FDA 510(k) clearances — page 862

176,637 clearances on record, most recent first.

Clearances — page 862

86,101–86,200 of 176,637

K972833 — E100M VENTILATOR (E100M)Newport Medical Instruments, Inc.·Product code CBK·1999-09-23
K990241 — ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIPAccuimage Diagnostics Corp.·Product code LLZ·1999-09-23
K990660 — NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XXNmt Neurosciences Implants S.A.·Product code JXG·1999-09-23
K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)Perimed, Inc.·Product code LKD·1999-09-23
K991551 — VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JKA·1999-09-23
K991646 — AGILITY STEERABLE GUIDEWIRECordis Neurovascular, Inc.·Product code DQX·1999-09-23
K992026 — SORING GMBH, SONOCA 300Soring GmbH Medizintechnik·Product code BTA·1999-09-23
K992153 — PE-PLUS ACETABULAR CUPPlus Orthopedics·Product code JDI·1999-09-23
K992159 — SURGISIS SLINGCook Biotech, Inc.·Product code PAG·1999-09-23
K992168 — MOSS MIAMI 6.35MM POLYAXIAL SCREWDepuyacromed·Product code KWQ·1999-09-23
K992270 — MIRACLEBREATH TONGUE CLEANERStellar Labs, Inc.·Product code LCN·1999-09-23
K992282 — MICRO-FRANCE LIPOSUCTION CANNULASXomed, Inc.·Product code QPB·1999-09-23
K992348 — SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)Synthes (Usa)·Product code JDS·1999-09-23
K992367 — EBI XFIX DYNAFIX SYSTEM HA COATED SCREWSElectro-Biology, Inc.·Product code HWC·1999-09-23
K992474 — ARTHROSCOPE / MEDIFIX INC.Medifix, Inc.·Product code HRX·1999-09-23
K992480 — MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPESMedifix, Inc.·Product code HET·1999-09-23
K992565 — A-18 HEMODIALYZERAlthin Medical AB·Product code FJI·1999-09-23
K992577 — PHOTON RADIOSURGERY SYSTEM (PRS)Photoelectron Corporation·Product code JAD·1999-09-23
K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·Product code GKZ·1999-09-23
K992938 — ROTORBLADE SUTURE ANCHORLi Medical Technologies, Inc.·Product code MAI·1999-09-23
K991209 — ORAL SLEEP DISORDER AIDPerl-Rad Sleep Disorder Lab·Product code LRK·1999-09-22
K991398 — BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KITStryker Leibinger·Product code GXP·1999-09-22
K991577 — NIC TONE ACRYLIC RESINSManufacturera Dental Continental·Product code EBI·1999-09-22
K992144 — BIOPRO RIMMED ACETABULAR COMPOMENTBiologically Oriented Prostheses·Product code LZO·1999-09-22
K992161 — CERANANordiska Dental AB·Product code EIH·1999-09-22
K992306 — SAMSUNG RAYPAX DISPLAY WORKSTATIONSamsung Sds Co., Ltd.·Product code LLZ·1999-09-22
K992350 — PYLON INTRAMEDULLAARY NAIL SYSTEMAlphatec Mfg., Inc.·Product code HSB·1999-09-22
K992364 — HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS OPamitex Industries Sdn Bhd·Product code LYY·1999-09-22
K992374 — AURORA HLPremier Laser Systems, Inc.·Product code GEX·1999-09-22
K992405 — AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)Axya Medical, Inc.·Product code GAW·1999-09-22
K992518 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEMDentsply Intl.·Product code EBC·1999-09-22
K992609 — HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400Kay See Dental Mfg. Co.·Product code EBI·1999-09-22
K992611 — MITEK ROTATOR CUFF QUICKANCHOR PLUSMitek Products·Product code HWC·1999-09-22
K992645 — SINFONYEspe Dental AG·Product code EBF·1999-09-22
K992705 — CERADIUM NON-PRECIOUS CERAMIC ALLOYMatech, Inc.·Product code EJH·1999-09-22
K992951 — CONVERTORS SURGICAL GOWNSAllegiance Healthcare Corp.·Product code FYA·1999-09-22
K993069 — GE DIASONICS GATEWAY AND GATEWAY FXGeneral Electric Co.·Product code IYO·1999-09-22
K991045 — MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.·Product code GWK·1999-09-21
K991062 — QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024Immunetics, Inc.·Product code LSR·1999-09-21
K991063 — QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024Immunetics, Inc.·Product code LSR·1999-09-21
K991319 — RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALSOrfit Industries·Product code IYE·1999-09-21
K991399 — RADIONICS MICROELECTRODE KITRadionics, Inc.·Product code GXI·1999-09-21
K992199 — ACID HEMOGLOBIN KITHelena Laboratories·Product code JBD·1999-09-21
K992296 — PASCO MIC AND MIC/ID PANELS, VANCOMYCINPasco Laboratories, Inc.·Product code JWY·1999-09-21
K992423 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500Dade Behring, Inc.·Product code GKP·1999-09-21
K992440 — AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISACogent Diagnotics , Ltd.·Product code MID·1999-09-21
K992487 — MITEK MINI QUICKANCHOR PLUSMitek Products·Product code HWC·1999-09-21
K992528 — BIOCHECK IGE ELISA, MODEL BC-1035Biocheck, Inc.·Product code DGC·1999-09-21
K992763 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500Dade Behring, Inc.·Product code GKP·1999-09-21
K992928 — CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.·Product code MNI·1999-09-21
K992947 — CANNULATED SMARTSCREW MODELS 224540C, 224570CBionx Implants, Ltd.·Product code HWC·1999-09-21
K992963 — I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401International Isotopes, Inc.·Product code KXK·1999-09-21
K990378 — STATVIEW SYSTEMData Critical Corp.·Product code MSX·1999-09-20
K992124 — AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTIAvanti Polar Lipids, Inc.·Product code GMQ·1999-09-20
K992370 — AMPLAID A724 AND A728Amplifon S.P.A.·Product code ETY·1999-09-20
K992559 — HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010Jostra Bentley·Product code DTZ·1999-09-20
K992990 — QUICKPAC II ONE STEP COCAINE TESTSyntron Bioresearch, Inc.·Product code DIO·1999-09-20
K983097 — TENS/FES/NMES ELECTRODESUni-Patch, Inc.·Product code GXY·1999-09-17
K983410 — @ TARGETBrainlab AG·Product code HAW·1999-09-17
K984358 — OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597Olympus America, Inc.·Product code FDS·1999-09-17
K990194 — BIOBUTTONLinvatec Corp.·Product code HWC·1999-09-17
K990362 — INSTRUMENT, ULTRASONIC, SCALPELEthicon Endo-Surgery, Inc.·Product code GEI·1999-09-17
K990641 — CALTAG FETAL HEMOGLOBIN TESTCaltag Laboratories, Inc.·Product code GHQ·1999-09-17
K990810 — ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGMaersk Medical, Ltd.·Product code FRO·1999-09-17
K991480 — EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIPSelfcare, Inc.·Product code CGA·1999-09-17
K991532 — DRX QT. HCGMetrika, Inc.·Product code DHA·1999-09-17
K991927 — MEDI-TEST COMBI 11Macherey-Nagel-Duren·Product code JIL·1999-09-17
K991974 — FUTURA GLASS IONOMER SILVER REINFORCEDAb Ardent·Product code EMA·1999-09-17
K991998 — GAMMA-B 25-HYDROXY VITAMIN D RIAImmunodiagnostic Systems , Ltd.·Product code MRG·1999-09-17
K992094 — GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.·Product code NAE·1999-09-17
K992106 — MODUS SYSTEM SELF-DRILLING SCREWSMedartis AG·Product code HWC·1999-09-17
K992129 — PHAZX VLD-100Phazx Systems, Inc.·Product code GZO·1999-09-17
K992321 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000Dade Behring, Inc.·Product code GKP·1999-09-17
K992381 — CO2 GAS WARMER II, MODEL 6-800-00Northgate Technologies, Inc.·Product code HIF·1999-09-17
K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KITThe Binding Site, Ltd.·Product code DAE·1999-09-17
K992670 — OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067Instrumentation Industries, Inc.·Product code CBK·1999-09-17
K992772 — CARDIOPHONICS 1000 MEMORY MONITORRlt Medical Assoc., Inc.·Product code DXH·1999-09-17
K992873 — LORENZ EXTERNAL MANDIBULAR DISTRACTORWalter Lorenz Surgical, Inc.·Product code MQN·1999-09-17
K992903 — COLOR BUFFED CEMENTED FEMORALBiomet, Inc.·Product code JDI·1999-09-17
K981047 — FRESH AIRColorado Medtech, Inc.·Product code CAW·1999-09-16
K983717 — BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEMAerotel Medical Systems (1998) , Ltd.·Product code DXN·1999-09-16
K984573 — OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROPAlcon Laboratories·Product code LPN·1999-09-16
K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METEREchocath, Inc.·Product code JOP·1999-09-16
K992143 — MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)Pasco Laboratories, Inc.·Product code JWY·1999-09-16
K992788 — BEAR CUB 750 PSVBear Medical Systems, Inc.·Product code CBK·1999-09-16
K992839 — SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSEHeinz Kurz GmbH Medizintechnik·Product code ETB·1999-09-16
K992892 — STEPPING KINEMATIC IMAGING PLATFORM (SKIP)Magnetic Moments, LLC·Product code LNH·1999-09-16
K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.·Product code DRO·1999-09-15
K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.·Product code DRO·1999-09-15
K983762 — NUCLISENS CMV PP67Organon Teknika Corp.·Product code LIN·1999-09-15
K991883 — REDI-TEST OPIATESAdvantage Diagnostics Corp.·Product code DJG·1999-09-15
K992072 — BOLUS ACCESSORY SETI-Flow Corp.·Product code FPA·1999-09-15
K992268 — NAC PRN NEEDLELESS ACCESS CONNECTORThe Kipp Group·Product code FPA·1999-09-15
K992399 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.·Product code CIX·1999-09-15
K992475 — CARESIDE CO2, TOTALCareside, Inc.·Product code KHS·1999-09-15
K992755 — CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBECordis, A Johnson & Johnson Co.·Product code FGE·1999-09-15
K992814 — CYNOSURE ACCOLADE LASERCynosure, Inc.·Product code GEX·1999-09-15
K992825 — CORDIS EXTREME PTA BALLOON CATHETERCordis Corp.·Product code LIT·1999-09-15
K992910 — AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)Medtronic Vascular·Product code DTZ·1999-09-15
K972267 — HELICA TCTenerco, Inc.·Product code GEI·1999-09-14

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