Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K895360C.P.A.P. VALVE AND C.P.P.A. KIT
  2. K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL…
  3. K920159MOBILE MRP-7000
  4. K093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
  5. K043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
  6. K140039POLYCRYL
  7. K831355EMIT QST QUINIDINE ASSAY
  8. K872377CHROM-TROL
  9. K974585IF-727 INTERFERENTIAL STIMULATOR
  10. K792071DCG DATA TERMINAL
  11. K052214PRE-POWDERED STERILE EXAM GLOVES
  12. K834512SANDMILL RMS
  13. K142361Discovery MR750 3.0T
  14. K250268HyperSnap Surgical System (HSS)
  15. K983165OSTEO 4.0MM CANNULATED SCREW SYSTEM
  16. K241613Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
  17. K020037DRIED GRAM NEGATIVE MIC/COMBO PANELS
  18. K211379syngo.via RT Image Suite
  19. K112482SELECTRA SLITTER TOOL
  20. BK220669System, Test, Automated Blood Grouping and Antibody
  21. K173240Arthrex PushLock
  22. K833737CPR LOCATOR
  23. K201730Powered Inflatable Tube Massager - SLIM UP DRAIN
  24. K981156DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
  25. K141946DIGITAL ELECTROCARDIOGRAPH
  26. K864142UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
  27. K022604POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
  28. K962446SHARPLAN RUBY LASER SYSTEM
  29. K820374JLS GROUP INFANT MONITOR
  30. K955303DIASTAT ANTI-CARDIOLIPIN KIT
  31. K200717CLEWICU System (ClewICUServer and ClewICUnitor)
  32. K022629WMT-TCP BONE GRAFT SUBSTITUTE
  33. K233722RADspeed Pro
  34. K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
  35. K833130TRI-COUNT 7
  36. K052625BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
  37. K120078HEALIX ADVANCE BR ANCHOR
  38. K141804POLARIS SPINAL SYSTEM - HA COATED
  39. K943290BILIRUBIN PLUS/PEDIATRIC CONTROLS
  40. K030620PASCO MIC AND MIC/ID PANELS
  41. K862152TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD
  42. K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
  43. K170375Nobilplast Denture Resin
  44. K242650zLOCK Lumbar Facet Fixation System
  45. K800508STOMACH TUBES
  46. K781632UROTRON
  47. K772392ALLPORT MASTOID RETRACTORS
  48. K0604188F SHERPA NX GUIDE CATHETER
  49. K924390ANGEMED 5000 LEAD ADAPTER
  50. K970041ASCEND BALLOON DAILATION CATHETER
  51. K040555IMPAX CLIENT EMBRACE
  52. K213674CellFX System
  53. K945839SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA
  54. K170844Gemini-C Hybrid Cervical Interbody System
  55. K921917DOLOMITE ROLLATOR
  56. K973310TBD* ONE-STEP OVULATION PREDICTOR TEST
  57. K182327Patient Cables and Leadwires , Disposable ECG Leadwires
  58. K903908REPAK SURGICAL PACKS
  59. K152072CrossRoads Screw System
  60. K973856GIOTTO HT
  61. K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)
  62. BK150294Platelet And Plasma Separator For Bone Graft Handling
  63. K141484OPEN FMSEALER
  64. K010852OSMED TISSUE EXPANDER
  65. K904327ADVANCED C- SPINE COIL
  66. K862914FEKAL CHECK PARASITOLOGY CONTROL SLIDE
  67. K803314SKIN BEAUTY CLEANSER & TONER
  68. K990510JMS APHERESIS NEEDLE
  69. K913207TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE
  70. K223901ApneaRX Pro
  71. K911817ENDOSCOPIC CLIP APPLIER
  72. K030593FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON…
  73. K000769KSEA MANHES PNEUMOTROCAR
  74. K990952NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
  75. K063776ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
  76. K801973IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA
  77. K872622ORTHODONTIC ARCH
  78. K003681BIO-LOGIC SLEEPSCAN NETLINK
  79. K920165SUNGLASSES (NON-PRESCRIPTION)
  80. K792554ELVI MUCAPROTEINS
  81. K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
  82. K881256NON CORING INFUSION SET
  83. K000072DORNIER MEDILAS D SKINPULSE
  84. K153371Sonicision Cordless Ultrasonic Dissection Device
  85. K954321ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)
  86. K810907COLTENE ORALLY
  87. K000836BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
  88. K781497LIFELINE PACING LEAD MODEL 465-01
  89. K212050NGM WAVE PLIF Cage
  90. K981553AUTOMATED MEDICAL REPORT WRITER
  91. K022960GE QUASAR NUCLEAR MEDICINE SYSTEM
  92. K896309MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
  93. K924079CFM-800 COLOR FLOW MAPPING SYSTEM
  94. K933194THE SIGNATURE SERIES, IMC IV
  95. K930493QUANTUM 3080 SURGICAL TABLE
  96. K870371TOTAL PROTEIN REAGENT - BIURET METHOD
  97. K780665RECAP
  98. K911668CERAPALL 2
  99. K160901Xpert Carba-R
  100. K212800PRIMA Humeral System and SMR Glenosphere Ø42
  101. K160730Instrument kits
  102. K030180CRESCENT TINNITUS RETAINING SOUND GENERATOR
  103. K994141CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL…
  104. K922371SPINAL POSITIONING FRAME
  105. K070384ARGON CONTINUOUS FLUSH DEVICE
  106. K053420TENACORE SP02 SENSORS
  107. K772227CATH KIT, SUPERPUBIC
  108. K093008HALO ABLATION CATHETER, MODEL 90-9100
  109. K152304Tritanium PL Cage
  110. K863960STOCKERT-SHILEY CAPS BATTERY MODULE
  111. K234040TriMed Threaded Intramedullary Nail System
  112. K013537ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200…
  113. BK890021Kit, Quality Control for Blood Banking Reagents
  114. K791057CAST BRACE COMPONENTS
  115. K191454Atellica CH Amylase_2 (AMY_2)
  116. K131408CR 12-X DIGITIZER
  117. K041556MODIFICATION TO VERTE-STACK SPINAL SYSTEM
  118. K230897Anterion
  119. K935083PEDIATRIC DEFIB K-PADS
  120. K162265CushionCast Moldable Cushions
  121. K091008STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
  122. K122336Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
  123. K182424NuFACE FIX Skin Toning Device
  124. K963519EUROLINE A-675 SERIS
  125. K032581GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
  126. K902282ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE
  127. K872024CO2/02 MONITOR MULTINEX
  128. K891974PATIENT EXAMINATION GLOVES (LATEX)
  129. K870401WAKO(TM) AUTOKIT LDH
  130. K791781TUBE-STRAP
  131. K953400GUEDEL AIRWAY
  132. K041069SPIRALOK ANCHOR
  133. K873112PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
  134. K963188DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
  135. K883863GENESIS 180
  136. K071520RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
  137. K850694WSP CODE 4310 STRESSCATH
  138. K041777MODIFICATION TO CD HORIZON SPINAL SYSTEM
  139. K061843VENTURE WIRE CONTROL CATHETER, MODEL WCC
  140. K902793RUBELLA IGG
  141. K071793CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
  142. K974280ABUTMENT - COMPLETE
  143. K853704LINK DYNAMIC STAPLE
  144. K932106MOBILETT PLUS MOBILE X-RAY SYSTEM
  145. K902079ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION
  146. K840007SURGICAL SUCTION INSTRUMENT-REUSABLE
  147. K014296CD HORIZON SPINAL SYSTEM
  148. K823006MEDEVICES ASPIRATION HOSE
  149. K860146POLYJEL N.F. (NEW FORMULA)
  150. K882994DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3021
  151. K233265Monotime and Optime R
  152. K040911VITALHEAT
  153. K781579MODIFIED STERILE DISPOSABLE STOPCOCKS
  154. K942583PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
  155. K161939Avance Abdominal Dressing Kit
  156. K934940MIRACLE-EAR ENTRE
  157. K780301CAULK TYLOK
  158. K182950Acare Suction Unit
  159. K163584M3290B Philips IntelliVue Information Center iX
  160. K934011MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
  161. K083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
  162. K900416HAND CONTROLS, MODEL 3700 AND 3500 SERIES
  163. K091345GOPHER GOLD CATHETER, MODEL 5620
  164. K051121DIRECT LDL CHOLESTEROL, MODEL L530-60H
  165. K131878LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
  166. K890323MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
  167. K900226DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
  168. K092656LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
  169. K923661QUADRASORB FILTER
  170. K823173ARRIRM SCRUB BRUSH/SPONGE
  171. K043188ALCOHAWK PRECISION
  172. K252753Vydence Family of Lasers
  173. K831745BASAL MEDIUM EAGLE W/EARLES SALTS, &
  174. K940569DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
  175. K050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
  176. K090481DEMASQ IMAGING SPFTWARE DEVICE
  177. K160821Tria Sapphire
  178. K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle…
  179. K150377Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony…
  180. K050092R605 FACS COLLIMETER
  181. K001208ESPIRT
  182. K931417STERILE EQUIPMENT COVERS
  183. K242863Bioptimal Bipolar Pacing Catheter
  184. K875081IMMPULSE T4 ASSAY REAGENTS
  185. K230731Zavation ALIF System
  186. K080604PRESSURE INJFECTABLE PICC
  187. K200191Sirona Dental CAD/CAM System with InLab Software
  188. K083843LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
  189. K950334KARL STORZ TELE-SCRUB
  190. K832385CRYOPROBES MC-1400-CRYOSURG-CONSOLE
  191. K874178BIOTIS (TM) BCYE SELECTIVE
  192. K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…
  193. K974207PHILIPS EASYVISION WORKSTATION
  194. K894524FPR GENTAMICIN CALIBRATOR KIT
  195. K894529FPR THEOPHYLLINE KIT
  196. K151197Lariat snare
  197. K051044ARCTEC SEMIRIGID PLATING SYSTEM
  198. K944180MODEL 700
  199. K991477SPIN SNAP-OFF SCREW
  200. K861556MODIFIED FETAL MONITOR MODEL FM-2
  201. K8601235.0 MHZ INTRAOPERATIVE ARRAY
  202. K183613exGraft, exGraft Carbon
  203. K865024ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER
  204. K042507UBIPACS
  205. K062198SUNSPOTS PRE-GELLED SURFACE ELECTRODES
  206. K063491T2 SCEPTOR SPINAL SYSTEM
  207. K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
  208. K103598PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
  209. K123248CPR RSQ ASSIST
  210. K871168INSTANT COLD COMPRESS, CHEMICAL TYPE
  211. K802076STIFF STYLETS
  212. K152707Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
  213. K000926EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
  214. K823334PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630
  215. K924119VENTREX ALLERGEN DISC
  216. K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
  217. K042203LEONARDO SYNGO CARDIOLOGY WORKSTATION
  218. K030323MRI-CADDY
  219. K974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
  220. K011698STRAUMANN GBR SYSTEM
  221. K862430SIEGEN HEADPHONES
  222. K012199DIGICAP
  223. K9919613M LVR SYSTEM
  224. K110757TL-CERMIDE SKIN BARRIER EMULSION
  225. K021856PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX…
  226. K833292LACTABACILLUS AGAR W/O TWEEN80
  227. K142774Polysmith Sleep System
  228. K872061LP LATERAL FLUORO POSITIONER (B5077A)
  229. K163607ECG Acquisition Systems
  230. K802308T/K (ATA/AMA) UNIVERSAL BIOPAK
  231. K781670STIMULATOR, E.S.I. NEURO
  232. K991572ISOLUX SURGICAL HEADLIGHT
  233. K941589SYRINGE FILTER DEVICES
  234. K172980Micropuncture Pedal Access Set
  235. K233770Pepper EMS Training System
  236. K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
  237. K093106ENDOSCOPE REPROCESSOR OER-PRO
  238. K813123EPC FILTER
  239. K915201CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO
  240. K965213STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
  241. K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
  242. K243703TechLive
  243. K770980EMATOLOGY DILUENT RESERVOIR CLOSURE
  244. K030332MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
  245. K022532TISSUELINK BIPOLAR FLOATING BALL DEVICE
  246. K981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND…
  247. K913839OPTICA 25 ND:YAG DENTAL LASER SYSTEM
  248. K233187Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
  249. K253316PhAST instrument and PhAST Blood Culture Gram-negative Panel
  250. K821372DESERET INTRACATH INTRAVENOUS CATHETER
  251. K092302POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
  252. K032901STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
  253. K981915TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
  254. K921475A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM
  255. K913184MS-III MINISTIM
  256. K810491TYPE YC ENDOCARDIAL LEAD
  257. K152174Sniper Spine System
  258. K897047LATEX PATIENT EXAMINATION GLOVES
  259. K100042DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
  260. K993861FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
  261. K942246PURITAN-BENNETT NASAL CPAP MASK
  262. K133941MITEK ARTHROSCOPES
  263. K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with…
  264. K012505SOPRO595 INTRA ORAL CAMERA
  265. K923894YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
  266. K132171AIXPLORER
  267. K192172Connected OR Hub with Device and Voice Control
  268. K130360CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
  269. K981404FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
  270. K941740ACUFEX ROTATOR CUFF FIXATION BUTTON
  271. K000935KFA-63 KNEE AND FOOT ARRAY
  272. K133501LEADLINER CS LEAD DELIVERY SYSTEM
  273. K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5…
  274. K230487Dental Lithium Disilicate Glass-Ceramic
  275. K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
  276. K041784RAVEN PROTEST - EO
  277. K822621ROOT CANAL FILES, TYPE K
  278. K863238READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
  279. K844916MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER
  280. K0312633M LIQUID BANDAGE, MODEL 120-LB
  281. K760198KIT, PLATELET AGGREGATION REAGENT (#390)
  282. K102820APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  283. K935553MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
  284. K1605425.0 Fr Arndt Endobronchial Blocker Set
  285. K963851TILTING RADIOGRAPHIC TABLE (REMOTE)
  286. K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
  287. K0902035.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
  288. K982315PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
  289. K2208401 Series Phototherapy Equipment
  290. K181844One Touch
  291. K210504PANAVIA Veneer LC
  292. K82179882 ALLOY
  293. K972763HEMAPROMPT
  294. K780945LIQUID CHROMATOGRAPH MODEL 860
  295. K042800LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
  296. K823466AUTO-TENS MODEL III DUAL CHANNEL REPLACE
  297. K151025iHearTest
  298. K952839BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
  299. K904149FLEXISYS
  300. K161158IDS-iSYS Intact PTHN
  301. K830000VASCULAR-ACCESS-PORT
  302. K981679TCM 3000 AND TCM ENDO
  303. K161488ESTETICA Dental Treatment Unit and Accessories
  304. K935092CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
  305. K123555KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
  306. K170703Single Use Arthroscopic Electrode (with Pencil)
  307. K050441TAPER 2 POROUS FEMORAL STEM
  308. BK010002System, Test, Automated Blood Grouping and Antibody
  309. K971742DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
  310. K222856SOMAVAC 100 Sustained Vacuum System
  311. K820918HMEM POWDERED MEDIUM
  312. K000356C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
  313. K861514VNA OPTICAL CORRELATOR
  314. K081347ILUMA VISION
  315. K030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
  316. K080460SPECTRAL OCT/SLO
  317. K8846431100 VITAL SIGNS MONITOR
  318. K955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
  319. K022650APEX MEDICAL CPAP RT 21XX
  320. K133111KINGTECH DIGITAL THERMOMETER
  321. K000579TEMPO AQUA ANGIOGRAPHIC CATHETER
  322. K892480PATIENT EXAMINATION GLOVES
  323. K951472LMT BONE ANCHOR
  324. K861528TECNOL PERSONAL SHOE COVER
  325. K893859ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
  326. K973918NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
  327. K012337BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
  328. K213176Disposable Nitrile Powder-Free Examination Gloves
  329. K872328DIGOXIN FPIA CALIBRATORS
  330. K962871ODS1 - HOOD DRIVER
  331. K212649Disposable Surgical Face Mask
  332. K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
  333. K921450NON-INVASIVE TUBING
  334. K830397PEM-C
  335. K952033IMAGYN HYSTEROSCOPE
  336. K950690PROSYS URIHESICE SYSTEM NL
  337. K913783CORDIS PTCA GUIDING CATHETER, MODIFICATION
  338. K870024PONTALLOR 4 DENTAL ALLOY
  339. K941763ELECTRONIC-AMPLIFIED STETHOSCOPE
  340. K101996DEPUY GLOBAL UNITE SHOULDER SYSTEM
  341. K903755CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED
  342. K153093FIRMap Catheter
  343. K963077TBD
  344. K173169Rapid Family
  345. K011202MSI BIPOLAR SHEATH
  346. K090105LUPOTEK KCT
  347. K790214MODIFIED JACKSON-REES CIRCUIT
  348. K041518CODMAN DURAFORM DURAL GRAFT IMPLANT
  349. K090808PINNACLE3 SMARTARC
  350. K100932INCLUSIVE MINI IMPLANT
  351. K760640FILTER SET, PMF 1024
  352. K851741ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
  353. K820214SUCROSE
  354. K913033LATEX EXAMINATION GLOVES
  355. K900740SPECIMEX DC
  356. K211548POLARSTEM Calcar Reamer Guide
  357. K132761WIRELESS THERMOMETER
  358. K780197HEARING AID, BODY WORN
  359. K932637SUBCUTANEOUS INFUSION SET
  360. K003525VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
  361. K203401Neocis Guidance System (NGS) with Patient Splints (EPS)
  362. K800035PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
  363. K123905CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
  364. K070873AMSURE BLADDER IRRIGATION SET
  365. K933919MICROLITE WHEELCHAIR
  366. K951981RXAIR 3000
  367. K884362LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
  368. K111270REUSABLE STIMULATING ELECTRODES
  369. K241927Synthes Graphic Case & Tray System
  370. K173612Optima XR646 HD
  371. BK210605System, Test, Automated Blood Grouping and Antibody
  372. K915065I.V.IRRIGATION POLE
  373. K941144EXCEL EMG
  374. K972521NAVIGATOR (STYLET) 2006
  375. K111143POLY-CHEM 90 TOTAL BILIRUBIN
  376. K840812BIOSPAL 2400S
  377. K832851AGAR 8000 TENS
  378. K081835ACTICARE IC AND TSE
  379. K934909COBALT CHROME GEMINI
  380. K891975PATIENT EXAMINATION GLOVES (LATEX)
  381. K771001STATZYME GLUCOSE
  382. K241978Shinetell Digital Pregnancy Test
  383. K790059PROACTIVATOR C3, C4 AND C3
  384. K935642EVANS MEDICAL EXTENSION SETS
  385. K771253HEMOX-ANALYZER
  386. K193172Luna XD Ti Interbody Fusion System
  387. K843497SURGICAL KNIVES & PROBES
  388. K853026BIOVATION MAX DATA MANAGEMENT SYSTEM
  389. K141783TDX SP2 POWER WHEECHAIR
  390. K173594Straumann cerabone
  391. K892444REAADS-RF TEST KIT-QUANTITATIVE
  392. K943385CLINITRON ELEXIS
  393. K951947MED-TEC RADIO THERAPY TREATMENT CHAIR
  394. K923274ZEISS VISULAS DIODE LASER
  395. K810445MECHANICAL TABLE
  396. K190213Yikang Endotracheal Tube
  397. K843181AUTOFLUOR IV SYSTEM
  398. K791963USCI MULLINS TRANSSEPTAL CATHETER INTRO.
  399. K831171DIGICATH
  400. K072714TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
  401. K960467POWDER FREE LATEX EXAMINATION GLOVE
  402. K770622CONDUCTIVITY GEL W/POTASSIUM CHLORIDE
  403. K092863MAXIFLO, TAPERFLO
  404. K902919SYNERMED MAGNESIUM REAGENT KIT
  405. K862036MODEL HP HEARING AID
  406. K841249SUCTION CANNULAS
  407. K162911Sofia RSV FIA on Sofia 2 analyzer
  408. K071436REGIUS UNITEA
  409. K903820THERA-CANE
  410. K091493ORTHO SELECT BONE PLATES AND SCREW SYSTEM
  411. K030780NEWPORT E500 WAVE VENTILATOR
  412. K251629UNiD™ Spine Analyzer
  413. K930806ZYMED HOLTER SCANNER MODEL 2010
  414. K974354MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
  415. K140104BARRICADE EMBOLIZATION COIL SYSTEM
  416. K801986DATASON DB SYSTEM
  417. K181677Kodiak Spinal Fixation System
  418. K936245MULTI ANALYTE LINEARITY SET
  419. K010107R STENT BILIARY ENDOPROSTHESIS
  420. K012651HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
  421. K861030LABOR-DELIVERY STRETCH/BED
  422. K023000HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
  423. K011502CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
  424. K180351EndoWrist Mercury Bipolar Grasper
  425. K930095SPACELABS MEDICAL PATIENT MONITOR
  426. K992630THERMALIGHT 2000
  427. K062672GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
  428. K250041Medical Picosecond ND: YAG Laser System (PZ-6)
  429. K050599TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
  430. K222304Sonata Transcervical Fibroid Ablation System 2.2
  431. K944594BACT/ALERT FAN CULTURE BOTTLE
  432. K051715STARPACS DENTAL
  433. K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
  434. K161098ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
  435. K242187BioBrace®
  436. K162590Bashan TDP Heat Lamp
  437. K223711ANNE One
  438. K212924Nitrile Examination Gloves
  439. K201853Naton Disposable Surgical Face Mask
  440. K980373ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
  441. K883071SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
  442. K880681MINI-FILTER, VIROBAC II
  443. K854920THERAPY CASSETTS
  444. K232865Magseed Pro Magnetic Marker System
  445. K131786AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
  446. K110722RPS ADENO DETECTOR PLUS
  447. K132009CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
  448. K863659FLOW INTERRUPTION INDICATOR
  449. K973154UBI MAGIWEL MARIJUANA METABOLITES
  450. K241180Consensus Knee System with TiNbN
  451. K243460Ultimate rTMS
  452. K053301CEDARA I-RESPONSE CEDARA PET/CT
  453. K130094FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
  454. K862490ANU-RX
  455. K952926QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
  456. K060536OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
  457. K012670BOSS 2000-3 VACUUM ERECTION DEVICE
  458. K853208125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
  459. K940983THE KARL STORZ UROMAT(TM)
  460. K941678BIONECTOR
  461. K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles…
  462. K953643HEMATIL 18 (H-18)
  463. K152784Pacel Bipolar Pacing Catheters
  464. K251891Electric Wheelchair (GY-E001)
  465. K780962AUTOMATED ENZYME
  466. K254152Dia-X Sil Light Body
  467. K980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
  468. K111361PLANMED NUANCE EXCEL
  469. K863181HEALTHCHECK THERM-STRIP
  470. K900858CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
  471. K882789COON'S MEDIUM F-12, CATALOG NO. 200-2066
  472. K060695IBA PROTON THERAPY SYSTEM - PROTEUS 235
  473. K880566CLP PROTHROMBIN TIME TEST
  474. K1026942.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
  475. K983997STERICHEK TOTAL CHLORINE TEST KIT
  476. BK980014Microfilter, Blood Transfusion
  477. K160427dynaMX(TM) Nitinol Compression Screw
  478. K842202NEW JERSEY ACETABULAR COMPONENT &
  479. K1730022940 nm Er:Yag Laser Handpiece
  480. K063423TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
  481. K972441RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000
  482. K050110SYNTHES (USA) LCP MODULAR FOOT PLATES
  483. K140371FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS…
  484. K872059DRIPRIDE PROVIDE ULTRA
  485. K882008ACE SCREW REMOVAL TREPHINE
  486. K122411J-SCOPE SYSTEM
  487. K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System…
  488. K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
  489. K901301STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
  490. K861021GOTTEX SUNGLASSES
  491. K060814DYNATRON ION IONTOPHORESIS ELECTRODE
  492. K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
  493. K760372HUMIDIFIER, DISPOSABLE
  494. K030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
  495. K760548CARAFE AND LINER
  496. K920747PESSARY FLEXIBLE SILICONE DONUT RING
  497. K140468BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
  498. K050442MILLENNIUM MULTI-LEAF COLLIMATOR
  499. K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
  500. K232535MAGNETOM Sola; MAGNETOM Altea
  501. K883199MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
  502. K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
  503. K850180ELECTRONYSTAGMOGRAPH (ENG RECORDER)
  504. K902960MILENIA(TM) PCP
  505. K902320BAUER FLEXI-TEMNO BIOPSY NEEDLE
  506. K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…
  507. K133514XCAGE INTERBODY FUSION SYSTEM
  508. K180227Polaris Spinal Growth System
  509. K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
  510. K821496DISPOSABLE IRRIGA/ASPIR. SYSTEM
  511. K020148pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
  512. K912994COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE
  513. K212919Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
  514. K982940LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
  515. K851622TIMENTIN 85 MCG. SENSI-DISC
  516. K861670TRIGLYCERIDE (TRINDER) PROCEDURE
  517. K891704PATIENT EXAMINATION GLOVES (LATEX)
  518. K944560MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
  519. K760872PHOTOTHERAPY LIGHT
  520. K021333ARTEMIS
  521. K873246MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2
  522. K860900IMMPULSE FREE ESTRIOL ASSAY REAGENTS
  523. K964940TAOS 28
  524. K141378IDC INTERLOCKING DETACHABLE COIL
  525. K051786MELIDE FIBEROPTIC LIGHT
  526. K111895ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
  527. K914903QUICKSTART UREA NITROGEN
  528. K882995FISCHER'S MEDIUM NO. 200-2188
  529. K896417KONTRON KOLORMON 7250 PATIENT MONITOR
  530. K201047Fusion Taper System
  531. K003275SYNTHES SYNMESH SPACER SYSTEM
  532. K173883External Fixation System
  533. K033151KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
  534. K904951S5192R TRANSDUCER
  535. K901404NUTRIMIX MACRO TPN COMPOUNDER
  536. K014289ORTHOSS RESORBABLE BONE VOID FILLER
  537. K200293InMode System with vTone Applicator
  538. K151621BioHorizons CAD/CAM Abutments
  539. K024142AIGIS-SUPER
  540. K913176DELPHIN II CENTRIFUGAL SYSTEM
  541. K781072TRAP-BLOOD VESSEL STABILIZATION DEVICE
  542. K853450STERISTORAGE CONTAINER
  543. K042107TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
  544. K833116SPIRIT CHEMISTRY SYSTEM
  545. K142022MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
  546. K834530EXTENSION BOX EB200
  547. K050695FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
  548. K200021Applied Medical Anoscope
  549. K151525Amia Automated PD System with Sharesource
  550. K050635ALLFIM IMPLANT SYSTEMS
  551. K053046ILUMA ORTHOCAT/DENTALCAT
  552. K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety…
  553. K861244HDL/CHOLESTEROL TEST SYSTEM
  554. K813603LINQUAL-ORAL TRAINING SPLINT
  555. K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…
  556. K213360SleepCheckRx
  557. K062695SAGEMAX Z-BLANK
  558. K232320iSR`obot Mona Lisa 2.0
  559. K092720WRIST ARTHRODESIS NAIL SYSTEM
  560. K030303FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION…
  561. K000448PACSSTATION
  562. K1111724 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
  563. K233451Arthrex Synergy Vision Endoscopic Imaging System
  564. K221323Exactech® Alteon® Short Tapered Wedge
  565. K142886DMRC Self-Cure Bracket Adhesive One Step and Primer
  566. K970647OUR ROTATING GAMMA SYSTEM
  567. K232361Promaxo MRI System II
  568. K771617SPECI-MIX
  569. K060836VISTADENT OC - VERSION 4
  570. K841476TUBULAR HOLLOW FIBER MEMBRANE
  571. K051848SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
  572. K953165ULTRA COMPACT VIDEO IMAGER
  573. K222034RightLance Blood Lancing System
  574. K792416ELVI TOTAL PROTEINS
  575. K142197ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
  576. K003556HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
  577. K811916OPERATING ROOM KIT
  578. K213080T-Edge 10, T-Edge 11
  579. K161883CompuFlo Epidural Computer Controlled Anesthesia System
  580. K911513TRAPEZOIDAL MALAR IMPLANT
  581. K171937Microlife Upper Arm Automatic Digital Blood Pressure Monitor
  582. K891542EBNA-CHECK(TM) TEST KIT
  583. K904711BC 1220 ANALOG - IMPLANT BODY
  584. K120858IMPLANT BAR
  585. K771392ACCU-TRODE (DISP. ECG ELECTRODE)
  586. K121290AQUAMANTRYS3 BSC 9.1S
  587. K113250DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
  588. K780799VITAMIN B12 RADIOASSAY
  589. K821030NOVA II FLUIDS PACK
  590. K242103TRIOS Ready Tip
  591. K01414780 CHANNEL EEG
  592. K902009ELANTEC'S SURGICAL TAPE REMOVER
  593. K022702POWDERED SYNTHETIC VINYL EXAM GLOVES
  594. K972895VIDAS ROTAVIRUS (RTV) ASSAY
  595. K840308CAT. 4-OBSTETRICS GYNECOLOGY DEV'S
  596. BK140172Blood Establishment Computer Software and Accessories
  597. K053485THERATRON EQUINOX, MODELS 80 CM AND 100 CM
  598. K2032853M Comply Hydrogen Peroxide Indicator Tape 1228
  599. K852230ANA/LITE-RL TEST SYSTEM
  600. K192905Creo Electrosurgical System with HS1 Hemostasis Accessory
  601. K111356ASIMANAGER - AT
  602. K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
  603. K972115VOLKER HOSPITAL BED, MODEL K960
  604. K240601SnapshotNIR model KD205
  605. K812357VENTREX DATA REDUCTION & QUAL. CONTR. SY
  606. K903198ALANINE AMINOTRANSFERASE TEST
  607. K222693Single-use medical latex examination gloves (LG100)
  608. K954402ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
  609. K152690DISPOSABLE THERMOMETER PROBE SHEATHS
  610. K841917SIGMS PROCED. 228 UV LACTATE DEHYDRO
  611. K080495SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
  612. K821250METRACO EVOKED POTENTIAL SYSTEM
  613. K933073HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
  614. K935472R & D BATTERIES, INC. PART NUMBER 5047
  615. K760914DOUBLE ELUTRA-PACK UNIT
  616. K834012SIM MEDIUM
  617. K852883MEDILOG M3
  618. K973705CONTOR TABLE SURFACE
  619. K192584BEACON Caresystem Model 00002144
  620. K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
  621. K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
  622. K891907QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
  623. K955892HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY
  624. K260382MONARCH™ Platform (MON-000008)
  625. K222651Surgical Face Mask
  626. K880890THE S.A.F.E. SYSTEM
  627. K790111ATOMIZER, FURNACE MODEL HGA-400
  628. K813073OMEGA 500 RECTANGULAR FIELD CAMERA W/SC
  629. K891275PATIENT EXAMINATION GLOVES (LATEX)
  630. K812409SPHYGMOMANOMETER
  631. K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
  632. K890711DUAL GRAPH (TM) RECORDER-MONITOR
  633. K880122MIDDLEBROOK 7H9 BROTH
  634. K861258PERMABAND (ORTHODONTIC ADHESIVE)
  635. K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)
  636. K040938RADIAL NAIL SYSTEM
  637. K902150PIEZO HANDPIECE
  638. K842721LIMONENE
  639. K192047Rampart™ One Lumbar Interbody Fusion System
  640. K983647ECHO-COAT ULTRASOUND NEEDLES
  641. K832889AMYLASE
  642. K011795WORLAND UNICONDYLAR TIBIAL BEARING
  643. K011364CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
  644. K951514SSC MODEL 4000 SERIES
  645. K903412STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.
  646. K112490QUIDEL MOLECULAR HMPV ASSAY
  647. K211647HP358EA Electrically Powered Wheelchair
  648. K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
  649. K952622CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
  650. K002313COMPLEXED PSA MICROTITER ELISA
  651. K123271ABBOTT PHENOBARBITAL ASSAY
  652. K771454MICRO SYRINGE & NEEDLE
  653. K961974FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
  654. K973035VIOLA II DENTAL CAMERA SYSTEM
  655. K141293PHOT-X IIS MODEL 505
  656. K890319URIC ACID KIT, CODES 4825400 AND 4825050
  657. K041328SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
  658. K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…
  659. K912796SPORE STRIP
  660. K841803A1 SYSTEME 8201/2
  661. K840466NML CORTISOL RIA
  662. K872456HEMOCOR PLUS HEMOCONCENTRATOR
  663. K853258BETA-HCG MICROTITER PREGNANCY TEST
  664. K211487MAF Guard
  665. K053304COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
  666. K970781LIQUID GLUCOSE (OXIDASE) REAGENT SET
  667. K041309IMASK TM
  668. K211665SONON Ultrasound Imaging System, Model: SONON300C
  669. K102822IMPLANT-ONE SYSTEM
  670. K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter…
  671. K950197MICROCO
  672. K922461COMFEEL WOUND DRESSING ORD
  673. K896572REP(TM) SPE PLUS-30 PROCEDURES
  674. K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
  675. K952937NIOMED NON-SKID SHOE COVERS
  676. K982849PANTHER WHEELCHAIR
  677. K130318NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
  678. K032767LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES
  679. K153705PROcedure Rehearsal Studio
  680. K222320MedDream
  681. K984315THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED…
  682. K023838LUNEAU STERILE TONOMETER SEPARATION PRISMS
  683. K984441KVO CHECK VALVE ACCESSORY, MODEL EV-0001
  684. K052009CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR
  685. K232218Zenius™ Spinal System
  686. K221599HS40 Diagnostic Ultrasound System
  687. K133239ZOLL E SERIES
  688. K171169Aquarius 8600 1417TG and Aquarius 8600 1717TG
  689. K182481HEM-6410T-ZM Wrist Blood Pressure Monitor
  690. K033078DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
  691. K003570BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
  692. K241819CephNinja
  693. K141250FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
  694. K203665STOP U Model UXV Device
  695. K011089SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY…
  696. K921700TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
  697. K000467URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
  698. K904049ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
  699. K894716DIRECTABLE COAXIAL CATHETER SET
  700. K241538TriClip Steerable Guide Catheter
  701. K182805RCT800
  702. K242996EndyMed PRO MAX
  703. K853367H-H BURR HOLE CATHETER SUPPORT
  704. K183166BacT/ALERT FA Plus; BacT/ALERT PF Plus
  705. K950033POLYDERM
  706. K190935EZER, Portable X-ray System
  707. K082195MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
  708. K142156SEEGENE ANYPLEX II HSV-1/2 ASSAY
  709. K9914103402 HANDHELD PULSE OXIMETER
  710. K233472CVAC Aspiration System + CVAC Image Processor
  711. K110525VITALOGRAPH MODEL 7100 - VITALOJAK
  712. K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
  713. K953025SLT 28MM XXL FEMORAL HEAD
  714. K101875BK BLANK MODEL 20,40,65,90
  715. K200969NEXXT MATRIXX System
  716. K062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
  717. K983090ACON MIDSTREAM PREGNANCY TEST
  718. K873684ACE INTRA COMPARTMENTAL PRESSURE MONITOR
  719. K142978Audit MicroControls Linearity LQ Special Diabetes
  720. K940396WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
  721. K202535Arthrex FastThread Interference Screw
  722. K922253KERATOREF L60
  723. K964071ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR
  724. K925820ARTHRITIC HEAT WRAP
  725. K013589CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
  726. K896533SPENCO BREAST FORMS
  727. K093599ARROW ANATOMICAL SHOULDER SYSTEM
  728. K9923263M CLINPRO SEALANT
  729. K884386ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
  730. BK210573Test, Qualitative, for HLA, Non-Diagnostic
  731. K925859READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
  732. K885135MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
  733. K874033IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
  734. K870025AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
  735. K041637TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
  736. K201941Monitor B125, Monitor B105
  737. K89290660 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
  738. K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…
  739. K823778GAMMA STERILIZED CAPILLARY FLOW DIALYZ
  740. K081300DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
  741. K871147MODIFIED CPREVIVER
  742. K960141G.E. STERILE, STANDARD BIOPSY TRAY
  743. K862358EPICATH
  744. K112320FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
  745. K203678CD HORIZON™ Spinal System
  746. K141042MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
  747. K990235D-SIGN VI (R&D PROJECT DW266#9)
  748. K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
  749. K150977CIRRUS HD-OCT
  750. K833418CHYMOFAST TEST
  751. K152813FS-500DDR Medical Radiographic X-Ray System
  752. K994187SYNTHES CERVIFIX SYSTEM
  753. K871183FLAME PHOTOMETER STANDARD #60082 140 NA/5K
  754. K870861UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
  755. K122078LOFRIC PRIMO, LOFRIC HYDRO-KIT
  756. K001255CD HORIZON SPINAL SYSTEM
  757. K771496CHEMCODE/CHEMTEK SYSTEM
  758. K133770A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
  759. K024223LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
  760. K891032ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
  761. K823316DENTAL INSTRUMENTS - FILES
  762. K922368PERIFLUX PF4001 LASER DOPPLER FLOWMETER
  763. K803032PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
  764. K152005MONTAGE Settable, Resorbable Hemostatic Bone Putty
  765. K852042BRIMFIELD CANNULATED BLADE HOLDER
  766. K171904Tandry Locking Plate System
  767. K192728Agnes
  768. K182242VO200 – NeurOs Cerebral Oximetry System
  769. K895419DISPOSABLE DISC FILTER
  770. K770142SMA REFERENCE SERUM 3
  771. K781156DIALYSIS SYS., PDS 400 & RO 400
  772. K813553PACE *AID
  773. K223916PUMA-G System
  774. K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
  775. K830477CARDIOMEMO III
  776. K812724RELAXATION TANK
  777. K900507DISPOSABLE SCREW TYPE PROPHY BRUSH
  778. K173911Medline Burn and Wound Dressing
  779. K844967ECHO TYPE 9 CF ANTIGEN
  780. K170169PRECICE Intramedullary Limb Lengthening System
  781. K230623KITE Distal Fibula Kit
  782. K261336Xpert Respiratory Panel
  783. K234028COPAL® exchange G hip spacer; COPAL® G+V
  784. K120896WI-FI BODY SCALE
  785. K950126ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE
  786. K910134OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)
  787. K070575EVICEL APPLICATION DEVICE
  788. K880588AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4
  789. K954133AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
  790. K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
  791. K853543DAVOL RETRIEVAL BALLOON CATHETER
  792. K151953A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
  793. K093635MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
  794. K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
  795. K220377Procedure Mask
  796. K863865TENSOTAPE SURGICAL ADHESIVE TAPE
  797. K020730ORION NASAL CPAP SYSTEM
  798. K903745THE HAYEK OSCILLATOR
  799. K905135LAPAROTOMY SPONGES
  800. K954581ARC SERIES
  801. K110017AG-608N BLOOD GLUCOSE MONITORING SYSTEM
  802. K915156I-125 SEEDS CODE: 6702
  803. K841741SINGLE HAIR TRANSPLANT GRAFT
  804. K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
  805. K191659Instylla Delivery Kit
  806. K800591CONTOUROGRAPH M-500
  807. K222128Protective Gown AAMI Level 4
  808. K192064LIAISON Vitamin B12
  809. K020452HIGH SILVER CONVENTIONAL
  810. K063527MBCP+
  811. K111213VISION ONE LASER SYSTEM
  812. K873038TECHTON PROTECTIVE PAD
  813. K993796RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE…
  814. K820362REUTER BOBBIN VENTILA. TUBE-TITANIUM
  815. K990123PVR-100/VASOGRAM
  816. K791449AGGLUTINOTEST-BRUCELLA
  817. K840481INFUSE-A-PORT HEPARIN LOCK MAINT KIT
  818. K992749ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
  819. K844702GAUZE ASORBABLE
  820. K854067SELECT FLOWMETER
  821. K100645AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
  822. K862820LADD/STERITEK ICP MONITOR, CAT. NO. P3000
  823. K170968PROPHECY INVISION Pre-operative Navigation System
  824. K052065ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
  825. K043048GRAFTON PLUS DBM PASTE
  826. K852495CAST-TECH CO. COOLING SYSTEM
  827. K262070Diode Laser Therapy Systems (DL612A)
  828. K132519STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
  829. K133903BIO-PROBE TRANSDUCER (ADULT)
  830. K223718HandX™ Self-Righting Needle Holder
  831. K813222MODEL 4200 ELLESTAD STRESS TEST ANALYZER
  832. K041122PRECISION LIQUID OXYGEN SYSTEM
  833. K112485H-WAVE
  834. K860063ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM
  835. K811521FUJI IONOMER TYPE I & II
  836. BK830020Container, Empty, For the Collection '& Processing of Blood/Blood Components
  837. K954137QBC CENTRIFUGAL HEMATOLOGY CONTROL
  838. K000691VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS…
  839. K852686SONOLINE CD
  840. K900141DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
  841. K961021KIRSCHNER KNEE MODIFIED
  842. K965058NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
  843. K181918CardioInsight Cardiac Mapping System
  844. K062686UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
  845. K923121QBC HEMACAN HEMATOLOGY SYSTEM
  846. K830329ESOPHAGEAL STETHOSCOPE
  847. K790290NEY EQUI-HINGE
  848. K151706Specular Microscope CEM- 530
  849. K100394MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
  850. K873175CENTRAL SUPPLY ROOM WRAP
  851. K100092CORVUS RADIATION THERAPY PLANNING SYSTEM
  852. K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
  853. K896531NOVADERM
  854. K982382COBAS INTEGRA REAGENT CASSETTES
  855. K860877FLEXTUBE, CONNECTING TUBING
  856. K945057PULPDENT HYBRID ANTERIOR COMPOSITE
  857. K003023COBE HC 700 MIDI HEMOCONCENTRATOR
  858. K811257CORNING 965 CARBON DIOXIDE ANALYZER
  859. K811918AMP MARK IV INFUSION PUMP
  860. K945124BREAST LESION LOCALIZATION NEEDLE
  861. BK150357Automated Blood Cell Separators
  862. K002783FIXION INTERLOCKING NAIL (FIXION IL NAIL)
  863. K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
  864. K990118ISOBAR SPINAL SYSTEM
  865. K864453EMERGENCY & MILITARY INFUSION SYSTEM
  866. K173707P200TE
  867. K103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND…
  868. K073555INSULIN PROTECTOR
  869. K875158ACS FUNNEL INTRODUCER
  870. K980578INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
  871. K933550HYDRASPUN M STERILIZATION WRAP
  872. K081248QUANTA LITE OMP PLUS ELISA
  873. K170889HV Screw System
  874. K111587ALERKAN SPIROMETRY FILTER
  875. K243641da Vinci Surgical System (IS5000)
  876. K041403ECLIPSE WITH AAA
  877. K940506ACUFEX ARTHROSCOPIC SUTURE CUTTER
  878. K203670Extra Large Check-Flo Introducer
  879. K151177XenMatrix AB Surgical Graft
  880. K791858CARDIOPLEGIA ADMIN. SETS
  881. K151158ALP VasQcare Take Home System
  882. K071141BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
  883. K930801INTROPEEL
  884. K821357MODIFIED NEURO SURGERY NIBBLING FORCEPS
  885. K143757ANUTRA Feedback Aspiration Syringe
  886. K860595TRANSFER SET
  887. K061356POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION…
  888. K031134DISPOSABLE POWDERED VINYL EXAM GLOVES
  889. K022533FASTPACK TESTOSTERONE CALIBRATOR
  890. K251227da Vinci Surgical System (IS5000)
  891. K253652Genie MAX Large Bore Introducer Sheath
  892. K232525Yoni.Fit Bladder Support
  893. K172570ALGS6 Ag Alginate Wound Dressing
  894. K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
  895. K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
  896. K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl…
  897. K251281Nova Max Creat eGFR Monitoring System
  898. K822959ENDOSCOPIC VIDEOSYSTEM
  899. K891387WILLIAMS BELT & BOOT
  900. K881605BIOPSY GUIDE
  901. K980824A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
  902. K970704PERSONAL CATHETER
  903. K843249T-TYPE IV EXTENSION SET
  904. K853655NEW JERSEY MODULAR FEMORAL HIP
  905. K936292PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
  906. K844004ESCHMANN TDB50 BIPOLAR COAGULATION
  907. K121008TRILLIANT SURGICAL K-WIRES
  908. K234116Trigon Trigon HA Stand-Alone Wedge Fixation System
  909. K193378CarboClear Lumbar Cage System
  910. K810573TUBE FEEDING SET
  911. K982063ALM PRISMALIX (PRX) SURGICAL LIGHT
  912. K1413110.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
  913. K153311Flexitouch System
  914. K092833ENDOMAX CORDLESS ENDODONTIC HANDPIECE
  915. K161582DORA Tubing Sets for Hemodialysis
  916. K920480DRESSING CHANG & WOUND MANAGEMENT
  917. K180459VERASENSE for Zimmer Biomet Persona
  918. K930530INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
  919. K872709MODEL 20-C, RL-20A/U, OB-10A/U
  920. K001070RADIOMED SOURCE
  921. K181544Anchor Bolt (as an accessory to Depth Electrodes)
  922. K031808MEDRAD SWABBABLE VALVE TRANSFER SET
  923. K862679MODIFIED SUPER MAXITHINS PADS, UNSCENTED
  924. K934959MODEL 118 FETAL/MATERNAL MONITOR
  925. K932318USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
  926. K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
  927. K053364HALUX IRIS EXAMINATION AND SURGICAL LAMP
  928. K011550HCG STAT PAK ULTRA-FAST
  929. K792178KODAK CFN FILM SO-224
  930. K993802SHARPVIEW IMAGE ENHANCEMENT SYSTEM
  931. K852236MEDTRONIC MODEL 5867-1A
  932. K780902FISHER SPECTROPHOTOMETER
  933. K942260ALDEN WHEELCHAIR CUSHION
  934. K885055INSU COOL
  935. K882965KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753
  936. K993176MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
  937. K090235ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
  938. K842582CARE 5000 CENTRAL MONITOR MS5220 ETC.
  939. K061960FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
  940. K240514AMT Low-Profile Suprapubic Catheter & Drainage Set
  941. K173531Lockbox for Perfusor Space PCA Infusion Pump
  942. K812123CYTOMEGELISA TEST KIT
  943. K891372ORTHODONTIC PLASTIC BRACKET
  944. K973569SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
  945. K101717DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H…
  946. K171299Fixone Biocomposite Anchor
  947. K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
  948. K894415DYMAX ENDOVAGINAL BIOPSY GUIDE
  949. K051415ENDOTINE RIBBON
  950. K872605HAND/FOOT UVA 624-218
  951. K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular…
  952. K021504TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
  953. K823828THERACARD 400
  954. K131555MEDSOURCE IV SAFETY CATHETER
  955. K833246TYMPANOSTOMY TUBES-VARIOUS
  956. K981088MILLS COLUMELLA PROSTHESIS
  957. K210663Dermatological Diode Laser Systems
  958. K022390HITACHI ALTAIRE
  959. K931231SIDEKICK II
  960. K875149PERIDONTAL SCALING SOLUTION-B
  961. K070195BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
  962. K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
  963. K912856MEDE-FLO I.V. EXTENSION SET
  964. K902995PC-BEADS POSTCOITAL TEST
  965. K934891AMPHETAMINES EIA ASSAY MODIFICATION
  966. K894111VARI-SET
  967. K163214Unicare System, Unicare Manipulator
  968. K852451RIONET HEARING AID HB-34HT
  969. K781831SPIROMETER, INCENTIVE CATALOG # 1750
  970. K811531RIONET HEARING AID HB-69
  971. K922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE
  972. K810006TOMOMATIC 64
  973. K172628PRECICE System
  974. K024089VACUFLASH BIOPSY SYSTEM
  975. K884325SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
  976. K1018184CIS VANE SPINE SYSTEM
  977. K913051SPECTRAL EEG MONITOR MODEL B500
  978. K212838Benchmark Intracranial Access System
  979. K930320AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
  980. K071361R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
  981. K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3…
  982. K254161Automated Aortic Stenosis Software (AutoAS)
  983. K871045DMI AMBULATORY HOLTER MONITOR
  984. K932552SPORTS MEDICINE QUADRATURE SHOULDER COIL
  985. K881069DISPOSABLE STERILE LATEX SURGICAL GLOVES
  986. K921848BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
  987. K230658SKOUT® system
  988. K9723553M AURORA SYSTEM
  989. K142777Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
  990. K870997SOLA UV GARD(TM) SUNGLASSES
  991. K902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
  992. K081878LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
  993. K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS)…
  994. K920452THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST
  995. K841130TRYPTICASE SOY AGAR W/5% SHEEP BLOOD
  996. K050767STERLING INTERFERENCE SCREW ST
  997. K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH…
  998. K191446Ureteral Stent Systems, Biliary Drainage Catheters
  999. K831237SPIROMED RESPIROMETER
  1000. K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing…

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