Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K002520ROVERS SPATULA
  2. K201149CoLink Plating System
  3. K190572Erchonia FX-635
  4. K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and…
  5. K151274Dr's Finder
  6. K910096ELECTONE BTE MODEL AM900 PP
  7. K900546BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
  8. K140851INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
  9. K082753FUTURABOND M/FUTURABOND M SINGLE DOSE
  10. K111877EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING…
  11. K160492Hospira Sapphire Sets
  12. K073520ANGIOTECH CVC
  13. K853758PY-RITE
  14. K010470R & D 4K RETIC
  15. K010518SYNTHES ANTEROLATERAL CALCANEAL PLATE
  16. K882090HIP SAVER
  17. K033061CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
  18. K924851STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
  19. K001369RESPIEVENTS, VERSION 4.2
  20. K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
  21. K903609SEROTONIN ENZYME IMMUNOASSAY
  22. K100324POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
  23. K935475QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
  24. K945903BRAINLAB MASK SYSTEM
  25. K003190EN BLOC BIOPSY SYSTEM
  26. K862434SUCTION T CONNECTOR
  27. K241700Tenex 2nd Generation System
  28. K000490CYNOSURE PHOTOGENICA VLS-STAR
  29. K874974PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER
  30. K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
  31. K212612Omnia Medical TiBrid-SC
  32. K973570QUICK CARD HCG ONE STEP PREGNANCY TEST
  33. K140852VECTRAPLEX CMS
  34. K983185BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
  35. K083328ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
  36. K771263RADIOMHTER OSM-2 HEMOXIMETER
  37. K883427VIRGO(R) VZV-IGG ELISA
  38. K842521AST/GOT REAGENT SET UV RATE
  39. K231335Cleerly ISCHEMIA
  40. K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
  41. K770628CLAMP BE-152
  42. K102382SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
  43. K142457Quickie, Zippie
  44. K900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
  45. K915758STREP A OIA
  46. K842563SERATEST DNA DETERMINATION
  47. K952708PECTORALIS IMPLANT
  48. K221366Smart Correction System Rings and Compatible HA-Coated Half Pins
  49. K232784RELiZORB®
  50. K771581STETHOSCOPE, NURSESCOPE TYPE
  51. K053115XIA SPINAL SYSTEM
  52. K973403CARDIOSMART ST
  53. K900765STEEROCATH(TM)
  54. K813149S/P VORTEX MIXER JR.
  55. K024303EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
  56. K932918TOTAL KNEE KIT
  57. K024233KOMPRESSOR SCREW SYSTEM
  58. K151981Turnpike catheter
  59. K900059BIOPOTENTIAL SURFACE ELECTRODE
  60. K970933AUTO HDL CHOLESTEROL CALIBRATOR
  61. K201182iMask Disposable Surgical Face Mask
  62. K143693MEDLINE SHARPS CONTAINERS
  63. K212583AlignRT Plus
  64. K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
  65. K852056ACC CROSS CYLINDERS
  66. K221084Dyna Locking Trochanteric Nail™
  67. K980418BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT…
  68. K792091BROWNE MODEL UD-4D
  69. K921467DRAKE & DRAKE/200 DL
  70. K863637UPDATED STERILE GOWNS, MASKS AND TOWELS
  71. K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
  72. K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
  73. K200725Citregen Tendon Interference Screw and Citrelock
  74. K092371SWIFT-LOCK ANCHOR, MODEL 1192
  75. K233811DT Controlled Phototherapy Equipment
  76. K900731MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)
  77. K902586GRI LASERGRAPH(TM) ECG PAPER
  78. K882216SYNCOR (R) MODEL S-801 ECG ELECTRODE
  79. K192358Pressure Therapy System PT1003
  80. K781132CHEMLAR
  81. K871330EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
  82. K883416MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)
  83. K925016PREP SHAVE KIT (NON-STERILE)
  84. K864875ELECTRA AUTOMATIC SAMPLER
  85. K051288VIELLE LUBRICANT
  86. K253922Neodent Scannable Healing Abutment
  87. K896844BABE-EASE NEONATAL CLOTH ECG ELECTRODE
  88. K963902QUANTITATIVE FIBRINOGEN ASSAY
  89. K812848ACCRA LAB HEMOTOLOGY
  90. K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…
  91. K881905MODEL MICRO SI AMBULATORY ECG MONITOR
  92. K770780REAGENTS
  93. K220471VALO X, VALO X Accessory Lenses
  94. K050414PLIX
  95. K974616SINGER ACUPUNCTURE NEEDLES
  96. K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
  97. K893545IVEX MODEL NO. BP 3000 BREASTPUMP
  98. K081196SPINAL USA VBR SYSTEM
  99. K250350Thrive 2-in-1 Breast Pump (Model P3)
  100. K250385Turbo-Elite Laser Atherectomy Catheter
  101. K150460KYPHON (R) HV-R(R) Bone Cement
  102. K961442UNIVERSAL DRAINAGE TRAY
  103. K910222COBAS ALPHA
  104. K962485OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
  105. K951317PHENO-CEN SPRAY DISINFECTANT DEODORANT
  106. K940810CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
  107. K052861MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
  108. K893772TISSUE EMBEDDING MEDIUM
  109. K163398ATLANTIS suprastructures
  110. K230115Denture Base Resin
  111. K880351VITAL SYSTEM
  112. K131939AMICO DH-W35 OPHTHALMOSCOPE SERIES
  113. K880487NEOTECH MECONIUM ASPIRATOR (STERILE)
  114. K860898SUBCLAVIAN INTRODUCER SET
  115. K113713GEN_2 MECHANICAL WHEELCHAIR
  116. K050867SYNGO BODY PERFUSION-CT
  117. K203570Mya Joy PLUS Breast Pump
  118. BK890019Supplies, Blood-Bank
  119. K973414ACE PHENYTOIN REAGENT, AED CALIBRATORS
  120. K921460STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
  121. K022636BODY BOX 5500
  122. K990526KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
  123. K980489VAPAMASTA 6
  124. K093508RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
  125. K940201PRESTIGE FRAMES
  126. K924748VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
  127. K181457EndoStream(TM)
  128. K770152AUTO-RINSE
  129. K031357GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM…
  130. K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…
  131. K112918DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
  132. K832648ACCLAIM
  133. K844263MODEL 493-01 PACING LEAD
  134. K033580NEXFLEX TOTAL HIP SYSTEM
  135. K201793EDEN Peek Cage
  136. K0726973T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
  137. K900579AUTOREADER CALIBRATION TEST PLATE
  138. K893215VITAJET(INSULIN JET INJECTION DEVICE)
  139. K830568GUTTMAN INFUSION NEEDLE
  140. K902091SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
  141. K831684CYNOMOLGUS MONKEY KIDNEY CELLS SV5
  142. K002854GOLD CORE POST SOLDER
  143. K832719EMIT AED VALPROIC ACID ASSAY
  144. K911252PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
  145. K932536CARDIOMETRICS FLOWIRE & FLOMAP
  146. K071834STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
  147. K840850ANESTHESIA VENTILATOR CIRCUIT
  148. K896867THYROID STIMULATING HORMONE-EIA-XT
  149. K901501CORPAK GASTROSTOMY TUBE
  150. K992151REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
  151. K232115TDM Large Bone Plate and Screw System
  152. K904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
  153. K072194RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
  154. K083659SILVER WOUND PAD
  155. K040788CALM PATTERNS, VERSION 01.00.00
  156. K895060750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
  157. K964541SANPO I
  158. K9141142DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
  159. K120730LOUTREX TOPICAL CREAM
  160. K834576REAL FIBER OPTIC URETERAL TRANSILLUMIN
  161. K780834PREVI DENT PROPHYLAXIS MINT NDC
  162. K173863Ez3D-i /E3
  163. K251981Boston PICO (Boston PICO)
  164. K974510ENVOY PATIENT MONITOR
  165. K913094DISPOSABLE SLIDE VALVE MANIFOLD
  166. K790923MI-MARK ENDOCERVICAL SAMPLING SET
  167. BK960052Blood Establishment Computer Software and Accessories
  168. K050085OSTEOPAL V
  169. K160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
  170. K810094DENTURE RUBBER BASE MATERIAL
  171. K863091BICORD BY QMED
  172. K974381CANDELA GENTLELASE GL DERMATOLOGICAL LASER
  173. K950989CARDIOSMART
  174. K861408MODIFIED UNISCEPT KB LABELING AMENDMENT
  175. K062041MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
  176. K170432Anprolene AN75 Ethylene Oxide Gas Sterilizer
  177. K100821PREVENA INCISION MANAGEMENT SYSTEM
  178. K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
  179. K841377CREATININE - A.A.S.
  180. K860320GRANULOCOLOR
  181. K002470M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
  182. K962814DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
  183. K800792ADJUSTABLE HEAD & FACE HOLDER
  184. K941506URETERAL ILLUMINATOR
  185. K070299EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
  186. K110644PRAEZIS PLUS
  187. K011380MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
  188. K896750LOFRIC(R), LOFRIC(R) CATH-KIT
  189. K973688DUODERM CONTROL GEL FORMULA BORDER DRESSING
  190. K061756TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
  191. K141695ACROSSPINE PEDICLE SCREW SYSTEM
  192. K252751Earflo (EF001)
  193. K801935PAD, HOSPITAL STRETCHER
  194. K944783SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES
  195. K884170ANALYST THEOPHYLLINE CALIBRATOR
  196. K962199QUANTEX C3
  197. K140711COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG…
  198. K833375DUAL PURPOSE CATHETER
  199. K841955DUPONT ACA MAGNESIUM CALIBRATOR
  200. K945108POLY PISTON
  201. K233245MagnetOs Flex Matrix
  202. K060809OSTEO-LINK BONE VOID FILLER PELLETS
  203. K163453VitalPatch® VitalConnect Platform
  204. K142851CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
  205. K231446Single-Use Latex Sterile Surgical Gloves (SG100)
  206. K981407OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
  207. K801584MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
  208. K891223PATIENT EXAMINATION GLOVES (LATEX)
  209. K872159DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
  210. K993063RUSCH BRILLANT SILICONE FOLEY
  211. K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
  212. K202826IMMULITE® 2000 Cortisol
  213. BK940011Blood Establishment Computer Software and Accessories
  214. K090386NON-INVASIVE INFRARED (NIR)
  215. K781207DOUCHE KIT, SOMETHING PERSONAL
  216. K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…
  217. K854117AMENDMENT LIFEPAK 8, NPN 052
  218. K935548CATHEJELL S STERILE LUBRICATING JELLY
  219. K842805IMPULS 3, IT SELECTOR
  220. K261741Hemostatic Clip
  221. K123253IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS…
  222. K101838VTS1000
  223. K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
  224. K091973METASUL TAPER LINERS, METASUL FEMORAL HEADS
  225. K220220Electronic Sphygmomanometer (Model: LT-P30)
  226. K874241OPMI MD SURGICAL MICROSCOPE
  227. K812971CARDIOINTEGRAM
  228. K041886PROVISO
  229. K913404IMPLANDRILL - THREADED DENTAL IMPLANT
  230. K021023HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
  231. K935091ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE
  232. K061411TORBOT VASCULAR COMPRESSION GARMENTS
  233. K102001MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
  234. K811809ANTI-ARRHYTHMIC CONTROL LEVELS I & II
  235. K082297BUSSE SURGICAL DRAPE
  236. K123246CD HORIZON SPIRE Z SPINAL SYSTEM
  237. K862380MATTRESS COVER
  238. K842760LUNG ANALYZER CM-310
  239. K212418hCG One Step Pregnancy Test
  240. K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE…
  241. K770589FILTER, INTRAVENOUS W/AUTO AIR VENT
  242. K983550XYZ SYSTEM
  243. K991819MAGNATEK 30
  244. K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR…
  245. K972789ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
  246. K102603SA FLOWABLE ADHESIVE
  247. K212114Elekta Unity
  248. K771225AP ISOTROL, #A 0140
  249. K874898CM 3000 THE MONITOR
  250. K180135THD Anopress with THD SensyProbe
  251. K940636CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
  252. K882197MINIMON 7131B PATIENT MONITOR
  253. K180875POLY REJUV
  254. K931679BUTTRESS PLATE
  255. K863470DALTEX IV INFUSION PUMP
  256. K972512SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
  257. K895681CONTRAST BACKGROUND MATERIAL
  258. K072220PEDI CO2 EASY
  259. K923035MILES URINE UREA NITROGEN METHOD
  260. K051045SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
  261. K864050TUBULICID BLUE LABEL
  262. K091722COAXIAL APPLICATOR SYSTEM
  263. K820948THREE SECOND THERMOMETER #TS-1000
  264. K864248MUELLER HINTON AGAR - SUPPLEMENTED
  265. K041017SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
  266. K961166FLOWTRON EXCEL PUMP
  267. K171748Vitrification Kit and Thawing Kit
  268. K073068ACCIN HIP SYSTEM
  269. K881544LITTMAN AGAR
  270. K971333SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL…
  271. K071118GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND…
  272. K110271MAESTRO WRIST PLATING SYSTEM
  273. K914784PAPILLION PROCTOSCOPE
  274. K897063FUKUDA DENSHI MODEL DS-3300 ETR
  275. K834357ANA TRANS TUBE & SWABS STERILE PACK
  276. K100365FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
  277. K911456MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
  278. K932436ECHOMARK INTRAUTERINE GUIDING CATHETER
  279. K032368SONOMA ANTERIOR CERVICAL PLATE SYSTEM
  280. K980813RELIANCE LONG STEM FEMORAL COMPONENTS
  281. K153549OSSIX VOLUMAX
  282. K030447AT HOME DRUG CUP, MODEL 9150X
  283. K780491DATA CAMERA
  284. K221068Sterile Hypodermic Syringes for Single Use with Needles
  285. K801373BECKMAN MODEL 42 SPECTROPHOTOMETER
  286. K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
  287. K933846ANGIOGRAPHY SYRINGE KITS
  288. K940957HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
  289. K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
  290. K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular…
  291. K983145TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM…
  292. K974578GREPAFLOXACIN, 5 MG, SENSI-DISC
  293. K863929TERUMO SENSIBEAD(TM) EIA HLH KIT
  294. K254153Single-use Video Scope; PB Digital Controller
  295. K202418Magic UCLA Abutment System
  296. K090518QUART ARTERIAL FILTER WITH SOFTLINE COATING
  297. K213757Endocem MTA Premixed Regular
  298. K991960SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS…
  299. K112717NUVASIVE NVJJB SYSTEM
  300. K172850SterilContainer with PrimeLine Pro Lid
  301. K905836ULTRA WAVE 101
  302. K253560Enhanced Boundary for PCCT
  303. K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
  304. K040628PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
  305. K252962DYNAMIS™ Navigation System
  306. K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
  307. K830321VENTURE II MONITORING SYSTEM
  308. K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…
  309. K850288HEPATIC PARENCHYMAL SUCTION DISSECTOR
  310. K050866CENTRION 500 C-ARM SYSTEM
  311. K230377CROSSLEAD Penetration Peripheral Guide Wire
  312. K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
  313. K924969PHOTOTHERAPY TIMER
  314. K021644PERF (OMMAYA STYLE) RESERVOIRS
  315. K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
  316. K891246PATIENT EXAMINATION GLOVES (LATEX)
  317. K935245EPIDURAL ANESTHESIA TRAY
  318. K050937TRABECULAR METAL ACETABULAR REVISION SHELLS
  319. K122845ES2 SPINAL SYSTEM MODEL 48280XXXX
  320. K911661ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
  321. K850347API UNISCEPT KB
  322. K921613STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510
  323. K843028TOTAL PROTEIN ASSAY KIT
  324. K153407Stryker Neptune 3 Waste Management System
  325. K041607QUINTON Q-TE; RMS
  326. K172968Hair Up
  327. K110529ENDOFLIP GASTRIC TUBE
  328. K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
  329. K212419Magnifico Open, Magnifico MSK
  330. K232431syngo.CT Brain Hemorrhage
  331. K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
  332. K052605EXTERNAL FIXATION
  333. K882409PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
  334. K110362VANGUARD ASYMMETRICAL PATELLAR COMPONENT
  335. K883400OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
  336. K001725HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
  337. K953131EXUSORB STERILE ABSORBENT
  338. K222743Route 92 Medical Full Length 070 Access System
  339. K132322NEWTRON P5 XS B.LED
  340. K172925Contact Lens Case, Model: A-1, B-1
  341. K772377HILDYARD POST NASAL FORCEP
  342. K030957PERFECT CAPSULE
  343. K880801SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
  344. K840408LINEAR ARRAY TRANSDUCER OR SCANHEAD
  345. K981667HYDROPHILIC COATED GUIDEWIRE
  346. K150600Response 5.5/6.0 Spine System
  347. K896787TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
  348. K803051FLAME PHOTOMETRY REAGENTS
  349. K833978OMEGA 5000
  350. K101522ULTRA SEAL STERILE LUBRICATING JELLY
  351. K010457ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
  352. K853635SUBDERM TM
  353. K971501SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
  354. K120796SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
  355. K963674LUMEX AIR
  356. K052375ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
  357. K171365Arthrex Knee Systems
  358. K882488CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
  359. K112544UNIMED BLOOD PRESSURE CUFF
  360. K920915CAPNOMED 100 STAND-ALONE ETCO2 MODULE
  361. K922195OSTEO FEMORAL NAIL
  362. K250658SureFine Pen Needle
  363. K203256Imbio RV/LV Software
  364. K831140DADE HEMATOLOGY CALIBRATOR
  365. K062641BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
  366. K171738Supria True64
  367. K100794FLUORCANASITE DENTAL CERAMIC
  368. K812039SPIROMETER 210/211
  369. K811017HUCKSTEP INTRAMEDULLARY NAIL
  370. K953550CO2 ARTHROFLATOR
  371. K980953ACCU-BITE HOME KIT DISCLUDER
  372. K885071COAT-A-COUNT METHAMPHETAMIN #TKMA1
  373. K122445AESPIRE 7900, AESPIRE VIEW
  374. K852019BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD
  375. K781158ALARM UNIT, BATTERY OPERATED
  376. K881596FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
  377. K171193Certa Catheter
  378. K993279QSC-085 SHOULDER ARRAY COIL
  379. K991460MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
  380. K161688Advanced Gynecological Applicator
  381. K884433TECHNICON ASSIST(R) CALCIUM METHOD
  382. K161982C-Reactive Protein Kit for use on SPAPLUS
  383. K223672Instrument Case P1340904
  384. K943451ULTIMAX POWDER FREE EXAMINATION GLOVES
  385. K955363INCSTAR HSZ I/II IGG ELISA ASSAY
  386. K111135PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
  387. K990396T-ANASTAFLO
  388. K761035SURGICAL BLADE HANDLES
  389. K860775MEDIASTINAL AUTOTRANSFUSION SYSTEM
  390. K874224BIO-COR II COLLAGEN CORNEAL SHIELD
  391. K801521CLASSIC TAN TANNING BOOTH
  392. K072834SIBEL SA VASCULAR CLAMP
  393. K974706AESCULAP ABC CERVICAL PLATING SYSTEM
  394. K252361AccurECG Analysis System (v2.0)
  395. K911629SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
  396. K043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
  397. K860804MEDICAL ADHESIVE TAPE
  398. K220142BRM Digitalis Spacer
  399. K040667XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008…
  400. K821633VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
  401. K17089927HJ713S
  402. K890851PATIENT EXAMINATION GLOVES (NON-STERILE VINYL)
  403. K093596LUMOS, MODEL R 72B
  404. K232456RW-1
  405. K221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the…
  406. K905421EXIT ALARM
  407. K962210BACTEC 9050 SYSTEM
  408. K083812REFRESH OPTIVE LENS COMFORT REWETTING DROPS
  409. K801427TISSUE-TEK III MINI-RAPID PROCESSOR
  410. K991591BIOTHANE PATIENT RESTRAINT
  411. K932336NU-GEL ISLAND WOUND DRESSING
  412. K942635MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
  413. K193024Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint…
  414. K191422Neural Navigator
  415. K980616PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
  416. K802064DUPONT ACALACTIC ACID (LA) TEST
  417. K211341Blue Nitrile Exam Gloves
  418. K961632MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
  419. K163713Sofia Lyme FIA, Sofia Lyme Control Set
  420. K210282WIRION Embolic Protection System
  421. K053027VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
  422. K873242BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM
  423. K072672SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
  424. K851467HEMOGLOBIN ANALYZER
  425. K151400Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
  426. K052553NITOM LOCKING FACEBOW
  427. K193616ARIX Ankle System
  428. K000158VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
  429. K083915ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
  430. K791868OXIMETRIX SHAW HEMOSTATIC SURG. SYS.
  431. K880548SAFE-STRIPS
  432. K781982INCLINOMETER, VERMONT
  433. K831496ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
  434. K903308TRANSTAT-CMV(TM)
  435. K031780VERTE-STACK SPINAL SYSTEM
  436. K232308Monarch Blood Collection Set
  437. K854129ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
  438. K960137SAS SALMONELLA H Z10 ANTISERUM
  439. K770238OVERDOSE KIT
  440. K970948800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES
  441. K854613SURGICAL DRAPES, OPHTHALMIN
  442. K780714PLATELET CONTROL
  443. K861422PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
  444. K881914COVER UP
  445. K965107MEDLINE ADMISSION KITS
  446. K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…
  447. K873994EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
  448. K894459ANGIOSCOPE
  449. K971063OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
  450. K822885HALO TRACTION CERVICAL IMMOBILIZATION
  451. K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
  452. K871603CRITERION II & IIA OXYGEN CONCENTRATORS
  453. K823491BIRT-A-SWITCH DSP #712
  454. K222671DeltaScan Patch
  455. K862861SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
  456. K020884EXCELLITE LIGHT CURE UNIT
  457. K032975JMS BLOOD TUBING SETS
  458. K213907CareGUARD Sterilization Wrap
  459. K251715FlowArt® Vial Access Device Vented
  460. K961513PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET
  461. K050310BARDPORT TITANIUM PORTS
  462. K230236Lyra Influenza A+B Assay
  463. K864163HALL DUNBAR DRILL GUIDE SYSTEM
  464. K962755STRYKER ENCORE STERILIZER
  465. K862997PORTABLE ISOKINETICS 3005 HIP UNIT
  466. K070613ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
  467. K963749HIGH PRESSURE INJECTION LINES
  468. K211354Disposable Synthetic Vinyl Nitrile Examination Glove
  469. K023140VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
  470. K083070TOGGLELOC SYSTEM
  471. K103817POSEY BED
  472. K052828DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
  473. K120406ZOLL FULLY AUTOMATIC AED PLUS
  474. K250781Embryo Predict
  475. K003184RS BIOTECH GALAXY 'R' CO2 INCUBATOR
  476. K133530NUVASIVE EMG ENDOTRACHEAL TUBE
  477. K170553Altus Spine Interbody Fusion System
  478. K771074NASAL OXYGEN CANNULA, #017207
  479. K931561TROCAR SLEEVE
  480. K853651COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
  481. K182287MEDINAUT Plus
  482. K23372428mm/38D MDM X3 Insert for MDM Liner
  483. K821888AUTOMATIC SINGLE CHANNEL ECG #399
  484. K842845BONE MILL BONE GRINDER
  485. K061092BAXTER DUPLOSPRAY MIS APPLICATOR
  486. K881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
  487. K200920Idys ALIF ZP 3DTi
  488. K894608MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
  489. K932893VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
  490. K926513MOLLER-WEDEL OPERATING MICROSCOPE
  491. K000794MODIFICATION TO MARSPO2, MODEL 2001
  492. K170748GLOBAL UNITE Platform Shoulder System
  493. K000476MODIFICATION TO CD SPINAL SYSTEM
  494. K901719KLEIN MICRO-CANNULA HANDLE(TM)
  495. K830629COBE RX METER
  496. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
  497. K963151MEDI-TRACE 5700 RESTING ECG ELECTRODE
  498. K954824PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
  499. K922005GRANULYTE DIALYSATE CONCENTRATE
  500. K032133BRODA MODEL 587 MANUAL WHEELCHAIR
  501. K803058SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
  502. K110617MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY…
  503. K905205DW 235
  504. K863898MULTILITH 3 MODELS 1350, 3350, 1370, 3370
  505. K831088MINI-VOL I.V. SET
  506. K033381DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE…
  507. K827792SIREMOBILE 3
  508. K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
  509. K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
  510. K061531SPACE CPSXL BONE CEMENT
  511. K001572NEOLUS NEEDLE
  512. K982769MITRA IMAGING INC. EXHIBIT
  513. K911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
  514. K944282LASER DELIVERY PROBE
  515. K210712Verifine Mechanical Safety Insulin Syringe
  516. K904498CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
  517. K960737MODEL 555 010 XY CONVERSION(55010)
  518. K823497WRIGHT CARE
  519. K060554CMA CEREBRAL TISSUE MONITORING SYSTEM
  520. K230704RAIN Sheath™ Tibial Pedal Introducer
  521. K901265COULTER MAGNESIUM REAGENT
  522. K110555ARCOMXL ACTIVE ARTICULATION
  523. K223329Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
  524. K915683REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
  525. K124052OSTAVI HYDROPHILIC GUIDEWIRE
  526. K875015TRACETS 3000
  527. K022333SPIFE LIPPOROTEIN-12, MODEL 3344
  528. K051201E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY
  529. K900089FG DIAMOND BURRS
  530. K982634DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
  531. K032030BLINK CL LUBRICANT EYE DROPS
  532. K851573ABBOTT PHARAMACOKINETICS SYSTEMS
  533. K222620Sterilized Latex Surgical Gloves
  534. K220831Dental Implantation Systems, Dental Electrical Motors
  535. K210874Reliance Spinal Screw System
  536. K812915MX 125
  537. K192763syngo.CT CaScoring
  538. K112496PIONEER CROSSFUSE II IBF/VBR SYSTEM
  539. K780655STERILE INFUSION SET TYPE S
  540. K802919ISO-BAC INSTRUMENT WRAP
  541. K820737PERISCOPE VOICE PROSTHESIS
  542. K880968MODEL 2001 PHACOEMULSIFIER ASPIRATOR
  543. K811171VASCULON II I.V. CATHETER
  544. K191350ACTIVE® Free Testosterone RIA
  545. K162759KeraStat(R) Gel
  546. K133544OP300
  547. K021725DISETRONIC D-TRON INSULIN INFUSION PUMP
  548. K924451INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
  549. K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
  550. K883463HOSPITAL BED CLOTHING CRADLE
  551. K050857BIB PTA BALLOON CATHETER
  552. K870463DEFINED FETAL BOVINE SERUM #A-1111
  553. K860784DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
  554. K123967CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
  555. K850026ORTHOPEDIC IMPLANT NAILS & PINS
  556. K041624PTCA STEERABLE HYDROPHILIC GUIDEWIRE
  557. K071767DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
  558. K960202G.E. STERILE PUNCTURE TRAY
  559. K223419Triever16 Curve
  560. K200976SR-8230, SR-8230S Portable X-ray Unit
  561. K021396DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
  562. K021697GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
  563. K210475EQ-M
  564. K945998CHIN IMPLANT STYLE I
  565. K260597VIRTUE QA
  566. K831212ENDOSCANN
  567. K100120ALEXIS ORTHOPAEDIC WOUND RETRACTOR
  568. K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…
  569. K771655CURITY PEAKOMETER
  570. K243356Asiga DentaBASE
  571. K230614Cortium™
  572. K072534BIO-MAT 2000
  573. BK050013Blood Establishment Computer Software and Accessories
  574. K992948MAC-LAB SYSTEM
  575. K981305OLYMPUS SERUM PROTEIN MULTICALIBRATOR
  576. K973933SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
  577. K031787SMITH & NEPHEW IUR MORCELLATION SYSTEM
  578. K931238ENDOPATH DISPOSABLE KNOT PUSHER
  579. K212556mi-eye 3 needlescope with cannula, mi-tablet 3
  580. K854171I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
  581. K093710THE MOSES APPLIANCE
  582. K902755.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
  583. K130929ZMED VP4000
  584. K120091R&D INNOVATION PEDICLE SCREW SYSTEM
  585. K901458NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP
  586. K925364MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
  587. K230672Annabella Breast Pump
  588. K253181SURGIMAGE SIM 1000H Fluorescence Imaging Platform
  589. K222351inspired™ VHB20 Heated Humidifier
  590. K926378THERMABOND V
  591. K924191TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
  592. K854566TERUMO SURFLO ETFE I.V. CATHETER
  593. K212846Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle…
  594. K971590TACTYLON CONDOM
  595. K043578THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
  596. K828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC
  597. K140045BODY COMPOSITION ANALYZER
  598. K812030KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
  599. K011910IN-FAST BONE SCREW SYSTEM
  600. K011354HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
  601. K935508ARGEDENT 78PF
  602. K032248PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
  603. K915672EDWARDS ADJUSTABLE CONNECTORS
  604. K812711STERILE GAUZE PADS 12PLY
  605. K972737CAUSSE PISTON
  606. K063660OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
  607. K202056Kinepict Medical Imaging Tool 4.0
  608. K863329ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
  609. K850950VISION POTASSIUM
  610. K972563LIFT MASTER
  611. K062348TIMESH SELF DRILLING SCREW
  612. K892727IFA SENSIBAC INIPENEM
  613. K893431AUDITORY TRAINER PE150R FM RECEIVER
  614. K230461Quantra Hemostasis Analyzer
  615. K935150SONIPLAK
  616. K944417ZEUA MYCOPLASMA
  617. K832533SELENITE CYSTINE BROTH
  618. K971257VTU-1 VACUUM ERECTION SYSTEM
  619. K860271BIOFEEDBACK MICROLAB
  620. K963187MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30…
  621. K922736KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
  622. K991754GO GLUCOSE MONITORING SYSTEM
  623. K945261PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM
  624. K803252MICROMEDIC REAGENT DISPENSER
  625. K110463PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
  626. K260487stentFIX System Set (100.50n)
  627. K946083FLUTTER(R)
  628. K212364BLT Dental Implant System
  629. K110198BLUE SKY BIO TCP
  630. K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
  631. K894500DAIG ELECTROPHYSIOLOGY CATHETER
  632. K801710BK-5315-01 FOAM HAND EXERCISER, SMALL
  633. K810791PENTAX COLONOSCOPE MODEL FC-34 MA
  634. K843514MINUTEMAN CO2 MICROSURGICAL LASER OTO
  635. K022522PULPDENT PUTTY DAM
  636. K931968CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
  637. K823449RESPIRATORY GAS ANALYZER
  638. K042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
  639. K982824X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID
  640. K043126ASSIST HEADER CLEANER
  641. K823441AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
  642. K820393ANESTHESIA VENTILATOR
  643. K093476AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120…
  644. K900871ALTERNATING PRESSURE PUMP AND PAD SYSTEM
  645. K102016PRECICONTROL CLINCHEM MULTI 1 AND 2
  646. K193515Mako Total Knee Application
  647. K061405APNEALINK, MODEL 22302
  648. K040656MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
  649. K926287EXERCISE BICYCLE
  650. K897051MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH
  651. K041416EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
  652. K070114CREATION CP-ZI PORCELAIN
  653. K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230…
  654. K221048Episealer Patellofemoral System
  655. K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
  656. K891122DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.
  657. K213232NovaCore Semi-Automatic Biopsy Instrument
  658. K844612ACUTE HEMODIALYSIS TRAYS
  659. K943372CALCIUM HYDROXIDE PASTE
  660. K130851CASCADE HEMODIALYSIS/APHERESIS CATHETER
  661. K033735VANTAGE PRO ATTENUATION CORRECTION DEVICE
  662. K951994OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
  663. K013615MICRO-INDUCTION 1000 SYSTEM
  664. K851496ECG MONITOR MODEL RM102
  665. K100788COCR RODS
  666. K062880SUBDERMAL WIRE ELECTRODE, MODEL SWE
  667. K200051PUGGLE Enteral Feeding Pump and Feeding Set
  668. K964172MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
  669. K781241UNISTAT BILIRUBINOMETER
  670. K092488DYNAREX STERILE LUBRICATING JELLY
  671. K843529ASTRA SYSTEMS AMYLASE REAGENT KIT
  672. K842717COBAS-FIBRO
  673. K843110ROCHE STANDARDS FOR CHOLESTEROL
  674. K2538000909FCE, 0909FCE-HS
  675. K041906EXACTECH 12/14 TOTAL HIP SYSTEM
  676. K110087CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
  677. K936225TS1 TURTLE(TM) SYRINGE
  678. K942866CLINICAL BLOOD GAS MIXTURE
  679. K893777ALBUMIN TEST (ALB) ITEM NUMBER: 65401
  680. K863322MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS
  681. K851995ALT (ALANINE AMINO-THRANSFERASE)REAGENT
  682. K781311ELECTRODE, NEEDLE, CFM
  683. K840421ULNAR NERVE PROTECTOR
  684. K02159996 CHANNEL EEG HEADBOX MODEL EMU96
  685. K850291MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
  686. K001089POLYMACON
  687. K121555CENTURION VISION SYSTEM
  688. K080256PULMODYNE CHF FLOW GENERATOR SYSTEM
  689. K864812DIASONICS SPA 3.5 MHZ, 30MM PROBE
  690. K171232PeriView FLEX
  691. K033644ENDOBOY
  692. K061427PRE-IMPRESSION CONDITIONING SOLUTION
  693. K170916Portable Nebulizer
  694. K253607UNEEG EpiSight System
  695. K943495DISPOSABLE ESOPHAGEAL STETHOSCOPE
  696. K921632INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK
  697. K993725GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM…
  698. K852815TRIPLE LUMEN RIGHT ATRIAL CATHETER
  699. K875057FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
  700. K052962OPTIMIZED BARB DESIGN
  701. K172757Valleylab FX8 Electrosurgical Platform
  702. K071611NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
  703. K033736MERCI RETRIEVER, MODELS 90065, 90066
  704. K003644EYETECT TREMOR MONITOR UNIT (TMU)
  705. K201348DePuy 3D Additive TriFlange Acetabular Cup
  706. K954190MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
  707. K993957DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
  708. K001300D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
  709. K072283DORADO PTA BALLOON DILATATION CATHETER
  710. K050292SHARPOINT LUKENS BONE WAX
  711. K050309PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
  712. K810639SERALYZER SYSTEM
  713. K111178JUELL SOFT CURE
  714. K850963DUPONT PREP TYPE SI EXTRACITON CARTRIDGE
  715. K894642SLEEPAP MASK
  716. K151952Synergy ODM
  717. K981657PHILIPS THORAVISION
  718. K211845Deploy Expandable Interbody System
  719. K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
  720. K990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
  721. K823803RIONET HEARING AID HB-32P
  722. K940061POLYMEDIC SPINAL NEEDLE AND INTRODUCER
  723. K122247LIDCORAPID V2 MONITOR
  724. K811199MARZ-175
  725. K150449LITe Plate System
  726. K123585SYNGO, CT CARDIAC FUNCTION
  727. K041855PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
  728. K970306MARKMAN TEMPLATE SYSTEM
  729. K150033Air Compressible Limb Therapy System
  730. K943469SONICATOR 730
  731. K231203Mosie Baby Kit
  732. K173066OSSEODUO Shaver and Drill System
  733. K863879NEOS-M VS-1 PULSE GENERATOR
  734. K960567HF MEGA EAR
  735. K893874FUJITENS III
  736. K862464SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
  737. K924669FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W
  738. K931373ANALYZER: STAT PROFILE PLUS 10 ANALYZER
  739. K123526CLEARREAD +CONFIRM
  740. K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
  741. K834571FIBRINOGEN TEST
  742. K111674ACUSON
  743. K040041NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
  744. K874940CALIBRATION REFERENCE PLASMA
  745. K250128Single Use Suction-Evacuation Ureteral Access Sheath
  746. K011076LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
  747. K192029Straumann PUREloc abutments
  748. K813181ELECTROC-GYM
  749. K101643MODEL LTV 1100 VENTILATOR
  750. K991612STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
  751. K821615VAST VENTREX PD IGE RIA TEST SET
  752. K770059ORTHOPEDIC SPECIALTIES
  753. K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
  754. K870903IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM
  755. K090130ATMOS S041 WOUND
  756. K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
  757. K132778GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
  758. K791980TOME'S #'S 1221,1222,1223,1314,6640,6642
  759. K884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
  760. K923394MENLO CARE AQUASTENT SET
  761. K991585BIPOLAR SHOULDER PROSTHESIS
  762. K843042VISION TESTER
  763. K191115RS85 Diagnostic Ultrasound System
  764. K172575BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
  765. K122756PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
  766. K232755Arthrex FiberTape and TigerTape Cerclage Sutures
  767. K142511U50 Diagnostic Ultrasound System
  768. K060470ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL…
  769. K243164INDIBA COMPACT devices
  770. K862289KOREAN GREEN CROSS SCALP VEIN SET
  771. K833754HAMILTON PEDIATRICS SCALE
  772. K032158XIVE DENTAL IMPLANT SYSTEM MULTIPLE
  773. K861409SYNCARE TEMPORARY CARDIAC PACING WIRE
  774. K821642WHEEL CHAIR ACCESSORIES
  775. K951692MIST ENDOSCOPIC PROBES
  776. K874014OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)
  777. K032500MODIFICARION TO WACKERS-LIU CQ SOFTWARE
  778. K050136REPROCESSED HOT BIOPSY FORCEPS
  779. K832745OC3 FLYER
  780. K855232SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
  781. K760824TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I
  782. K780478LIQUID CRYSTAL THERMOGRAPHIC SYSTEM
  783. K100576HIGH PRESSURE SETS-400 PSI
  784. K060464COULTER 5C CELL CONTROL
  785. K781041ELECTROENCEPHALOGRAPH ACCUTRACE 100
  786. K902384ABDOMINAL OR C-SECTION DRAPE SHEET
  787. K841157HALOTHANE VAPORIZER 950, ENFLURANE
  788. K040939SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
  789. K953344DEGUBOND ULTRA
  790. K855000RATEMINDER III INFUSION DEVICE
  791. K010742MOSS MIAMI 5.5MM TITANIUM PIN NUT
  792. K974909SYNERMED CREATININE REAGENT KIT
  793. BK050026Tubes, Vials, Systems, Serum Separators, Blood Collection
  794. K041330IPLAN! FLOW
  795. K183004WEGO-PGA RAPID
  796. K840496ISOSTAT MICROBIAL TUBE PROCESSING
  797. K823132SARTOPHOR SYSTEM FOR ELECTROPHORESIS
  798. K900621FIAGEN(TM) HLH.S
  799. BK030088Assay, Genotype, HIV Drug Resistance, In Vitro
  800. K052387ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
  801. K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
  802. K062903SBI CARPAL FUSION PLATE
  803. K811132EUGON BROTH
  804. K910634DC200 DEFIBRILLATOR
  805. K234004Medical diode laser systems (CHARISMA, REGAL)
  806. K822866MOXALACTAM
  807. K812522RABBIT COMPLEMENT
  808. K820759VEIN-SHIELD
  809. K984039CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50…
  810. K770578PARALLEL PLATE DIALYZER
  811. K812509CT/T 8800
  812. K151199SmartDrive Wheelchair Power Assist
  813. K790451X-RAY UNITS, GX-101, UCIS-510 AND GX-111
  814. K882799HELENA COLOCARE
  815. K896532DENTAL DELIVERY SYSTEM
  816. K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
  817. K915130MAT MEMBRANE AUTOTRANSFUSION SYSTEM
  818. K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…
  819. K183264Flex-THOR scope
  820. K842247MELOY AUTOANTIBODY TEST SYS
  821. K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum…
  822. K932137FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
  823. K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
  824. K023378ORIA CLARIS
  825. K033713URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
  826. K023390MY BREAST FRIEND, BREAST SELF-EXAM PAD
  827. K062161GORE PROPATEN VASCULAR GRAFT
  828. K073348LUCENT MAGNUM
  829. K934649GALILEO ENDOSCOPES
  830. K974635PARAGON LENS CARE
  831. K841905DOT-A, DOT-AR PXP-E, PXP-ER
  832. K050307AIRIS ELITE RAPID BODY COIL
  833. K171539Contact Lens Case
  834. K963143ELECSYS CALCHECK TROPONIN T
  835. K955030SQUARE ONE SAFETY SYRINGE
  836. K800114SIEMENS-ELEMA AB MANUAL VENTILATION
  837. K840373FLEXIBLE ILLUMINATOR 10
  838. K042895SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
  839. K202266Reliance Cervical IBF System
  840. K980725EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
  841. K963260DRESSING CHANGE TRAYS
  842. K895685SMALL JOINT HAND INSTRUMENTS
  843. K7719648MM TROCAR & CANNUAL W/STOPCOCK
  844. K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
  845. K983294ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M…
  846. K020863CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
  847. K963170OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
  848. K874506USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)
  849. K912655MINIMAX OXYGENATION SYSTEM
  850. K030203LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
  851. K933090EZ-SPACER
  852. K882012LIFESTYLE SOF. CARE GEL CHAIR CUSHION
  853. K953266RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION
  854. K922090FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION
  855. K171842Geistlich Wound Matrix
  856. K944645SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL…
  857. K760777COLON-X
  858. K843727LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
  859. K954283ENERGIZED CONTAINER SYSTEM (MODIFICATION)
  860. K081904PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
  861. K863922VERSAFLEX(TM) DELTA ST(TM) MONITOR
  862. K182232Octane Mechanical Thrombectomy System
  863. K021577MODIFICATION TO EN-BLOC BIOPSY SYSTEM
  864. K141410ORAGENE DX OGD-500.001
  865. K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
  866. K944075CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
  867. K251100IPGTFL-02
  868. K934869STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA
  869. K930150SAFE-T-TUBE RADIOPAQUE
  870. K201710A View LCS
  871. K110692STREAMLINE TL SPINAL SYSTEM
  872. K881240CHLORIDE REAGENT SET
  873. K863672MODEL (MB-700) BLOOD PRESSURE MONITOR
  874. K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…
  875. K031797METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000…
  876. K091534LIGHTLAS MODEL 532
  877. K831072JURGAN PIN BALL
  878. K832408STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
  879. K032490TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
  880. K882286EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
  881. K033203WILSON-COOK TRI-TOME SELECT PLUS
  882. K821192YSI #24 & 24M GLUCOSE ANALYZERS
  883. K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
  884. K253099LIFEPAK 15 AC Power Adapter (41577-000333)
  885. K896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
  886. K092207RESTORELLE POLYPROPYLENE MESH
  887. K840740CIRCUIT BREATHING
  888. K913273DROLITE(TM) LIGHT SOURCE
  889. K992535ENDIUS SUCTION/IRRIGATION INSTRUMENT
  890. K970669AEROQUIP SAFESTART IV CATHETER
  891. K143460Cannulated Screw System
  892. K863825CO-OXIMETER SOLUTIONS
  893. K160907DePuy Actis DuoFix Hip Prosthesis
  894. K023188PRESS-FIT HEAD RESURFACING DEVICE
  895. K950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
  896. K100386DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
  897. K852045SED-FIX CONCENTRATE
  898. K883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
  899. K961605KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
  900. K884931ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE)
  901. K900132ACUFEX STERILE CANNULATED INTERFERENCE SCREW;
  902. K881402629V SPIROMETER, PULMONARY FUNCTION ANALYZER
  903. K792278DAHLBERG MODEL AE HIGH FREQUENCY / AID
  904. K874982PRISMA DISPOSABLE SIMCOE EXTRACTOR
  905. K143499eCligner
  906. K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
  907. K951744LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
  908. K252271Hemoclip
  909. K821822MODEL 1020 NA/K ANALYZER
  910. K053635MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
  911. K060738TDM N-ACETYLPROCAINAMIDE
  912. K853671BEAMSCAN
  913. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…
  914. K002915FLEXIBLE OCCLUSION SYSTEM
  915. K061970ELECSYS IGE II IMMUNOASSAY
  916. K102151POWDERED VINYL PATIENT EXAMINATION GLOVES
  917. K950357SURVIVAL KIT
  918. K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
  919. K812120GINGI-PLAIN CORDS & BRAIDS
  920. K993014MODIFICATION TO DOCUMENT THYROID CAL.VER
  921. BK820013Device, Blood Mixing and Weighing
  922. K880706SURGICAL BURS
  923. K843627VENESECTION TRAY, ADULT 6050
  924. K111538SKAFFOLD CIS
  925. K191250Southern Implants PEEK Abutments
  926. K890013KOTEX SUPER MAXI PADS
  927. K063732MICROPLASTY TIBIAL TRAYS
  928. K962380OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
  929. K161705U2 Total Knee System E-XPE products
  930. K923730MODEL 561 C-ARM PROCEDURES STRETCHER
  931. K042114MDL SERIES DIODE LASERS, MODEL MDL-10/15
  932. K861048PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
  933. K850439DESERET EPIDURAL CATHETER
  934. K853472FINGER TOURNIQUETTE
  935. K141727DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)
  936. K760174ADAPTER, RESECTOSCOPE
  937. K071265SMARTCHECK INR SYSTEM
  938. K120833DISCOVERY CT750 HD
  939. K944634ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
  940. K853242I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI
  941. K132854EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
  942. K827065SIEMENS SIRESKOP 4
  943. K121132EZSENSOR P DIGITAL INTRAORAL SENSOR
  944. K905731FLEXIBLE ENDOSCOPIC ELECTRODE
  945. K843808DUAL CHENNEL BRAIN ACTIVITY MONITOR
  946. K894098SYNTHES EXTERNAL FIXATION BONE CLIP
  947. K913383OXYGEN MASKS 81420, 81421, 81471 & 81461
  948. K191399BIOLOX CONTOURA Ceramic Femoral Head
  949. K000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
  950. K760343TRAY, CURITY CONTINUOUS EPIDURAL
  951. K891515C-52 GOLD BASE DENTAL ALLOY
  952. K870424LSP AUTOMATIC VENTILATOR, MODEL 456
  953. K982885PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
  954. K002120LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
  955. K801395VASCULAR CLAMP
  956. K881692DIDECO-SHILEY FLUID COLLECTION BAG
  957. K915583CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR.
  958. K837229TRANSDUCER MODELS 450, 451, 452, 453, 454
  959. K153039MRI Dynamic Analysis Plus
  960. BK890032Set, Transfer (Blood/Plasma)
  961. K261448neXus Ultrasonic Surgical Aspirator System
  962. K843265ID ZINE LD ISOENZYME CONTROL ABNORM
  963. K954164HYSTEROSCOPE
  964. K780616HYDRON BURN DISPOSABLE DISPENSER SET
  965. K223051Pre-Formed Silicone Block
  966. K142940Endoskeleton TCS System
  967. K941439RENALIN COLD STERILANT
  968. K842245ASPARTATE AMINOTRANSFERASE ASSAY KIT
  969. K880756MODEL PM-20A PHYSIOLOGICAL MONITOR
  970. K933036GOLD ASP MODULE, ITE
  971. K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…
  972. K120863WHOLEY GUIDE WIRE SYSTEM
  973. K060771POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
  974. K101415THERACLEAR
  975. K051476UNI-VENT MODEL 73X
  976. K020249MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
  977. K251805syngo.CT Dual Energy
  978. K110752HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
  979. K143316Attain Hybrid Guide Wire
  980. K223060DigiX FDX
  981. K922339SUTURE REMOVAL KIT
  982. K761301V-TRACE ECG BACKPAD
  983. K862061OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
  984. K882136INTERSEPT* OXYGEN GAS LINE FILTER
  985. K242300MI View&GO
  986. K935502EVENT TEST STRIP HCG
  987. K033100TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
  988. K924515ELECTRIC MOBILITY RASCAL
  989. K210218SURGICAL MASK, Model Name:C015
  990. K111202SURGICAL TISSUE MANAGEMENT SYSTEM
  991. K143424UTAH CVX-RIPE
  992. K860383BIOTIS CLOSTRIDIUM DIFFICILE AGAR
  993. K112958HUMID-VENT HEPA
  994. K192624ApneaTrak
  995. K894307LAWANA PATIENT EXAMINATION GLOVES
  996. K801791FERTILITY AWARENESS METHOD KIT
  997. K811320CAL-3 CALIBRATED RADIOACTIVITY ASSAYER
  998. K213961TruAbutment DS, TruBase
  999. K882566VISIO-PERL
  1000. K040266CORE NEEDLE BIOPSY

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