FDA 510(k) clearances — page 982

176,637 clearances on record, most recent first.

Clearances — page 982

98,101–98,200 of 176,637

K963334 — JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100Jamieson Film Co.·Product code IXX·1996-09-11
K941782 — VENTANA ANTI-CD5 PRIMARY ANTIBODYVentana Medical Systems, Inc.·Product code DEH·1996-09-10
K954350 — CARD GUARD MODEL CG-6500Card Guard Scientific Survival , Ltd.·Product code DXH·1996-09-10
K955628 — FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADSHeartstream, Inc.·Product code MKJ·1996-09-10
K960875 — KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)Sigma Diagnostics, Inc.·Product code JPA·1996-09-10
K961150 — DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULAHudson Respiratory Care, Inc.·Product code CCK·1996-09-10
K961420 — PROSTYLE COMPACTPlanmeca Oy·Product code EIA·1996-09-10
K961625 — QUATROLOC FEMORAL COMPONENT & HEADWhiteside Biomechanics, Inc.·Product code LPH·1996-09-10
K962026 — PREPOWDER VINYL PATIENT EXAMINATION GLOVESHong Huang Tang Industrial Co., Ltd.·Product code LYZ·1996-09-10
K962266 — 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATINGBiocompatibles Cardiovascular, Inc.·Product code DQX·1996-09-10
K962267 — PERFECTA PS REVISION STEMWrightmedicaltechnologyinc·Product code JDI·1996-09-10
K962342 — HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHMeadox Medicals, Div. Boston Scientific Corp.·Product code DXZ·1996-09-10
K962516 — TAP ANTI-SNORING DEVICENellcor Puritan Bennett, Inc.·Product code LRK·1996-09-10
K962664 — ELECTRA 1800C AUTOMATIC COAGULATION ANALYZERMedical Laboratory Automation Systems, Inc.·Product code GKP·1996-09-10
K962712 — YSANPOINT) (MENSTRUAL) DIGITAL TAMPONTalbot S. Lindstrom·Product code HEB·1996-09-10
K962895 — DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.·Product code JKC·1996-09-10
K963047 — AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)Fenwick Hearing Instruments·Product code ESD·1996-09-10
K963078 — STERI-OSS TEMPORARY IMPLANT CEMENTSteri-Oss, Inc.·Product code EMA·1996-09-10
K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY)Abbott Laboratories·Product code LFM·1996-09-10
K963181 — ELECSYS CALCHECK T UPDATEBoehringer Mannheim Corp.·Product code JJX·1996-09-10
K963191 — CEDIA ANTIBIOTIC TDM MULTI-CALSBoehringer Mannheim Corp.·Product code DKB·1996-09-10
K952882 — PERSONAL TELEMEDICINE SYSTEMAmerican Telecare, Inc.·Product code DXN·1996-09-09
K953974 — CAMVISION 1000Medivision Medical Imaging, Ltd.·Product code JAA·1996-09-09
K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, Inc.·Product code JQB·1996-09-09
K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8FIdeas For Medicine, Inc.·Product code MJN·1996-09-09
K961023 — AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)Accuimage, Inc.·Product code LMD·1996-09-09
K962118 — DSL ACTIVE FSH IRMADiagnostic Systems Laboratories, Inc.·Product code CGJ·1996-09-09
K962260 — REAL-TIME VIDEO CONTRAST ENHANCERDigivision, Inc.·Product code LLZ·1996-09-09
K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIPAmerican White Cross, Inc.·Product code LWF·1996-09-09
K962469 — ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYAmerican Laboratory Products Co., Ltd.·Product code MID·1996-09-09
K962487 — BREAST TREATMENT AID M200S. and H. Engineering, Inc.·Product code IYE·1996-09-09
K962698 — ACUTEK'S CLEARPASAGEAcutek Adhesive Specialties, Inc.·Product code LWF·1996-09-09
K962798 — AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDSHearing Solutions, Inc.·Product code ESD·1996-09-09
K962961 — SUSTAINED PHONATIONSurface Mount Technology, Inc.·Product code KTH·1996-09-09
K963033 — BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIESOlympus America, Inc.·Product code EOQ·1996-09-09
K963346 — STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3Consolidated Technologies, Inc.·Product code JJY·1996-09-09
K960457 — ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2CMed Labs, Inc.·Product code IPF·1996-09-06
K961075 — MEDCARE REGIONAL ANETHESIA KITMedcare Medical Group, Inc.·Product code CAZ·1996-09-06
K961832 — BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVERBlue Ridge Medical, Inc.·Product code CCW·1996-09-06
K962403 — NOBLEPHARMA WIDE ACCESSORIESNobelpharma USA, Inc.·Product code DZE·1996-09-06
K962449 — OSTEO COMPACTION KITSteri-Oss, Inc.·Product code DZE·1996-09-06
K962614 — SHIFA STERILE DISPOSABLE SYRINGESInternational Regulatory Consultants·Product code FMF·1996-09-06
K962644 — VIGOR COMPRESSION HIP SCREW SYSTEMDeutschland Surgical, Inc.·Product code JDO·1996-09-06
K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641Medi-Flex Hospital Products, Inc.·Product code KMF·1996-09-06
K962741 — TRI-PHASIX CHROMATIC ALGINATEParkell, Inc.·Product code ELW·1996-09-06
K962851 — ACRYNOODLES ABSORBENT WOUND DRESSINGAcrymed, Inc.·Product code MGQ·1996-09-06
K963122 — UNITRON MODEL ICON KRUnitron Industries, Inc.·Product code ESD·1996-09-06
K963134 — DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)Igenics, Inc.·Product code EFQ·1996-09-06
K955887 — NEWMED ABP-LITENewmed Corp.·Product code DXW·1996-09-05
K960578 — ELVIS HSV GOLDDiagnostic Hybrids, Inc.·Product code GQN·1996-09-05
K960860 — GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3Greiner America, Inc.·Product code JKA·1996-09-05
K961105 — SKIN DOSE MONITORMcmahon Medical·Product code OWB·1996-09-05
K961261 — DYNATRON 525Dynatronics Corp.·Product code LIH·1996-09-05
K961525 — ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)Mri Devices Corp.·Product code MOS·1996-09-05
K961594 — BETTER-VENTERCirculatory Technology, Inc.·Product code DWF·1996-09-05
K961628 — MINI FLEX COILW. L. Gore & Associates, Inc.·Product code MOS·1996-09-05
K961969 — HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWAREHitachi Medical Systems America, Inc.·Product code LNH·1996-09-05
K961985 — ELECT BLOOD GLUCOSE MONITORIG SYSTEMSelfcare, Inc.·Product code CGA·1996-09-05
K962237 — THUMPER CARDIOPULMONARY RESUSCITATORMichigan Instruments, Inc.·Product code DRM·1996-09-05
K962275 — MAICO MA25 SERIES II WITH SPEECHBernafon-Maico, Inc.·Product code EWO·1996-09-05
K962300 — CLAMPLESS VALVED CATHETERBmw Medical, Inc.·Product code LJS·1996-09-05
K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.·Product code BSR·1996-09-05
K962484 — SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)Synthes (Usa)·Product code KTT·1996-09-05
K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.·Product code JZT·1996-09-05
K962710 — GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENSGelflex Laboratories·Product code LPL·1996-09-05
K962711 — GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENSGelflex Laboratories·Product code LPL·1996-09-05
K962910 — SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFYUni-Patch, Inc.·Product code GZJ·1996-09-05
K963152 — RIONET HB-55ASAuthorized Hearing Systems, Inc.·Product code ESD·1996-09-05
K963153 — RIONET HB-55SAuthorized Hearing Systems, Inc.·Product code ESD·1996-09-05
K963154 — RIONET HB-54ASAuthorized Hearing Systems, Inc.·Product code ESD·1996-09-05
K955788 — IMNI HOT PACKSOmni Therm, Inc.·Product code IMD·1996-09-04
K960194 — MYELOTEC MYELOSCOPEMyelotec, Inc.·Product code HRX·1996-09-04
K961053 — SERAQUEST RUBELLA IGGQuest Intl., Inc.·Product code LFX·1996-09-04
K961176 — OMNI COLD GEL PACKSOmni Therm, Inc.·Product code IMD·1996-09-04
K961597 — GATED MIBI 3-D EJECTION FRACTION PROCESSINGTrionix Research Laboratory, Inc.·Product code KPS·1996-09-04
K961991 — ACL 6000 SYSTEM (ACL 6000)Instrumentation Laboratory CO·Product code GKP·1996-09-04
K962177 — BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KITC.R. Bard, Inc.·Product code DSP·1996-09-04
K962375 — MICROVASIVE BALLOON GASTROSTOMY TUBE KITBoston Scientific Corp·Product code KNT·1996-09-04
K962519 — EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORSBehring Diagnostics, Inc.·Product code LCD·1996-09-04
K962595 — KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONSKARL STORZ Endoscopy-America, Inc.·Product code FFS·1996-09-04
K962618 — GYREX V-EPElscint, Inc.·Product code LNH·1996-09-04
K950025 — SELF PROPELLED ROBOTIC WHEEL (SPRW)Datatran, Inc.·Product code ITI·1996-09-03
K960785 — LFS LIPOGEL ASSAY KITZaxis, Inc.·Product code JHO·1996-09-03
K961410 — DURASIL (MODIFICATION)The S. F. Group, Inc.·Product code MDA·1996-09-03
K962192 — SUNRISE CURING LAMPSunrise Technologies, Inc.·Product code EBF·1996-09-03
K962242 — SURESCANClinicon Corp.·Product code GEX·1996-09-03
K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENTIntermedics Orthopedics·Product code KWT·1996-09-03
K962377 — 3D-SPINESkill Technologies, Inc.·Product code KQX·1996-09-03
K962383 — PULPDENT RESILUTE IIPulpdent Corp.·Product code EMA·1996-09-03
K962401 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLESW. L. Gore & Associates, Inc.·Product code FTL·1996-09-03
K962439 — DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc.·Product code MGQ·1996-09-03
K962496 — SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)Tissue Technologies, Inc.·Product code FTL·1996-09-03
K962616 — SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMSynthes (Usa)·Product code HRS·1996-09-03
K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODEUnimed Surgical Products, Inc.·Product code GEI·1996-09-03
K962946 — ORTHO-ONEBisco, Inc.·Product code DYH·1996-09-03
K963093 — SIREMOBIL COMPACTSiemens Medical Solutions USA, Inc.·Product code OXO·1996-09-03
K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIESElias U.S.A., Inc.·Product code LYR·1996-08-30
K954607 — RETICULOCYTE METHODBayer Corp.·Product code GKL·1996-08-30
K955586 — ROBISON & SMITH SURGICAL PACKSRobison & Smith, Inc.·Product code FYA·1996-08-30
K955895 — E. HISTOLYTICA TESTTechlab, Inc.·Product code KHW·1996-08-30

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