FDA 510(k) clearances — page 885

176,637 clearances on record, most recent first.

Clearances — page 885

88,401–88,500 of 176,637

K984182 — PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452Possis Medical, Inc.·Product code DSY·1999-02-01
K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451Possis Medical, Inc.·Product code DYF·1999-02-01
K984233 — C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINEFresenius Hemotechnology, Inc.·Product code CAC·1999-02-01
K984275 — THE GOLDEN TIP ELECTRO-SURGICAL PROBEAmada Surgical·Product code GEI·1999-02-01
K984291 — CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENTImplex Corp.·Product code JWH·1999-02-01
K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEMHowmedica, Inc.·Product code HSB·1999-02-01
K984488 — SHEER THINTwe Companies, Inc.·Product code HIS·1999-02-01
K990095 — STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEMInfluence, Inc.·Product code MBI·1999-02-01
K990120 — MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEDepuy Ace Medical Co.·Product code HSB·1999-02-01
K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKEROsteonics Corp.·Product code MNI·1999-02-01
K982328 — BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.·Product code CJO·1999-01-29
K982346 — ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEMAngioDynamics, Inc.·Product code FGE·1999-01-29
K982947 — BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENSOcular Sciences Puerto Rico, Inc.·Product code LPL·1999-01-29
K983029 — POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001Tpc Advanced Technology, Inc.·Product code ELC·1999-01-29
K983289 — APOLIPOPROTEIN A1Abbott Laboratories·Product code DER·1999-01-29
K983674 — VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSOrtho-Clinical Diagnostics, Inc.·Product code JMM·1999-01-29
K983858 — SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESSims Portex, Inc.·Product code MIA·1999-01-29
K983868 — OPMI TWINER SURGICAL MICROSCOPECarl Zeiss, Inc.·Product code GEX·1999-01-29
K983878 — CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPEE. Benson Hood Laboratories, Inc.·Product code EOQ·1999-01-29
K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESHowmedica, Inc.·Product code JEY·1999-01-29
K983900 — VENOMETERAdvanced Medical Technology , Ltd.·Product code JOM·1999-01-29
K983915 — AMPLAID A315 AND A319Amplifon S.P.A.·Product code EWO·1999-01-29
K983966 — NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSANDentsply Intl.·Product code EJR·1999-01-29
K984055 — CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERSSims Deltec, Inc.·Product code FOZ·1999-01-29
K984152 — SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENTBeckman Coulter, Inc.·Product code DJG·1999-01-29
K984369 — DCI ENDOSCOPEKARL STORZ Endoscopy-America, Inc.·Product code EOB·1999-01-29
K984402 — SYNCHRON SYSTEMS AMMONIA (AMM) REAGENTBeckman Coulter, Inc.·Product code JIF·1999-01-29
K984477 — LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529Bio-Rad·Product code JJY·1999-01-29
K984481 — EXHALATION VALVEIntersurgical, Inc.·Product code CBP·1999-01-29
K984626 — ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5Bio-Rad·Product code JJX·1999-01-29
K990026 — VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.·Product code JJX·1999-01-29
K990092 — AVL OMNI MODULAR ANALYZERAvl Scientific Corp.·Product code CHL·1999-01-29
K990125 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. KHewlett-Packard GmbH·Product code DSI·1999-01-29
K973227 — ASKINA HYDROCOLLOID/THINB.Braun Medical, Inc.·Product code KMF·1999-01-28
K981480 — PHILIPS EASYGUIDEPhilips Medical Systems, Inc.·Product code HAW·1999-01-28
K981676 — CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.·Product code KWP·1999-01-28
K981729 — IS-RUBELLA IGG TEST SYSTEMDiamedix Corp.·Product code LFX·1999-01-28
K982493 — COMPEED PSORIASIS DRESSINGColoplast Corp.·Product code FRO·1999-01-28
K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.·Product code KTN·1999-01-28
K983560 — INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENERInnovasive Devices, Inc.·Product code MBI·1999-01-28
K983592 — SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWSSulzer Orthopedics, Inc.·Product code HWC·1999-01-28
K983655 — AUTOSTAT II ANA SCREEN ELISACogent Diagnotics , Ltd.·Product code LJM·1999-01-28
K983774 — UALBAbbott Laboratories·Product code JIR·1999-01-28
K983851 — CAPELLA COCHLEAR EMISSIONS ANALYZERMadsen Electronics, Inc.·Product code EWO·1999-01-28
K983852 — BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429Geiger Medical Technologies, Inc.·Product code GEI·1999-01-28
K984021 — MS300Lsi Intl., Inc.·Product code IPF·1999-01-28
K984082 — BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKETEmox 911 CC·Product code MGQ·1999-01-28
K984107 — RDI DIRECT LDL CHOLESTEROL TESTReference Diagnostics, Inc.·Product code MRR·1999-01-28
K984113 — MS400Lsi Intl., Inc.·Product code IPF·1999-01-28
K984132 — IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5Diagnostic Products Corp.·Product code DCK·1999-01-28
K984137 — QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISAInova Diagnostics, Inc.·Product code MVM·1999-01-28
K984158 — P.F.C. MODULAR PLUS OFFSET TIBIAL TRAYDepuy, Inc.·Product code JWH·1999-01-28
K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENTOrtho-Clinical Diagnostics, Inc.·Product code LBR·1999-01-28
K984320 — BIOABSORBABLE INTERFERENCE SCREWSSmith & Nephew, Inc.·Product code HWC·1999-01-28
K984354 — MECHANICAL WHEELCHAIRColours 'N Motion·Product code IOR·1999-01-28
K984367 — ACTIVXAdorno Rogers Technology·Product code IOR·1999-01-28
K984448 — BIRCOLL BALLOON DISSECTORWells Johnson Co.·Product code FZW·1999-01-28
K984459 — DEPUY PROFILE FEMORAL HIP WITH POROCOATDePuy Orthopaedics, Inc.·Product code LPH·1999-01-28
K984529 — HEMOCHEK SAMPLE COLLECTION KITOsborn Laboratories, Inc.·Product code LCP·1999-01-28
K990059 — OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONSHowmedica Osteonics Corp.·Product code MNI·1999-01-28
K990161 — ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01Bio-Rad·Product code JJY·1999-01-28
K990162 — ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01Bio-Rad·Product code JJX·1999-01-28
K972065 — AURORANeurovena Corp.·Product code DQY·1999-01-27
K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)Wembley Rubber Products (M) Sdn Bhd·Product code LYY·1999-01-27
K981359 — GT LEGGIEROTerumo Medical Corp.·Product code DQY·1999-01-27
K982095 — LACTOSORB MENISCAL REPAIR DEVICEBiomet, Inc.·Product code MAI·1999-01-27
K982242 — INVACARE CPAPInvacare Corp.·Product code BZD·1999-01-27
K982384 — MERCATORHarley Street Software , Ltd.·Product code DSH·1999-01-27
K982500 — CHAIT CECOSTOMY CATHETERCook, Inc.·Product code KNT·1999-01-27
K982506 — VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEMCryosurgery, Inc.·Product code GEH·1999-01-27
K982540 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,Cardiac Pathways Corp.·Product code MTD·1999-01-27
K982819 — ENDIUS SPINE ENDOSCOPEEndius, Inc.·Product code GWG·1999-01-27
K983100 — KAVO KEY LASER 1242Kavo America·Product code GEX·1999-01-27
K983988 — SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATESyntec Scientific Corp.·Product code HRS·1999-01-27
K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)Wembley Rubber Products (M) Sdn Bhd·Product code LYY·1999-01-26
K982090 — PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEMPaceart, Inc.·Product code DXH·1999-01-26
K982178 — VAGABOND SOFT RESTRAINT SYSTEMEmergent Innovations, Ltd.·Product code FMQ·1999-01-26
K982488 — BICON BONE SCREW SYSTEMBicon, Inc.·Product code DZE·1999-01-26
K983145 — TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)Shen Wei (Usa), Inc.·Product code LYY·1999-01-26
K983281 — APOBAbbott Laboratories·Product code DFC·1999-01-26
K983799 — MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICLMedtronic PS Medical·Product code GWM·1999-01-26
K983809 — KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTORKLS-Martin L.P.·Product code MQN·1999-01-26
K983912 — VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKERVistakon, Johnson & Johnson Vision Products, Inc.·Product code LPL·1999-01-26
K983992 — NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAYNichols Institute Diagnostics·Product code JZO·1999-01-26
K984013 — PLANMECA INTRACAM STATIONPlanmeca Oy·Product code EIA·1999-01-26
K984260 — PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)Terumo Medical Corp.·Product code DYB·1999-01-26
K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDESOrtho-Clinical Diagnostics, Inc.·Product code DLZ·1999-01-26
K990149 — ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01Bio-Rad·Product code JJY·1999-01-26
K990150 — ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01Bio-Rad·Product code JJY·1999-01-26
K981954 — VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTSHealthline Implants, Inc.·Product code NRQ·1999-01-25
K982264 — FIRSTSAVE BIPHASIC MODELS 9200 AND 9210Survivalink Corp.·Product code MKJ·1999-01-25
K982432 — PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-Tinnitus Treatment Centers, Inc.·Product code KLW·1999-01-25
K982568 — BLADDERMANAGER PCI 5000 MODEL 1002Diagnostic Ultrasound Corp.·Product code ITX·1999-01-25
K983782 — ELECTROSURGICAL DISPERSIVE ELECTRODEConmedcorp·Product code GEI·1999-01-25
K983832 — INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETERIdem (Int'L Dist. of Electronics For Medicine)·Product code ETY·1999-01-25
K983905 — KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600Eastman Kodak Company·Product code LMC·1999-01-25
K984045 — RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYSKamiya Biomedical Co.·Product code DHR·1999-01-25
K984069 — ENTAXIS NASAL PACKINGLes Laboratorires Brothier, S.A.·Product code EMX·1999-01-25
K984127 — POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILEKilang Barangan Getah Dioh·Product code LYY·1999-01-25
K984252 — IMATION TRIMATIC DIGITAL SYSTEMImation Corp.·Product code LMA·1999-01-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.