FDA 510(k) clearances — page 936

176,637 clearances on record, most recent first.

Clearances — page 936

93,501–93,600 of 176,637

K972693 — DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEARDeroyal Industries, Inc.·Product code HOZ·1997-09-30
K973407 — SUNGLASSES (NON-PRESCRIPTION)Pacific Optical Co. , Ltd.·Product code HQY·1997-09-30
K973490 — SUNGLASSESTong Yang Optical Co.·Product code HQY·1997-09-30
K964043 — COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORSCobe Cardiovascular, Inc.·Product code DTZ·1997-09-29
K970475 — MM-RUBYAmerican Lasers, Inc.·Product code GEX·1997-09-29
K971768 — RELIANT CHARGERWalling Medical Equipment Co.·Product code LKY·1997-09-29
K971794 — ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCEFrantz Design, Inc.·Product code LRK·1997-09-29
K972101 — SOLITAIREHeraeus Kulzer, Inc.·Product code KLE·1997-09-29
K972520 — OPTIVIEWOptimed Technologies, Inc.·Product code LLZ·1997-09-29
K972626 — ADVANCE KNEE SYSTEMWrightmedicaltechnologyinc·Product code JWH·1997-09-29
K972704 — KINEMATIC POSITIONERSGe Medical Systems, Inc.·Product code LNH·1997-09-29
K972731 — NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SETKlein-Baker Medical, Inc.·Product code KDJ·1997-09-29
K972865 — PROMEX ENT TISSUE REMOVAL SYSTEMPromex, Inc.·Product code ERL·1997-09-29
K972957 — SA-EF MULTI-LUMEN EXTENSION SETVlv Associates, Inc.·Product code FPA·1997-09-29
K973099 — PROSTATE SPECIFIC ANTIGEN CONTROLDade Chemistry Systems, Inc.·Product code JJX·1997-09-29
K973100 — PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORDade Chemistry Systems, Inc.·Product code JIT·1997-09-29
K973186 — IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGEDiagnostic Products Corp.·Product code DHB·1997-09-29
K973189 — RETINOL BINDING PROTEIN RBP RID KITThe Binding Site, Ltd.·Product code CZS·1997-09-29
K973256 — JIMMY JOHN III RECTAL NOZZLEColon Therapeutics·Product code KPL·1997-09-29
K973273 — XOMED T-STENT, FRONTAL SINUS STENTXomed, Inc.·Product code KAM·1997-09-29
K973286 — ENT IRRIGATING PUMP (70327700)Gyrus Ent LLC·Product code ERL·1997-09-29
K973451 — MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3Medical Analysis Systems, Inc.·Product code JJW·1997-09-29
K961848 — 3M LITTMANN ELECTRONIC STETHOSCOPEMinnesota Mining and Mfg. Co.·Product code DQD·1997-09-26
K962649 — SPORTROL RAPID STERILITY INDICATORNorth American Science Assoc., Inc.·Product code MTC·1997-09-26
K964541 — SANPO IKoike Medical Co.·Product code NFB·1997-09-26
K970216 — NITRILE EXAMINATION GLOVES-PRE POWDEREDInflux Pacific Sdn. Bhd.·Product code LZA·1997-09-26
K970253 — COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SETGambro Healthcare·Product code KDI·1997-09-26
K970688 — POCKET RESCUECheen Houng Ent. Co. , Ltd.·Product code KGB·1997-09-26
K970937 — MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)Mist, Inc.·Product code GCJ·1997-09-26
K971443 — RAPPORT V.T.D.Owen Mumford USA, Inc.·Product code LKY·1997-09-26
K971808 — SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIESMonarch Medical·Product code CAF·1997-09-26
K971979 — PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONSPlaytex Products, Inc.·Product code HIB·1997-09-26
K972438 — INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENERInnovasive Devices, Inc.·Product code MBI·1997-09-26
K972484 — ACS VIKING GUIDING CATHETERGuidant Corp.·Product code DQY·1997-09-26
K972487 — EMG RETRAINERChattanooga Group, Inc.·Product code HCC·1997-09-26
K972858 — KERR NEXUS ONE BOTTLE ADHESIVESybron Dental Specialties, Inc.·Product code KLE·1997-09-26
K973473 — ASLITexin Industrial (International) , Ltd.·Product code IOR·1997-09-26
K955497 — GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETCobe Renal Care, Inc.·Product code KDL·1997-09-25
K961751 — W.M.E. GPS 1001Weaver Medical Electronics, Inc.·Product code IPF·1997-09-25
K964406 — AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZERDaxor Corporation·Product code JWO·1997-09-25
K970061 — ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)Datascope Corp.·Product code DQA·1997-09-25
K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFMallinckrodt Medical·Product code JOH·1997-09-25
K971821 — UNICA 315 M CO2 SURGICAL LASER SYSTEMReliant Technologies, Inc.·Product code GEX·1997-09-25
K972199 — SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSISMarquette Electronics, Inc.·Product code DPS·1997-09-25
K972265 — A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZERTosoh Medics, Inc.·Product code LCP·1997-09-25
K972282 — SPACELABS MEDICAL PCIS PATIENT MONITORSSpacelabs Medical, Inc.·Product code DSI·1997-09-25
K972418 — HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)Heartstream, Inc.·Product code MKJ·1997-09-25
K972460 — OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)Osteonics Corp.·Product code JDI·1997-09-25
K972463 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYBiomedics·Product code JEY·1997-09-25
K972468 — NPB-195 PULSE OXIMETERNellcor Puritan Bennett, Inc.·Product code DQA·1997-09-25
K972725 — ALCOHOL REAGENT SETPointe Scientific, Inc.,·Product code DIC·1997-09-25
K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.·Product code CFL·1997-09-25
K972768 — BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEMBlackstone Medical, Inc.·Product code HRX·1997-09-25
K973055 — WAKO CH50 LINEARITY SETWako Chemicals USA, Inc.·Product code JIW·1997-09-25
K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITSynermed, Inc.·Product code CIG·1997-09-25
K973122 — QUICKSCREEN ONE STEP THC SCREENING TESTPhamatech·Product code LDJ·1997-09-25
K973143 — UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMAUniversal Reagents, Inc.·Product code GGP·1997-09-25
K973159 — ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOROratec Interventions, Inc.·Product code GEI·1997-09-25
K973204 — OSTEO BOS SYSTEM IN STAINLESS STEELOsteonics Corp.·Product code HRS·1997-09-25
K973209 — FRESH CELLS VERODiagnostic Hybrids, Inc.·Product code KIR·1997-09-25
K973210 — FRESH CELLS NCI H292Diagnostic Hybrids, Inc.·Product code KIR·1997-09-25
K973211 — FRESH CELLS MV1LUDiagnostic Hybrids, Inc.·Product code KIR·1997-09-25
K973212 — FRESH CELLS WI-38Diagnostic Hybrids, Inc.·Product code KIR·1997-09-25
K973213 — FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.·Product code KIR·1997-09-25
K973214 — FRESH CELLS HFFDiagnostic Hybrids, Inc.·Product code KIR·1997-09-25
K973379 — STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETSS. Jackson, Inc.·Product code FTM·1997-09-25
K973393 — CHEMMATE LCAVentana Medical Systems, Inc.·Product code DEH·1997-09-25
K973469 — QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELSConsolidated Technologies, Inc.·Product code JJY·1997-09-25
K973517 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJohnson & Johnson Clinical Diagnostics, Inc.·Product code JJY·1997-09-25
K971038 — KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULEKontron Instruments , Ltd.·Product code DPS·1997-09-24
K971256 — DUO-LITE PHOTOTHERAPY SYSTEMAir-Shields, Inc.·Product code LBI·1997-09-24
K971601 — OLYMPIC BILI-BASSINETOlympic Medical Corp.·Product code LBI·1997-09-24
K972377 — RI-MEGARudolf Riester GmbH & Co. KG·Product code DXQ·1997-09-24
K972378 — SANAPHON NRudolf Riester GmbH & Co. KG·Product code DXQ·1997-09-24
K972379 — PRECISA NRudolf Riester GmbH & Co. KG·Product code DXQ·1997-09-24
K972853 — CHOLESTEROL RAPID LIQUID REAGENTReagents Applications, Inc.·Product code CHH·1997-09-24
K972985 — SPLINT ITJeneric/Pentron, Inc.·Product code ELS·1997-09-24
K973035 — VIOLA II DENTAL CAMERA SYSTEMInnovative Medical Systems, Inc.·Product code EIA·1997-09-24
K973339 — DISETRONIC PENFINE INJECTION PEN NEEDLEDisetronic Medical Systems·Product code FMI·1997-09-24
K963071 — ANGIOMAT ILLUMENAMallinckrodt Inc., Liebel-Flarsheim Business·Product code DXT·1997-09-23
K964467 — SHELHIGH PERICARDIAL PATCHShelhigh, Inc.·Product code DXZ·1997-09-23
K970906 — PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSORDiametrics Medical, Ltd.·Product code CBZ·1997-09-23
K971150 — MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPEMist, Inc.·Product code GCJ·1997-09-23
K971229 — CAPNOXYGEN MASKMedsys, Inc.·Product code CCK·1997-09-23
K972360 — MULTISPECT 2 511 KEV COLLIMATORSiemens Medical Solutions USA, Inc.·Product code KPS·1997-09-23
K972361 — V40 ZIRCONIA FEMORAL HEADSHowmedica, Inc.·Product code LZO·1997-09-23
K972366 — IMNET DICOM NETWORK AGENTImnet Systems, Inc.·Product code LMD·1997-09-23
K972368 — FOTONA SKINLIGHT PLUS ND: YAG SYSTEMMedical Laser Solutions·Product code GEX·1997-09-23
K972397 — EZ SPRAYIntertex Research, Inc.·Product code CCQ·1997-09-23
K972399 — ADVANTAGE WINDOWS VOLUME RENDERING OPTIONGe Medical Systems, Inc.·Product code JAK·1997-09-23
K972426 — MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHImagyn Medical, Inc.·Product code HIH·1997-09-23
K972439 — ANORECTAL MANOMETRY ANALYSIS MODULEMedtronic-Synectics·Product code FFX·1997-09-23
K973266 — Z DEQ-IIElectone, Inc.·Product code ESD·1997-09-23
K970877 — IMMULITE CEADiagnostic Products Corp.·Product code DHX·1997-09-22
K970885 — ULTRASOUND SYSTEMS DRAPEProtek Medical Products, Inc.·Product code MMP·1997-09-22
K972436 — T1 LINE DENTAL HANDPIECESSiemens AG·Product code EFB·1997-09-22
K972462 — AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.·Product code LOJ·1997-09-22
K972580 — DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.·Product code JMM·1997-09-22
K972631 — ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDERIcs Medical Corp.·Product code GWN·1997-09-22
K972743 — SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENTSigma Diagnostics, Inc.·Product code CGX·1997-09-22

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