FDA 510(k) clearances — page 1087

176,637 clearances on record, most recent first.

Clearances — page 1087

108,601–108,700 of 176,637

K941225 — UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENTBaxter Healthcare Corp·Product code DTZ·1994-08-16
K941453 — CHECK VALVE SOLUTION SETDouglas Medical Products Corp.·Product code FPA·1994-08-16
K941615 — AXSYM VALPROIC ACIDAbbott Laboratories·Product code LEG·1994-08-16
K942377 — TRANSTAR PRESSURE TRANSDUCERMedex, Inc.·Product code DPT·1994-08-16
K942566 — IMX ULTRASENSISTIVE HTSH IIAbbott Laboratories·Product code JLW·1994-08-16
K943159 — LIFE CLIP AND LIFE CLIP APPLIERLife Surgery, Inc.·Product code FZP·1994-08-16
K943501 — SUNGLASSES AND SPORT SUNGLASSESSino-World Champion Co., Ltd.·Product code HQY·1994-08-16
K924010 — REDINOV PERFUSION SETBipress, Inc.·Product code FPA·1994-08-15
K934959 — MODEL 118 FETAL/MATERNAL MONITORGe Medical Systems Information Technologies·Product code HGM·1994-08-15
K935137 — TEFGEN-FDAmerican Custom Medical, Inc.·Product code NPK·1994-08-15
K935987 — FLEXTRANSBaxter Diagnostics, Inc.·Product code JSM·1994-08-15
K936000 — PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATIONPuritan Bennett Corp.·Product code BTT·1994-08-15
K936269 — CASPAR TITANIUM ALLOY BONE SCREWSAesculap, Inc.·Product code KWQ·1994-08-15
K940446 — 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)Minnesota Mining and Mfg. Co.·Product code FRN·1994-08-15
K941235 — VISTA B12 ASSAYSyva Co.·Product code CDD·1994-08-15
K941841 — SMARTSCANLaserscope·Product code GEX·1994-08-15
K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERSIcor AB·Product code BYD·1994-08-15
K942597 — CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATORHolmed Corp.·Product code GCJ·1994-08-15
K942612 — KARL STORZ WOUND CLOSURE INSTRUMENTSKARL STORZ Endoscopy-America, Inc.·Product code GCJ·1994-08-15
K942627 — 454A ELECTROSURGICAL ANALYZERHogan & Hartson·Product code GEI·1994-08-15
K942650 — BIG BENRud Riester GmbH & CO KG·Product code DXN·1994-08-15
K942887 — MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEMHewlett-Packard Co.·Product code HGM·1994-08-15
K943263 — NILSing Wah International Enterprises , Ltd.·Product code HQY·1994-08-15
K943656 — ALPHA SOLAR SYSTEM TANNING BEDHeartland Tan Systems·Product code LEJ·1994-08-15
K932041 — XANCHOR SUTURE ATTACHMENT DEVICEOrthopaedic Biosystems·Product code JDR·1994-08-12
K941812 — SLICESMicrosignal Corp.·Product code LNH·1994-08-12
K942219 — ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALSRobert W. Bauer & Assoc., Inc.·Product code ELW·1994-08-12
K942789 — MISTASSISTThe Merlin Corp.·Product code LRD·1994-08-12
K943475 — ULTRA HYDROPHILIC ALGINAEEssential Dental Systems, Inc.·Product code ELW·1994-08-12
K921565 — CARDIOPULMONARY METABOLIC MEASUEMENT CARTQuiton Instrument Co.·Product code BZL·1994-08-11
K925701 — MINIPACK 911-STCPace Tech, Inc.·Product code CCK·1994-08-11
K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001Nk Biotechnical Engineering Co.·Product code LLN·1994-08-11
K940234 — CARPAL TUNNEL SYSTEMRichard Wolf Medical Instruments Corp.·Product code HRX·1994-08-11
K940547 — FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATEDJ-Lloyd Medical, Inc.·Product code DYG·1994-08-11
K940896 — MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICEMedex, Inc.·Product code MAV·1994-08-11
K941197 — SILK*SKIN SCAR TREATMENTPuritas Health Care, Inc.·Product code MDA·1994-08-11
K941343 — SPINAL ANESTHESIA TRAYSpinal Specialties, Inc.·Product code CAZ·1994-08-11
K941950 — OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360Baxter Healthcare Corp·Product code GCJ·1994-08-11
K943490 — CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSESContinental Soft Lens, Inc.·Product code LPL·1994-08-11
K943568 — FACONNABLE EYEWEAR (SUNGLASSES)Blink Designs, Inc.·Product code HQY·1994-08-11
K943609 — SUNGLASSESKonwan Optical Xiamen Co., Ltd.·Product code HQY·1994-08-11
K943617 — DISPOSABLE MANUAL RESUSCITATORPuritan-Bennett·Product code BTM·1994-08-11
K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSY·Product code FPA·1994-08-10
K934385 — MINIPACK 3100/3000 MODIFICATIONPace Tech, Inc.·Product code DXN·1994-08-10
K935264 — CHILDREN'S SUNGLASSESAgglo Corp. , Ltd.·Product code HQY·1994-08-10
K935625 — ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDEWallace A. Erickson & Co.·Product code DYH·1994-08-10
K941020 — DRUG RECONSTITUTION FILTER DEVICEGelman Sciences, Inc.·Product code FMF·1994-08-10
K941716 — MICRODONTIC LENSNew Image Industries, Inc.·Product code EIA·1994-08-10
K942203 — OTC DENTURE CLEANSERCombe, Inc.·Product code EFT·1994-08-10
K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLEMdt Corp., Inc.·Product code FQO·1994-08-10
K942666 — ORTHALGENAT IMPRESSION MATERIALDentauraum, Inc.·Product code ELW·1994-08-10
K943165 — CLEARFIL PHOTO BONDKuraray Company, Ltd.·Product code KLE·1994-08-10
K943166 — CLEARFIL LINER BOND SYSTEMKuraray Company, Ltd.·Product code KLE·1994-08-10
K943167 — CLEARFIL NEW BONDKuraray Company, Ltd.·Product code KLE·1994-08-10
K943168 — CLEARFIL AP-XKuraray Company, Ltd.·Product code EBF·1994-08-10
K943169 — CLEARFIL AP-X AND LINER BOND 2Kuraray Company, Ltd.·Product code EBF·1994-08-10
K943170 — CLEARFIL LINER BOND 2Kuraray Company, Ltd.·Product code KLE·1994-08-10
K943326 — SPECTACLE FRAMESBuffard-La-Doye·Product code HQZ·1994-08-10
K943487 — BIO74-PF CROWN & BRIDGE ALLOYJeneric/Pentron, Inc.·Product code EJT·1994-08-10
K943567 — FACONNABLE EYEWEARBlink Designs, Inc.·Product code HQZ·1994-08-10
K943624 — ELMED PNEUMOPERITONEUM NEEDLESHenke-Sass, Wolf GmbH·Product code FHO·1994-08-10
K923172 — ANAESTHESIA RECORD KEEPERDatex Division Instrumentarium Corp.·Product code BSZ·1994-08-09
K926321 — VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)Varian Assoc., Inc.·Product code IYE·1994-08-09
K931785 — BRANEMARK SYSTEM DRILL CONTROLLERNobelpharma USA, Inc.·Product code DZE·1994-08-09
K932208 — EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATMBaxter Healthcare Corp·Product code DWF·1994-08-09
K934303 — RFA A-300Scanditronix, Inc.·Product code IYE·1994-08-09
K935055 — ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)Roche Diagnostic Systems, Inc.·Product code DOE·1994-08-09
K935157 — ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESRegulatory Consultants TO the Medical Device Indus·Product code KPX·1994-08-09
K940178 — PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATIONDatascope Corp.·Product code DSP·1994-08-09
K940489 — SIMON NITINOL FILTERNitinol Medical Technologies, Inc.·Product code DTK·1994-08-09
K940667 — STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AIDStarkey Laboratories, Inc.·Product code ESD·1994-08-09
K941107 — THE CANAL (C.I.C.) AKA/HIDDEN EARQualitone, Inc.·Product code ESD·1994-08-09
K941219 — DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATORDupont Medical Products·Product code JIX·1994-08-09
K941325 — WATER IRRIGATOR, W1 200Strong Medical, Inc.·Product code KHH·1994-08-09
K942189 — CRYSTAL EARCrystal Care Intl., Inc.·Product code ESD·1994-08-09
K942335 — ACI SILICATH THORACIC CATHETERAmerican Catheter·Product code GBX·1994-08-09
K942841 — OEC 901Baldwin·Product code JAA·1994-08-09
K943337 — STANDUP WHEELCHAIRNestor Rehab Products , Ltd.·Product code IPL·1994-08-09
K943381 — LASER ALIGNMENT TOOLPhilips Medical Systems North America, Inc.·Product code IWE·1994-08-09
K943395 — PHILIPS M38 SERIESPhilips Hearing Instruments Co.·Product code ESD·1994-08-09
K943489 — DISPOSABLE SURGICAL TROCARApplied Medical Resources·Product code GCJ·1994-08-09
K943671 — GSI CANNULA REDUCER ACCESSORYGeneral Surgical Innovations·Product code GCJ·1994-08-09
K921846 — OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL RECOceania Health Care Systems, Inc.·Product code LNX·1994-08-08
K934495 — BRANEMARK SYSTEM(R) UCLA-TYPE ABUTMENT COMPLETENobelpharma AB·Product code DZE·1994-08-08
K934825 — BRANEMARK SYSTEMNobelpharma USA, Inc.·Product code DZE·1994-08-08
K934826 — BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104Nobelpharma USA, Inc.·Product code DZE·1994-08-08
K934827 — BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEMNobelpharma USA, Inc.·Product code DZE·1994-08-08
K942358 — AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERAM.P. Video, Inc.·Product code GCJ·1994-08-08
K942420 — IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANTKing & Spalding·Product code LZK·1994-08-08
K942421 — IMPLANTECH LATERAL MANDIBULAR BAR IMPLANTKing & Spalding·Product code LZK·1994-08-08
K942440 — AFP CARDIAC PACING SYSTEM MODEL 283Siemens-Pacesetter, Inc.·Product code DTB·1994-08-08
K943008 — BIOSCAN REAGENT STRIPSGenesis Labs, Inc.·Product code JJB·1994-08-08
K913255 — CERAMIC(TM) ABUTMENTCeramic Core Corp.·Product code DZE·1994-08-05
K920757 — FILTRAL HEMODIALYZERSC.G.H. Medical, Inc.·Product code KDI·1994-08-05
K932057 — BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACKBoard of Directors, Albert Browne , Ltd.·Product code JOJ·1994-08-05
K933542 — MESIAL LOOP BARGac Intl., Inc.·Product code ECO·1994-08-05
K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATEDKirschner Medical Corp.·Product code JWH·1994-08-05
K934468 — SLIP-ON FIXATION SPLINT (SFS)Gatewood Splints·Product code EHO·1994-08-05
K934781 — BVR HIGH TORQUE HEADSBvr Aero Precision Corp.·Product code EGS·1994-08-05
K935166 — FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCERMillar Instruments, Inc.·Product code DXO·1994-08-05

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