  842. K021955TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS &…
  843. K200615Signature ONE System
  844. K232567Myriad SPECTRA Light Source
  845. K984392ANSELL CONDOMS
  846. K161795MAGNETOM ESSENZA
  847. K974193NARKOMED ULTRASONIC FLOW SENSOR
  848. K210855Straumann BLX Implant System
  849. K093516NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
  850. K920361BARD BILIARY BALLOON DILATORS
  851. K950651TOTAL SHOULDER PROSTHESIS
  852. K241111AMT Suture Passer
  853. K111307AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
  854. K171443Etherea MX
  855. K896301MODEL 340 PROBE MIC SYSTEM
  856. K002611SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
  857. K905434ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102
  858. K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
  859. K203689Tidepool Loop
  860. K990331SURGEN VALVE
  861. K853529IMPREGUM-F
  862. K994368AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
  863. K073460SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
  864. K231385Rology Teleradiology Platform (v.1.22.1103)
  865. K870356TATCH-IT
  866. K210816True Tulip, True M.I.S.
  867. K914413SPECTACLE FRAMES
  868. K011164MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
  869. K812168CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.
  870. K161239MTA2.2 MATERIAL
  871. K023617DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
  872. K900322CO/CMD-1
  873. K193084TIB Abutment System
  874. K112302PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE &…
  875. K113182EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
  876. K213405MINE ALNU (Model: Mine 2.1)
  877. K213450Medical surgical mask (Black mask, Level 1 and Level 3)
  878. K0503267350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
  879. K042142CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
  880. K811711PEDIATRIC OXYGEN MASKS
  881. K930002ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
  882. K111696OPAL BAND CEMENT
  883. K220228Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With…
  884. K781031AEROPLAST DRESSING
  885. K061476ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
  886. K915740DISPOSABLE O.R. TOWEL, STERILE
  887. K182034Arterys MICA
  888. K974215VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
  889. K840011RESOLVE-HB
  890. K913163NON REBREATHING VALVE
  891. K800684REAGENT FOR DETERM. CREATINE PHOSPHOKINA
  892. K252393VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
  893. K121462EZ-BLOCKER
  894. K854378DEPEND FITTED BRIEF
  895. K182199NFC-700 non-mydriatic auto fundus camera
  896. K902853GRAVITY PLUS CONTROLLER/COMPOUNDER
  897. K133758CENTERVUE MACULAR INTEGRITY ASSESSMENT
  898. K203409MC3 Crescent Jugular Dual Lumen Catheter
  899. K822395CF 1211 CAPILLARY FLOW DIALYZER CODE
  900. K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…
  901. K120010CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
  902. K041123RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
  903. K982211PROFILE-II MODEL 600582
  904. K1410273D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II…
  905. K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
  906. K083712WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
  907. K182418V3 Segmental Plating System
  908. K851593SELECTIVE STREPTOCOCCUS AGAR
  909. K831003MEASURE-UP MUSCLE STIMULATOR
  910. K980903RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
  911. K010099ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
  912. K922989WILTEK IRRIGAITON/ASPIRATION TUBE SET
  913. K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
  914. K191731Instylla Microcatheter
  915. K032492BLOOD PRESSURE MONITOR, MODEL KP-7000
  916. K915209MALECOT-NEPHROSTOMY TAMPONADE CATHETER
  917. K925630ELASTOPLAST HEAT PLASTER
  918. K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
  919. K023454DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
  920. K952779KARL STORZ FLEXIBLE HYSTERSCOPE
  921. K902228MODIFIED EPICARDIAL ARRAY
  922. K022386POCKETCHEM UA AUTION STICKS 10TA
  923. K053030J. MORITA AZ ULTRASONIC SYSTEM
  924. K952015PRIMA FILTER
  925. K052118DOSE VERIFICATION SYSTEM
  926. K830522STAINLESS STEEL SUTURE 316L
  927. K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
  928. K781813SOLUTION ADMINISTRATION, TIP PROTECTOR
  929. K192807Duo-Flow Side x Side Double Lumen Catheter
  930. K780027ACCELERATOR, LINEAR, MED.
  931. K891532M-70 GOLD BASE DENTAL ALLOY
  932. K152587DermaScalp Laser Cap
  933. K120052CVINSIGHT
  934. K951935PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
  935. K003361RENEW LS-2
  936. K111142ECHOSOFT(TM)
  937. K124033MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
  938. K060564INFINITI SYSTEM
  939. K011427MBI PD-103 SL; MBI PD-103 SH
  940. K853572MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410
  941. K915508DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
  942. K180825Fluent Fluid Management System
  943. K897113PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
  944. K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
  945. K770821PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT
  946. K910242EF SYNERGY QUAD MODIFIED
  947. K202844Medical Surgical Gowns
  948. K772088AMES T-3 UPTAKE STRIP TEST
  949. K970110BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
  950. K033337ULTRAPRO MESH
  951. K841658KF STREPTOCOCCUS AGAR
  952. K922508RUBBER FRAME SUNGLASSES
  953. K123984QUANTIEN MEASUREMENT SYSTEM
  954. K771992L-501 CARDIAC PACEMAKER
  955. K191536Biatain Silicone Ag
  956. K083035DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
  957. K133976FUJIFILM ENDOSCOPIC CO2 REGULATOR
  958. K040044HEEL SNUGGLER, MODEL 99047
  959. K002261MR-III
  960. K922000MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL
  961. K792465CONNECTICUT DIAGNOSTICS, LTS. DIRECT
  962. K881792CANNULA MODEL AR-6551
  963. K142417SP-1PSpecular Microscope
  964. K840771ALCOHOL & AMMONIA CALIBRATOR I
  965. K133412S200, S300
  966. K952418V40 ZIRCONIA FEMORAL HEADS
  967. K854818SUNGLASSES
  968. K896922RAICHEM TM HEMOGLOBIN REAGENT
  969. K032960WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
  970. K012824ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
  971. K242286Superflow Prime Treatment System (ASP-1M)
  972. K851542RFA-300 RAPID FLOW ANALYZER W/COMPUTER
  973. K812104SIEMENS-ELEMA PSA 376
  974. K132105PERCLOT TOPICAL
  975. K771969TURBO-JET MODEL 76
  976. K143103PROPENCIL Smoke Pencil
  977. K032894OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…
  978. K963852KSEA THERMOCOAGULATOR (MODEL 265100 20)
  979. K780260TEMP. SENSOR W/22MM FITTINGS
  980. K991023STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02…
  981. K800366SOLARIUM, MODEL 6040A
  982. K230825Smileyscope System (Therapy Mode)
  983. K233574Total Wrist Arthroplasty System (TWA)
  984. K900658INTRODUCER, PERCUTANEOUS
  985. K230404BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
  986. K892958TACCTILE PATIENT EXAMINATION GLOVES
  987. K974572GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
  988. K924120MOLDED FIBER CAP DELIVERY SYSTEM
  989. K770407SHIELD, DENTAL X-RAY, PROTECTIVE
  990. K041965ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
  991. K110158ILLUMINATING SINUS SEEKER
  992. K945970INSUFFLATOR FILTER TUBING SET
  993. K050094LADY COMP USA
  994. K973669THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
  995. K842290SPOT TEST NINHYDRIN REAGENTS
  996. K040891KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
  997. K100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
  998. K873268MUELLER HINTON MEDIA
  999. K872166FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
  1000. K251866Tegaderm Post-Op Transparent Antimicrobial Dressing

About this dataset

A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database