Orca1

Data catalog

510(k) premarket notifications

About 178K records

All records

Every 510(k) record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. K111030E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
  2. K002206HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS…
  3. K881361SOLID PHASE EXTRACTION TUBES
  4. K781594DENTAL WARM WATER IRRIGATING SYSTEM
  5. K874919ORTHOMET WIRE FOR SUTURE, CERCLAGE
  6. K911940OPUS(R) TOBRAMYCIN
  7. K052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
  8. K220302Disposable surgical face mask
  9. K922916BARD MARLEX MESH DART
  10. K953451UROPUMP TUBE & DAMPING CHAMGER
  11. K792225P1806 MOBILE C-ARM IMAGE INTENSIFIER
  12. K031178SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
  13. K861051ISOLIFE DISPENSING SYSTEM
  14. K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400…
  15. K792678CARDIAC OUTPUT COMPUTER, M-MLC-4100
  16. K954533ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES
  17. K002967M2376A DEVICELINK SYSTEM, MODEL M2376A
  18. K900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
  19. K861905PLOTTER MODEL (MP100)
  20. K932441SERIES 8920 TROCAR SYSTEM
  21. K945449UNICATH LLU ANGIOGRAPHIC SYSTEM
  22. K893888HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
  23. K904917THAYER MIP ADAPTER
  24. K970534PICTURE ARCHIVING & COMMUNICATIONS DEVICE
  25. K200439Velano ExT Extension Set
  26. K905108CONTORNO(R), MODELS E AND ST
  27. K851511ACCURATECARE I & ACCURATECARE II
  28. K050950MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
  29. K801551ARGYLE SAF-T-MARK SUCTION CATHETER
  30. K891857PATIENT EXAMINATION GLOVES (LATEX)
  31. K871346DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
  32. K080789BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
  33. K950865ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS…
  34. K945062VACPLUS
  35. K252239InVision™ 3T Recharge Operating Suite
  36. K885175MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
  37. K110878RHYTHMVIEW (TM)
  38. K203235VBrain
  39. K955073KSEA THERMOFLATOR (MODEL 26 4320 20)
  40. K081855IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
  41. K994383DOGBONE ACFS
  42. K240892XSense Cryoablation System with Cryoprobes
  43. K800055H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
  44. K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
  45. K082427SYNGO MR B17
  46. K941106MODEL TI500 ISOLETTE INFANT INCUBATOR
  47. K801855CYCLOPAC TENS
  48. K111194APNEA RISK EVALUATION SYSTEM (ARES)
  49. K992564AF-180 HEMODIALYZER
  50. K032108SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
  51. K242462CEREC Cercon 4D CAD/CAM Blocks
  52. K001775ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
  53. K915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
  54. K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
  55. K881222JOHNSON & JOHNSON FLUFF SPONGE
  56. K250520OsteoCentric Navigated Instruments System
  57. K864436STAVIP 3000
  58. K072685NGARDE SYSTEM
  59. K052446LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
  60. K043196ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
  61. K893745THE INDEPENDENT CARE UNIT
  62. K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
  63. K112718NUVASIVE NVM5 SYSTEM
  64. K003060PLASMAKINETIC GENERATOR
  65. K031409URINARY CATHETERS
  66. K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension…
  67. K810544INCONTINENT PAD & BELT
  68. K242952INNOVANCE Antithrombin
  69. K771988VERTETRAC
  70. K190489Elcam Stopcocks and Manifolds
  71. K851336IV/0165 INFUSION SET
  72. K823583MYOTEST NERVE STIMULATOR
  73. K240743Peak Universal Bond
  74. K193559NextAR TKA Platform
  75. K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
  76. K926158SLATER SLEEVE
  77. K014212BARD CONQUEST PTA BALLOON DILATATION CATHETER
  78. K890158RETRACTORS
  79. K033260AEQUOS
  80. K100372SAFECT MODEL VER 1.0
  81. K123021BIOPLEX 2200 EBV IGM KIT
  82. K031428SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
  83. K181640X-BOLT Hip Fracture Fixation System
  84. K934416OMNI 2000 SERIES ITE HEARING AID
  85. K800279MEDSPEC RUBBER BANDS
  86. K924406CONVEEN(R) LEG BAG(500 ML)
  87. K182359HipCheck
  88. K090279SEDECAL, MILLENNIUM PLUS
  89. K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
  90. K861994MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM
  91. K250190Sequential Compression System (SCD600)
  92. K043568EQUESTRA FLUID DELIVERY SYSTEM
  93. K210945Ultra SEP
  94. K830535FLOW-PAC ALKALINE PHOSPHATE REAGENT SET
  95. K040979ELEKTA MICRODRIVE, MODEL 916716
  96. K970176HCG CONTROLS
  97. K031108SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
  98. K160403SmartStart Air/Water and Suction Valves
  99. K020307LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
  100. K091518CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
  101. K970791INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
  102. K16202916ch T/R Knee Coil
  103. K940901NON-WOVEN SPONGE
  104. K231664IRRAflow Active Fluid Exchange System (AFES)
  105. K113852BAUSCH & LOMB IOL INJECTOR
  106. K171120Senhance Surgical Robotic System
  107. K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip…
  108. K925890MIRROR, MOUTH
  109. K992710ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
  110. K946069HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
  111. K261977Braun Aura 9 (6042)
  112. K072403NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN…
  113. K880007TOXO IGM TEST
  114. K893943FD 200 DENTAL STOOL
  115. BK910001Media, Potentiating for In Vitro Diagnostic Use
  116. K924912PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
  117. K014209PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
  118. K873967SPECTACLE, MAGNIFYING
  119. K946166FIRST CHOICE(TM) TEST STRIP
  120. K102681ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
  121. K182968Hoffmann LRF System
  122. K963975VERSATEC 310 ELECTRODE
  123. K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
  124. K872717QM300 HAPTOGLOBIN ANTIBODY PACK
  125. K941922MEDSAT OXYGEN SATURATION SYSTEM
  126. K943487BIO74-PF CROWN & BRIDGE ALLOY
  127. K981035PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
  128. K112452ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
  129. K984123THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME…
  130. K952651LIFE SOUND SENSOR
  131. K911377FORCEPS, COAGULATION, BIPOLAR, MALIS
  132. K923337ON*SITE ALCOHOL
  133. K151597Family of Steam Sterilizers B 28 series
  134. K860261CANNULA BAND
  135. K813307UVA HEX UNIT
  136. K926575MAMMOTEST PRODUCT, MODIFICATION
  137. K241775XeliteMed VertehighFix High Viscosity Spinal Bone Cement
  138. K031821MODIFICATION TO COOK ZILVER BILIARY STENT
  139. K962189COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
  140. K863643EPICARDIA, PC/FD
  141. K121609ASTHMAPOLIS SYSTEM
  142. K772381RING HANDLE & RETRACTORS
  143. K222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
  144. K781444OUTRIGGER DISTRACTION UNIT
  145. K190773Elecsys TSH
  146. K012620SE-200
  147. K950851GENT-L-KARE TRACHEOSTOMY TRAYS
  148. K834387YD STRIP GPH U21
  149. K894804SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
  150. K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
  151. K871568PLEURA-GARD ATS
  152. K232484KeyLift™ Expandable Interlaminar Stabilization System
  153. K934494SURGITEL
  154. K871782ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
  155. K042022E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
  156. K020674BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
  157. K900825'POLYSTIM'
  158. K021247PNEUMOPERITONEUM INSUFFLATION NEEDLE
  159. K102245CARE ZY5BA OXYGEN CONCENTRATOR
  160. K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
  161. K110949BICERA (TM) RESORBABLE BONE SUBSTITUTE
  162. K113871PRO-DENSE BONE GRAFT SUBSTITUTE
  163. K791393HISTOPLASMA YEAST ANTI #CF10021X
  164. K000672HELIODENT VARIO
  165. K855076ANGIOMED URETER DIATION SETS
  166. K896120SCHILLER MODEL SP-100 SPIROVIT(TM)
  167. K854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
  168. K052785OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
  169. K920105SCALAMOBIL
  170. K954931NEO-MED DLS-1100
  171. K000995NARKOMAT, MODEL 2000
  172. K192291TidalPort-AP Implantable Apheresis Vascular Access Port
  173. K930787LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
  174. K141005Z-LINK CERVICAL
  175. K933670BIOPSY PUNCH, SURGICAL
  176. K903911GEN-PROBE PAL LUMINOMETER
  177. K170969Eclipse Treatment Planning System
  178. K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
  179. K052083NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
  180. K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink…
  181. K942080SENSATEC ENDOSCOPIC INSTRUMENTS
  182. K943221SURGIBOND
  183. K123916PSA SERIES
  184. K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical…
  185. K060933SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
  186. K864714INFRALUX HEAT LAMP
  187. K981592ACS:CENTAUR AFP
  188. K000410SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
  189. K061097COHERENCE DOSIMETRIST, MODEL 2.2
  190. K250541Self-Forming Magnet (Flexagon Plus OTOLoc)
  191. K910906CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
  192. K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
  193. K992071TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
  194. K060986HEAD BED
  195. K891118STERLING TENS
  196. K904878SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
  197. K092755STERRAAD 100NX EXPRESS CYCLE TEST PACK
  198. K161650Polysmith Sleep System, Model NTI7593
  199. K093895ALLY PLATFORM SYSTEM
  200. K850225FISCHER'S MEDIUM
  201. K190344DePuy Corail AMT Hip Prosthesis
  202. K093291VARIAN INTERSTITIAL TITANIUM NEEDLES
  203. K863624ULTRAWASH II
  204. K183470Precision Ideal Eyes Arthroscopes
  205. K233512Rapid (6.0)
  206. K891354ORTHODONTIC COTTON ROLL HOLDERS
  207. K882470STERILE DISPOSABLE SURGICAL GOWNS
  208. K023818FIBERFILL AGP
  209. K811196ALLMEC 90/15
  210. K211283Compressible Limb and Circulation Therapy System, Model POWER-Q2300
  211. BK110048Blood Establishment Computer Software and Accessories
  212. K951943CHROM Z CHROMOGENIC ASSAYS
  213. K032832IRRIGATION SETS
  214. K243520Bullsai Confirm
  215. K182549StatStrip Xpress 2 Glucose Hospital Meter System
  216. K121583CLEARFIL MAJESTY FLOW
  217. K880432VICOR PACER, MODEL 410A
  218. K964262EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
  219. K021975LASERSYSTEM BEAUTYSTAR 532
  220. K251305Ultra-Fast Vitri; Ultra-Fast Warm
  221. K943855BONE FIXATION NAIL
  222. K832201CHROM-PREP
  223. K811071VENOUS OXYGEN PROBE
  224. K183397ChoiceSpine Stealth Cervical Spacer System
  225. K041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
  226. K882580MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
  227. K895485BIRD (IPV) NONCONTINUOUS VENTILATORS
  228. K223352Tenderfoot
  229. K912480BBL(R) DMACA INDOLE REAGENT DROPPERS
  230. K241416Ion 3D
  231. K840975RICO RESPIRATION MONITOR
  232. K212734Diode laser therapy device
  233. K220978TSX Implants
  234. K102631KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
  235. K234123Easi-Vue® embolic microspheres System
  236. K902183S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED
  237. K890090DANEK IRRIGATING BURR (DIB) SET
  238. K832747ALBUMIN REAGENT SET
  239. K884528SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
  240. K930685TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
  241. K954361ARGENCO 68M
  242. K943150DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
  243. K903332SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
  244. K771981MINIMAP MODEL 810
  245. K854222DIESSE RF TEST KIT
  246. K022540CARDIO ID+(RZ153+)
  247. K893043PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
  248. K141762PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
  249. K961749TRANSAMERICA ELECTRODE
  250. K950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
  251. K172056InnoSight Diagnostic Ultrasound System
  252. K951210WELCH ALLYN VIDEO OPHTHALMOSCOPE
  253. K102345EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
  254. K964830ELECSYS CALCHECK LH
  255. K983780MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
  256. K770877DATA REDUCTION SYSTEM, DP-3000
  257. K781890CHAMBER, MC-1 DISPOSABLE PRESSURE
  258. K924178MEDVISION(TM) IMAGING SOFTWARE
  259. K260804Anovo Surgical System (6Ne)
  260. K904299SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
  261. K212391MCI-Neuro Fixation System
  262. K970722EYE TRAY
  263. K884750GROUP A STREP, BETA-STREP
  264. K002735ASCENT XXL OPEN BOX FEMORAL COMPONENT
  265. K001754MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
  266. K973407SUNGLASSES (NON-PRESCRIPTION)
  267. K926201OSTEONICS MICROSUTERED FEMORAL COMPONENTES
  268. K073229NERVE MONITORING CABLE
  269. K792505RIONET HEARING AID HB-32T
  270. K1728152MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
  271. K083320DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
  272. K842314DUOCLON COLOR-CEPT
  273. K023545ULTRA-LITE 200E LIGHT CURE UNIT
  274. K032088MODIFICATION TO THERMACOOL TC SYSTEM
  275. K844093JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
  276. K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
  277. K972574STELA MODEL UJ45 PACING LEADS
  278. K882258DC-LIQUICAL CATALOGUE #SE-030
  279. K904486SUPPORT PUMP
  280. K082856CARAPASTE ORAL WOUND DRESSING
  281. K240798Cntrl+ Bladder Support Pessary
  282. K915133SYNELISA TMAB
  283. K930200MULTI DOPPLEX II / FETAL DOPPLEX II
  284. K770431CATHETER, TWO STAGE VENOUS RETURN
  285. K831416EMIT QST TOBRAMYCIN ASSAY
  286. K871687TYTEM(R) REAGENT DISPENSER
  287. K994162POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75…
  288. K830111SEPTOCAL
  289. K943339GAUZE SPONGE (E.W.A. LTD./VARIOUS)
  290. K904901L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC
  291. K872483MODIFIED ALT (GPT) REAGENT
  292. BK850026Container, Empty, For the Collection '& Processing of Blood/Blood Components
  293. K933142ACCESS VITAMIN B12 ASSAY
  294. K840183DESERET MULTILUMEN SUBCLAVIAN JUGULAR
  295. K041774IUR RECIPROCATING MORCELLATOR MODEL # 7210517
  296. K872630ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
  297. K202171Pulmogine Vibrating Mesh Nebulizer
  298. K050703QBRAIN
  299. K161568Bone Solutions Mixing and Delivery System
  300. K173662speX Support Catheter
  301. K010908MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
  302. K896675STERLING STYLE 90 SURGICAL GLOVES
  303. K951314TRUEFILL PVA PARTICLES
  304. K062204ARCHITECT CORTISOL ASSAY
  305. K837142TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM
  306. K965041OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
  307. K840029STRIPS
  308. K200456Becker External Drainage and Monitoring System
  309. K861260PEDABAROGRAPH
  310. K790224PADIATRY PACK & SHEET WITH FABRIC 450
  311. K953750CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  312. K822988COAGULASE PLASMA-CITRATED & EDTA
  313. K802831GAMBRO PERITONEAL DIALYSIS MONITOR
  314. K182820The POD
  315. K043363FRESENIUS LIBERTY CYCLER
  316. K032916MIRAGE ACTIVA MASK
  317. K092807HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
  318. K131569PG-800A SERIES
  319. K141998SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
  320. K233366SYMPHONY OCT System
  321. K861140PROGRAMALITH III PULSE GENERATOR
  322. K972391VISTA ANTIGEN SALMONELLA H B
  323. K841266MONTGOMERY TRACHEAL T-TUBE
  324. K990585INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
  325. K941991IN-ROOM AND SHARPSTAR
  326. K950719OES UROLOGY
  327. K954555VERSA-FX FEMORAL FIXATION SYSTEM
  328. K860777MATRIX LD & LD/LASER DIGITIZER
  329. K894662TEST ONE
  330. K984257MEDRAD PHASED ARRAY NEUROVASCULAR COIL
  331. K931657NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
  332. K953536SLANT/FIN HEPA CLEAR
  333. K961972MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
  334. K890595MENTOR ANTERIOR SEGMENT VITRECTOR
  335. K102101SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
  336. K820037SICKLE-CHECK
  337. K893382ARGENCO 63 TYPE III DENTAL GOLD ALLOY
  338. BK910025Supplies, Blood-Bank
  339. K142596Infusomat Space Volumetric Infusion Pump
  340. K013805KOWA AUTOMATED TONOMETER KT-500
  341. K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
  342. K231986Modus IR
  343. K881833NASAL CPAP SYSTEM
  344. K181334ADVIA Centaur Herpes-2 IgG
  345. K073009ONEPORT SURGICAL TROCAR SYSTEM
  346. K253963Cubresa BrainPET
  347. K201666SINGLE USE MANOMETER
  348. K850938CHOLESTEROL
  349. K925162MICRODOSE DENTIN CONDITIONER
  350. K791660PREPACELL-BONE MARROW SAMPLER
  351. K950340IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS
  352. K852345SEA-LONG NECKSEAL & HOOD
  353. K952115BARRIER GOWN, KOOL-GARD BACKLESS GOWN
  354. K883876WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE
  355. K931644GERTIE MARX NEEDLE
  356. K982329VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
  357. K863261CREATININE PROCEDURE
  358. K013160POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
  359. K120569GEMORE TENS SYSTEM
  360. K102219SOCORRO SMI TUNNEL RELEASE DEVICE
  361. K860754KODAK T-MAT M FILM SO-245
  362. K933628CYTOLOGY BRUSH
  363. K940612E.M.A.
  364. K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER…
  365. K033521BISBLOCK
  366. K920752ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
  367. K894023PATIENT EXAMINATION GLOVES (VINYL)
  368. K993602PRE-VISION FILL
  369. K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
  370. K143173Stryker CMF MEDPOR Customized Implant
  371. K843734NEMDI
  372. K102957CUTTING EDGE SPINE INTERBODY FUSION DEVICE
  373. K852788RUBALEX
  374. K861152EXEL VACUUM BLOOD COLLECTING SYSTEM
  375. K760439PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY
  376. K983723CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
  377. K182970EUROPA™ Pedicle Screw System
  378. K926181ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
  379. K231979Mecun SpO2 sensor
  380. K851830SKYTRON ELITE 7000 MICRO-SURGERY TABLE
  381. K960979SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
  382. K253108VEOFIX Snap Off Screw
  383. K842365CORTI-COTE CORTISOL SOLID PHASE RADIO
  384. K862871RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
  385. K861535OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
  386. K160431ActiveCare Home
  387. K904326DE-TOX TUBES A AND DE-TOX TUBES B
  388. K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
  389. K243074Spectrum Spine Lumbar Cage System
  390. K010981GSA GENITO SENSORY ANALYZER
  391. K092704ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91…
  392. K870078ACCUPEN(R)
  393. K900850EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
  394. K181139OLYMPIC Posterior Spinal Fixation System
  395. K261609Freedom Partial Knee System
  396. K241357XT3 System
  397. K071292VIEW MD OFFICE SYSTEM, MODEL 41066.5540
  398. K230350VISULAS yag
  399. K024081DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
  400. K220739Disposable Urine Collection Tube
  401. K800839MEDESCAN
  402. K894425ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
  403. K943931CARRYALL ENHANCEMENTS
  404. K884670EXEL 1800 AND 1800E CT SCANNER
  405. K260086CadAI-B Dx
  406. K061517PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT…
  407. K220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
  408. K974561MOISTAIR FLUID AIR TUBING SET
  409. K940606HISPEED ADVANTAGE II
  410. K163025DORA Disposable A.V. Fistula Needle Sets
  411. K831523BETA SCAN NORMAL CONTROL SOLUTION
  412. K012667REPROCESSED ARTHROSCOPIC SHAPERS
  413. K183422Wireless Digital Flat Panel Detector
  414. K882604PULMO-PATTY
  415. K191340CORTRAK* 2 Equilateral Enteral Access System
  416. K905176POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
  417. K981653AMY
  418. K052010HBA1C LINEARITY SET
  419. K890119BR-S601MU (SURGICAL VIDEO RECORDER)
  420. K161155Origin Coxa Vara Hip Stem
  421. K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
  422. K931354P4000 PHACOEMULSIFIER
  423. K872926DERMATOLOGICAL PATCH
  424. K955947OSTAR EXAMINATION GLOVES
  425. K801676FERRIZYME FERRITIN ENZYME IMMUNOASSAY
  426. K993983SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
  427. K780673CENTRAL CATHETER KIT
  428. K860237OMF-7101 FETAL MONITOR
  429. K071709ARTHROCARE SYSTEM 12000
  430. K110225ANGIODYNAMICS, INC. VENACURE 1470 LASER
  431. K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
  432. K991775MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
  433. K902381PENLON BREATHING SYSTEM PRESSURE MONITOR
  434. K963410POSEY STRAIGHT JACKETS
  435. K760250BANDAGE, TRIANGULAR NO. 8068
  436. K203800SyntrFuge System
  437. K130242MAVEN PRO
  438. K822889MODEL #6200 OXYGEN CONCENTRATOR
  439. K895650ENTERAL PUMP SET W/ENTERA-FLO SPIKE
  440. K191760PICO 14 Single Use Negative Pressure Wound Therapy System
  441. K882096SCOPIX VIDEO IMAGER
  442. K813314NLD IMPLANT SET
  443. K231550Sontro® OTC Hearing Aids (AI)
  444. K991286AVOCET ACUSURE SYSTEM
  445. K812856CHEMICAL INDICATORS
  446. K883014MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
  447. K181523Syneron CO2RE System
  448. K093447CARRIGEN
  449. K011840CERVILENZ UTERINE MEASURING SOUND
  450. K830864WHITE BLOOD CELL CONTROL
  451. K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
  452. K950993BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
  453. K850669PROMINJECT PROGRAMMABLE INFUSION PUMP
  454. K181405Hailie Sensor
  455. K790437TRACH CARE KIT
  456. K832624TOP VENULA I.V. CATHETER SET
  457. K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6…
  458. K021494GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
  459. K230915AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
  460. K903339VIDEO ENDOSCOPE, RIGID
  461. BK210562System, Test, Automated Blood Grouping and Antibody
  462. K832546MARK V HIGH VOLTAGE GALVANIC STIMULATORR
  463. K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…
  464. K912921VSI 1000
  465. K080995MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
  466. K905355BROAD SELF-COMPRESSING PLATE
  467. K243496MycoMEIA Aspergillus Assay
  468. K924420MEDICAL DISPOSABLE BEDDING
  469. K914497BIOPSY FORCEPS
  470. K031610REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
  471. K090521DIAMONDBACK 360 DBX
  472. K851057LASERFLO BLOOD PERFUSION MONITOR 403
  473. K905215IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
  474. K990494MODIFICATION OF NOGA
  475. K182150Devon 52 Sequential Compression Device
  476. K262637SLIT LAMP SL-D4 (Type: LED)
  477. K913537MEMOSIL C.D.
  478. K972201PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
  479. K130124CATALYST II AND III
  480. K874075PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE
  481. K884176CHROMATOGRAPHY KIT
  482. K922443VERT-X UNIVERSAL VERTICAL BUCKY STAND
  483. K211475Vital Signs Monitors
  484. K822040POWERED EMERGENCY VENTILATOR
  485. K890513SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
  486. K771177SURGICAL STAPLING INSTRU., AUTO, SUTURE
  487. K190540Ponto 4
  488. K941538SUNGLASSES
  489. K864978APPLISCOPE
  490. K926079DMI LAPAROSCOPIC ELECTRODES
  491. K133527SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
  492. K851738MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &
  493. K013617LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
  494. K991560NASO-LARYNGO-PHARYNGOSCOPE
  495. K242680LetsGetChecked Impress
  496. K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
  497. K242768Customized Abutment and Screw
  498. K031000LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
  499. K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
  500. BK850012Test, Qualitative, for HLA, Non-Diagnostic
  501. K003822ISOLA CLOSED DUAL ROD CONNECTOR
  502. K093565PLEURAFLOW CATHETER SYSTEM
  503. K822447SURGICARE MODEL 1000
  504. K024361EM PROBE, EM PAD
  505. K133164DYNESYS TOP-LOADING SPINAL SYSTEM
  506. K042758POLYTECH PULMONARY FUNCTION FILTER
  507. K103284LAMINOPLASY PLATING SYSTEM
  508. K760071TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4
  509. K960090CALCOFLUOR WHITE STAIN KIT
  510. K080411PLATEAU SPACER SYSTEM
  511. K964761S.A.M. FACIAL IMPLANT W/INTRODUCER
  512. K935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
  513. K963331MEDTEXX
  514. K981929BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
  515. K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement…
  516. K082636TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
  517. K873524AFFINITY HCG IMMUNIT (POLYCLONAL)
  518. K212085Siam NTD+ Nitrile Powder-Free Examination gloves
  519. K884513PF TEST
  520. K882823FIAGEN HGH FLUOROIMMUNOASSAY KIT
  521. K163008CareLink SmartSync Device Manager - Pacing System Analyzer
  522. K023032LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
  523. K850338EMERGENCY ROOM PACK
  524. K162408Nano Varnish, Plaquit, Lightpaint on Surface
  525. K971221GREINER VACUETTE BLOOD COLLECTION TUBE
  526. K821855VISCO HANDEX-VARIOUS MODELS
  527. K854140MODIFIED MYDRIATIC SPECTACLE
  528. K972673AVL 9181 ELECTROLYTE ANALYZER
  529. K260697VyPlate™ Anterior Cervical Plate System
  530. K760620SALIVA EJECTOR
  531. K153620Enovare Ultrasound System
  532. K992500CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
  533. K962301STERNGOLD G-HARD METAL ALLOY
  534. K901129BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
  535. K253794Prostate Core
  536. K002579DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING…
  537. K051195GRAFTON DBM
  538. K211842Servator M SALF Solution
  539. K871451BESTCON/SPERMICIDE
  540. K112933ACCESS THYROGLOBULIN ANITBODY
  541. K010241PROTRACT PRESS FIT HIP STEM-HA COATED
  542. K831758FLOW-CALIBRATION MODULE
  543. K150892CorPath 200 System
  544. K190972Ambu aScope 4 RhinoLaryngo Intervention
  545. K202621NeuroSENSE Monitoring System, Model NS-901
  546. K171423Nasal Alar SpO2 Sensor
  547. K882578ASTRA DENTAL IMPLANT SYSTEM
  548. K833337VOLUREX II
  549. K852677MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
  550. K940763ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
  551. K123948CHINA NAILS AND ACCESSORIES
  552. K020317NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE…
  553. K931138CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP
  554. K771522FORCEPS, STYLE #849
  555. K181872MIS Bunion System
  556. K980694KSEA PLASTIC TROCARS
  557. K780173LYPOPROTEIN CHOLESTEROL TEST KIT
  558. K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
  559. K221504BD Surgiphor™ Antimicrobial Irrigation System
  560. K0932841.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
  561. K831307PECOR 8.5 FRENCH IAB ON A DATASCOPE
  562. K131120AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
  563. K070569SM INTERNAL./EXTERNAL IMPLANT SYSTEM
  564. K905564PREP AND OPERATING STAND
  565. K143444SynePure Wound Cleanser
  566. K863651POLAREX AND POLAREX MLD
  567. K973632DUODERM CGF CONTROL GEL FORMULA DRESSING
  568. K943767IMMULITE C-PEPTIDE
  569. K841383CSPI ROTARY SURGICAL ASPIRATOR
  570. K951277R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410
  571. K965083SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET…
  572. K850791MDI 2000 - PULSE GENERATOR
  573. K220010Daylily Single Use Sterile Embryo Transfer Catheter
  574. K913056VOLUMETRIC INFUSION PUMP, MODIFICATION
  575. K780995COMPUTERIZED AXIAL TOMOGRAPHY
  576. K965067DILATION CATHETER, BALLOON
  577. K260919Transurethral Catheter Safety Valve (TUCSV) (80050)
  578. K905106AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
  579. K863864AMBULATORY INFUSION PUMP, MODEL AS30C
  580. K770211MICROPULSE MODEL 20S
  581. K170934C3 Wave System
  582. K033352VERTEBRON PSS PEDICLE SCREW SYSTEM
  583. K183536Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per…
  584. K132646SUNETICS CLINICAL BIO-STIMULATION LASER
  585. K821235HEPARIN COATED THERMODILUTION CATHETER
  586. K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
  587. K892835E350 ELECTROCARDIOGRAPH
  588. K972891ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT…
  589. K892942BREATH TRACKER
  590. K020291EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
  591. K841337ULTRACLONE ECL-01-800 CELL LINE
  592. K851226I.V. START KIT
  593. K060331SIGMA ALPHA VAPORIZER
  594. K880877CONTRAST INJECTION DEVICE
  595. K973401TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
  596. K972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
  597. K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX…
  598. K262196Invisalign System
  599. K781798TINNITUS MASKER
  600. K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER…
  601. K981686STEALTHSTATION SYSTEM DIGITIZER CHANGE
  602. K161916TelePatch Cardiac Monitor
  603. K150593Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
  604. BK880022Supplies, Blood-Bank
  605. K943456AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
  606. K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
  607. K924622CYTOQUANT A-549 CELLS, CATALOG #02-201
  608. K970014TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
  609. K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
  610. K844058CODE-A-WALL SERIES 1-250 INOCULUM TRAY
  611. K200155Bright High Flow
  612. K955212SAS SALMONELLA H FACTOR 5 ANTISERUM
  613. K170741GTK Disposable Needle Guides
  614. K223099Facet Manatee Reusable Lancing Base
  615. K031540APEX ELECTRIC HANDPIECE SYSTEM
  616. K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
  617. K063121PORTABLE X-RAY SYSTEM, MODEL PORT-X II
  618. K771608A-GENT TRIGLYCERIDES
  619. K210767Surgical Masks, Model:FE-1
  620. K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
  621. K023535TRIPTER X-1 COMPACT DUET
  622. K072371ODYSSEY WORKSTATION
  623. K091252IMPLANT CENTER 2
  624. K843152SYSTEMATE CALCIUM 67214
  625. K033630MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
  626. K992028REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
  627. K813500OMS INFUSION-ASPIRATION HANDLE
  628. K915761BIVONA-COLORADO VOICE PROSTHESIS
  629. K934067POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
  630. K951055OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
  631. K902691DOPPLER OPTION FOR PLATINUM
  632. K943504RSX-525HF
  633. K791088MONOJECT PULP-CAPPING MATERIAL
  634. K002805KENDRO HERACELL CO2 INCUBATOR
  635. BK080069Blood Establishment Computer Software and Accessories
  636. K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
  637. K861546REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
  638. K102777TWISTCUT ENDOSORB SCREWS
  639. K820902MULTIPERFECTEMP
  640. K802491REIGNING REPAIR EPOXY RESIN
  641. K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
  642. K201849eNAT molecular collection and preservation medium
  643. K190059CEREC Guides
  644. K931868PRIMADRY PRODUCT LINE
  645. K771393ELHCTRONIC SPHYGMOMANOMETER
  646. K010098MODIFICATION TO CAVERMAP SURGICAL AID
  647. K162608ClariFix Device
  648. K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)
  649. K143397ICIS View
  650. K243714da Vinci SP Surgical System (SP1098)
  651. K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
  652. K010326WAKO AUTOKIT C3
  653. K141837DRX-EVOLUTION
  654. K033016PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS…
  655. K830884SURGITEKS PERCUTANEOUS ANTEGRADE ALL -
  656. K821590PORS-ON
  657. K062112SUNMED FOLEY CATHETERS
  658. K932621RH-801/GS MODEL TRANSQ(R)1
  659. K844714SELECTRON LDR SELECTRON LOW DOSE RATE
  660. K931725ALPHA II
  661. K082175MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
  662. K834189JAKOBI SURG. INSTRUMENTS #7 44/47
  663. K771962CAMERA ADAPTER FOR ENDOSCOPES
  664. K993679MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
  665. K180641Invenia ABUS Viewer
  666. K972277DIGIFLEX SURGICAL GLOVES
  667. K771580TEKTALLY II
  668. K232680fMRI Hardware System
  669. K060566MINXRAY, MODELS HFP24 AND HFP40
  670. K820622ELECTROSTIMULI AVERSION MACHINE
  671. K061045REPROCESSED ELECTROPHYSIOLOGY CATHETERS
  672. K982905MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
  673. K140091XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
  674. K013696SILMED NASAL SEPTAL BUTTON
  675. K970425EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
  676. K970914CHASE AORTIC PERFUSION CANNULA
  677. K871787ENURESIS ALARM
  678. K902848FASTRECON 88 PERIFERAL
  679. K844972ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
  680. K203179Fortress Introducer Sheath System
  681. K002404MICRO-MAX, MODEL 319
  682. K110129RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
  683. K935155MERSHON BAND PUSHER
  684. K013163UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
  685. K865049GDC 1824
  686. K122141IDS-ISYS IGF-I CALIBRATION VERIFIERS
  687. K192397TruDi Navigation System
  688. K945973FMS ARTHROSCOPY CANNULA
  689. K925563FT MODEL TABLE W/ELECTRIC HI LO OPTION E
  690. K201877OtoSet- Ear Cleaning System
  691. K140296CLEARLUMEN THROMBECTOMY SYSTEM
  692. K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…
  693. K925346EP AMP, MODEL #901
  694. K111457CD HORIZON SPINAL SYSTEM
  695. K921834AUTOMATES COMA COCAINE METABOLITE ASSAY
  696. K833310FOGCUTTER DENTAL MOUTH MIRROR
  697. K911260ATRAUMATIC STANDARD SPROTTE NEEDLE
  698. K861305INTRAUTERINE CATHETER
  699. K780341SCINTILLATION, LIQUID, RACKBETA
  700. K123665LIFELINES IEEG
  701. K963440DIALOG DIALYSIS MACHINE
  702. K872249SIRECUST MODEL 960 AND 961 PATIENT MONITORING
  703. K091145FLEXIPLAN 3D AND 3D+
  704. K182478Whistler Modular Pedicle Screw System
  705. K041790DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
  706. K813005KODAK CINEFLUOROGRAPHIC FILM SO-274
  707. K912354OLYMOUS XLS XENON LIGHT SOURCE
  708. K821721CLINICAL DATA APNEA DETECTOR
  709. K211969EMM Ultrasonic Transducer Cover
  710. K914430NATRACARE TAMPON
  711. K890447HEMORRHAGE OCCLUDOR
  712. K791670SABOURAUD AGAR MODIFIED
  713. K201441Elecsys Troponin T Gen 5
  714. K123766NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
  715. K121367ZOLL PROPAQ XM
  716. K820101SHARPLAN 720 CO2 SURGICAL LASER
  717. K934209SLT REFLECTING PROBE
  718. K233807LumiVy™ Lumbar IBF System
  719. K863139TERUMO RADIFOCUS INTRODUCER KIT
  720. K791224MALIBU LABS MODEL 800 FINGER TIP CONT
  721. K913451HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
  722. K780745RUBBER DAM
  723. K243918Vasoview Hemopro 3 Power Supply
  724. K1333314D INTEGRATED TREATMENT CONSOLE
  725. K844570QUANTUM 412
  726. K123662THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
  727. K060134APOLLO IR HEAT LAMP SYSTEM
  728. K884349ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
  729. K843332ALKALINE PHOSPHATASE REAGENT SET
  730. K832430FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
  731. K864558U66 EMS
  732. K864210MICROSELECTRON-HDR (HIGH DOSE RATE)
  733. K983724ORCA-DX BONE DENSITOMETER
  734. K011208BIOVER
  735. K940394AMG MED BRAND CLINICAL GLASS THERMOMETER
  736. K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G…
  737. K970128ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
  738. K760939CORTISOL REAGENT SYSTEM
  739. K113255PUREGRAFT 850/PURE SYSTEM
  740. K014011CANVAS N-VAS-D 2.0
  741. K163373PK AIM
  742. K915503FIBRINOGEN FDP CONTROL
  743. K093229CATHETER CONNECTIONS DUALCAP
  744. K994437CYNOSURE PHOTOGENICA SPIR
  745. K970423INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
  746. K063288SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
  747. K172424Velofix™ SA Cervical Cage
  748. K023005AQUILLA MODULAR WHEELCHAIR
  749. K790959LIFEPATCH ECG ELECTRODES
  750. K964029EMERGENCY RELIEF KIT SYSTEM
  751. K031168MATRIX STRETCH RESISTANT DETACHABLE COIL
  752. K251926enCore Impression Material
  753. K944713W&H MICRO AIR MOTOR LT25
  754. K934039INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
  755. K183426MectaLIF Anterior Stand Alone Extension
  756. K834352ADULT VENT CATHETER
  757. K183065Coolrail Linear Pen
  758. K123019LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
  759. K022067CONVOY ADVANCED DELIVERY SHEATH
  760. K240108Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01…
  761. K837347LINEAR ACCELERATOR THERAC 25
  762. K850315UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050
  763. K860979DONALDSON NATURAL EYEPATCH
  764. K052611ECP HEALTH SYSTEM, MODEL 2005
  765. K930982ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
  766. K191402Heater-Cooler System 3T
  767. K230668Disposable High-pressure Extension Lines
  768. K760798FLUOCAL GEL MINT
  769. K853663ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
  770. K000336RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
  771. K240355FROG (Filter Removal of Glass)
  772. K770333FLUOROSCOPE, C-ARM
  773. K972272LASER PERIPHERALS HOLMIUM BARE FIBERS
  774. K973171NIR BILIARY STENT
  775. K103251DUOCENTRIC REVERSED
  776. K011167XSE
  777. K062860MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
  778. K173130Reform® Midline Cortical Screw System
  779. K072273BELMONT QUOLIS 5000 SERIES DENTAL UNIT
  780. K010810DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
  781. K911266MODIFIED PK TP CONTROL
  782. K1209812.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
  783. K871651COLORIMETRIC BUN REAGENT KIT
  784. K760105BAG, URINE COLLECTION, CLOSED SYSTEM
  785. K830058MYOGRAPH 2000
  786. K100224ESTECH COBRA BIPOLSR II
  787. K871841THREE FLUID I.V. SETS
  788. K983783HEATED HUMIDIFIER
  789. K870223AMEDA AMELETTE(R) NEONATAL INCUBATOR
  790. K212608RibFix Blu Thoracic Fixation System
  791. K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…
  792. K033254FORTE GAMMA CAMERA SYSTEM
  793. K861417ASSERA-PLATE VWF KIT
  794. K890610VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
  795. K073466SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
  796. K140505ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND…
  797. K004028ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
  798. K252461Swedge™ Pedicle Screw Fixation System Bezier Rod
  799. K022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
  800. K050887GONGDONG DISPOSABLE VAGINAL SPECULUM
  801. K041633GYRUS PLASMACISION LAPAROSCOPIC SPATULA
  802. K142772Phlebo Press DVT 603
  803. K243680Neurovascular Insight V1.0
  804. K254183MR Conditional Cup Electrodes
  805. K181461Rapid-i™ Kit
  806. K011684INFLUENZA A/B RAPID TEST, CAT NO 2158 663
  807. K871192SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
  808. K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
  809. K832969WALKING CANE
  810. K922231OLYMPUS CHOLESTEROL REAGENT
  811. K945995BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS
  812. K201082LTV2 Series Ventilators
  813. K002058VECTORSURGE 5, MODEL VS-500
  814. K923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
  815. K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
  816. K080114HUAYI H035 BASIC WHEELCHAIR
  817. K003046IMAGE VASCULAR LASER
  818. K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
  819. K112273ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
  820. K902138STRIPE PROJECTOR
  821. K942686NORELCO CLEAN AIR SYSTEM MODEL CAM665
  822. K911835RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM
  823. K853804VICON (MODIFICATION)
  824. K952944MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
  825. K193143Stryker Facial iD Plating System
  826. K092235BEYONDIMAGE WORKSTATION
  827. K091296POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
  828. K082169PRO GLUCOSE TEST STRIP
  829. K936145COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
  830. K070055BONALIVE GRANULES AND BONALIVE PLATES
  831. K912128MAXI-SCOPE OR ULTRA-SCOPE
  832. K760195REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
  833. K973198VGF-7 VASCULAR GRAFT FLOWMETER
  834. K843260ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE
  835. K072785TWINFIX FT PK
  836. K241489ReminGel
  837. K163387PICO Single Use Negative Pressure Wound Therapy System
  838. K852609MEVASSIST(SETUP CONTROLLER)
  839. K213897Pro M Class
  840. K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
  841. K063414MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
  842. K850116BETASONIC III
  843. K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
  844. K042526DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE…
  845. K946257LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
  846. K771838SERUM IRON
  847. K060284CRYOCHECK CLOT APCR
  848. K2538993D-Anywhere
  849. K864548ALFERR TIBC TUBE
  850. K870842SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
  851. K874172BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)
  852. K801132BOUNDARY EXTREMITY DRAPE
  853. K900382BLUBLOCKER SUNGLASSES
  854. K0933591103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR…
  855. K926315PRACTICE PARTNER
  856. K820979RESILIENT GUM EXERCISER
  857. K090154SPI DENTAL IMPLANT INICELL
  858. K100703STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
  859. K090641CURIOS
  860. K013770MODIFICATION TO: WINNER ST-2 STIMULATOR
  861. K150137SpiroThor
  862. K053303CARDIOCOM COMMANDER III
  863. K000594LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
  864. K050980ULTRASONIC BIO-MICROSCOPE, MODEL P60
  865. K780072GLUCOSE REAGENT SET
  866. K820625HEMALET AUTOMATIC LANCET DEVICE
  867. K024259PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
  868. K820142TUBULAR STOCKINETTE
  869. K875277ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
  870. K172535Bipolar applicator CELON ProCurve V
  871. K211485STA- NeoPTimal
  872. K153571Cavilon Advanced High Endurance Skin Protectant
  873. K013169IMMUNE CELL FUNCTION ASSAY
  874. K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
  875. K990850COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
  876. K973747CONTROLLED TEMPERATURE CABINET SYSTEM
  877. K123995MICRODOSE SI
  878. K083336LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1…
  879. K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND…
  880. K202159actiTENS
  881. K832758RED COLOR-TINTED TUBING
  882. K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…
  883. K920355SPECIALTY SPONGES
  884. K093567ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
  885. K120077COMED K-SERIES MANUAL WHEELCHAIR
  886. K083438BIFIX SE
  887. K212570OsteoPlan System
  888. K894841IRIS OCULIGHT(TM) SL
  889. K842801ULTRAMED 11S601
  890. K133719PDE-NEO
  891. K000940HUMAN SERUM ALBUMIN (HSA)
  892. K210582EasyClip® and EasyClip® Xpress
  893. K182712DEXIS CariVu 3-in-1 by KaVo
  894. K810710HOLLISTER SKIN BARRIER B
  895. K971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
  896. K001382AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
  897. K010465DENSTAT
  898. K961212SPINAL TOUCH
  899. K911890OSTEONICS(R) PRT HIP STEM SERIES
  900. K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
  901. K172956Medicant Mucosal Atomizer
  902. K881372ENDICOTT & BEAMAN SUPRA-TEC FACE MASK
  903. K212832TimeWaver Frequency
  904. K901715KLEIN CORK(TM)
  905. K132523MYOPERFUSION
  906. K871466VESTIBULAR AUTOROTATION TEST
  907. K822594POLYETHYLENE CARDIOVASCULAR CATHETER
  908. BK950053Blood Establishment Computer Software and Accessories
  909. K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
  910. K210858VITROS Chemistry Products PHBR Slides
  911. K222245ACR Screw System
  912. K160504RI Witness Embryology Heated Plate
  913. K781862BLOOD GROUP SUBSTANCE A
  914. K010550VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
  915. K7921968 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
  916. K011222PORTABELL, MODEL 4200
  917. K830497PEM-T
  918. K042867PHILIPS ORTHOPAEDIC APPLICATIONS
  919. K942923CERES 900C & CERES UV900C
  920. K110701ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
  921. K061056RANDOX LIQUID PROTEIN CALIBRATOR
  922. K090717FLEX-TENS
  923. K813132THE CHICAGO GULLET
  924. K832144SPLINT WOOD
  925. K903373CATHETERIZATION C-ARM SUPPORT MH-51C(F)
  926. K911961BRANEMARK SYSTEM-5.0MM FIXTURE
  927. K881185ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
  928. K862631BARD IRYFIX(TM) STOMA CAP
  929. K854158RESNICK EMITTER, ARTIFICIAL LARYNX
  930. K882598250 ML BAG W/Y INJECT. & 12 EXTENSION SET
  931. K902989G.E. MONITROL 90 AND G.E. MONITROL 15
  932. K903366KETONE TEST B SANWA STANDARD
  933. K912030CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
  934. K013850STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
  935. K112209PREFILLED CATHETER INFLATION SYRINGE
  936. K810538PLASTICEPH
  937. K202651NOA Sleep Apnea and Snoring Device
  938. K993731SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
  939. K093455CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
  940. K033216BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
  941. K961543SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
  942. K841817TECHNICARE 248 SL & 260SL
  943. K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
  944. K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)
  945. K862863MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
  946. K123024TORQUE DEVICE
  947. K211778Nitrile Examination Gloves, Green/ Blue/ Black Color
  948. K823598LARGE TERRYCLOTH BIB
  949. K940210VISITEC EYE PAD
  950. K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
  951. K96355424448-010 SECURE-ALL FINGER CONTROL MITT
  952. K192189Avenir Complete Hip System, Size 0 Coxa Vara
  953. K002780VIATRONIX VISUALIZATION SYSTEM (VVS)
  954. K213824Sonopet iQ Ultrasonic Aspirator System
  955. K040238SOFTSEAL HSG CATHETER
  956. K925855DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
  957. K951462AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
  958. K944202ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
  959. K892169PATIENT EXAMINATION GLOVES (LATEX)
  960. K863920WAKO(TM) ZN TEST
  961. K862803CHESEBROUGH POND'S HYDROCOLLOID DRESSING
  962. K192830Bright Temporary C&B
  963. K042065WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
  964. K051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
  965. K9450021X6YD, 2X6YD, 4X6YD ROLL BANDAGE
  966. K041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
  967. K072060QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
  968. K192773ALLIVE
  969. K855176TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
  970. K922094DISSECTION INSTRUMENT
  971. K053173DS CASSETTE
  972. K050852CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
  973. K922674NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
  974. K103223HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS
  975. K130453EXCELSIOR
  976. K955375EASYSTAT SODIUM/POTASSIUM ANALYZER
  977. K223819SI-Cure Sacroiliac Joint Fusion System
  978. K031825C.CAM
  979. K000428DIXI 2
  980. K940759FORTE ES
  981. K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…
  982. K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
  983. K062615VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
  984. K062132AVS PL PEEK SPACER SYSTEM
  985. K102244RELIANCE ENDOSCOPE PROCESSING SYSTEM
  986. K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…
  987. K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
  988. K931019BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE
  989. K182546Alphenix, INFX-8000H/B, V8.0
  990. K191680AZUR Vascular Plug
  991. K120217SONICSTIMU COMBO THERAPEUTIC DEVICE
  992. K140920SYNGO.CT COLONOGRAPHY
  993. K043528SPIROTEL
  994. K780052PROSTHESIS, DOUBLE CUP
  995. K243219MONARCH™ Platform (MON-000008)
  996. K853082OHMEDA 5120 OXYGEN MONITOR
  997. K844045ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
  998. K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
  999. K200180MTS Omadacycline 0.002 - 32 ug/mL
  1000. K884715ACHELASIA BALLOON DIALATOR

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