FDA 510(k) clearances — page 933

176,637 clearances on record, most recent first.

Clearances — page 933

93,201–93,300 of 176,637

K972353 — ERCO-RIBBONErcons, Inc.·Product code LKY·1997-10-28
K972829 — CRICKET 2000 RECORDING PULSE OXIMETERRespironics, Inc.·Product code DQA·1997-10-28
K972872 — DERMA K LASER SYSTEMEsc Medical Systems , Ltd.·Product code GEX·1997-10-28
K972905 — XPLAN-1Radionics Software Applications, Inc.·Product code IYE·1997-10-28
K973028 — HELIOS LASER IMAGER 1417Sterling Diagnostic Imaging, Inc.·Product code LMC·1997-10-28
K973090 — MEDSTATIONProgram S.R.L.·Product code LMD·1997-10-28
K973153 — UBI MAGIWEL AMPHETAMINE METABOLITESUnited Biotech, Inc.·Product code DJG·1997-10-28
K973155 — UBI MAGIWEL OPIATE METABOLITESUnited Biotech, Inc.·Product code DJG·1997-10-28
K973156 — UBI MAGIWEL COCAINE METABOLITESUnited Biotech, Inc.·Product code DJG·1997-10-28
K973422 — LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])Dejarnette Research Systems·Product code LMC·1997-10-28
K973431 — LASETTECell Robotics, Inc.·Product code GEX·1997-10-28
K973579 — AM SERIES HEARING AIDA & M Hearing, Ltd.·Product code ESD·1997-10-28
K973948 — DUALINE 100 BTEBernafon-Maico, Inc.·Product code ESD·1997-10-28
K970971 — URO MED NERVE STIMULATORUromed Corp.·Product code ETN·1997-10-27
K971259 — COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.·Product code KDH·1997-10-27
K971313 — NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SETNational Medical Care, Inc.·Product code FJK·1997-10-27
K971367 — BRAINSCAN CONFORMAL RT MODULEBrainlab AG·Product code IYE·1997-10-27
K972015 — HYDRAGEL 7,15,30, CHOL-HDL KITMorax·Product code LBT·1997-10-27
K972274 — SPIFEHelena Laboratories·Product code CEF·1997-10-27
K972918 — RAPID FIRE HAIR IMPLANTER CAROUSELApex Medical Products, LLC·Product code GAH·1997-10-27
K972923 — SUPER SILIPLUGS EAR PLUGSInterview Medical Technology Corp.·Product code EWD·1997-10-27
K972933 — VOX/BASE FOR WINDOWSJ-Mac System, Inc.·Product code LLZ·1997-10-27
K973043 — MODEL C-1 HEARING AIDBetter Hearing, Inc.·Product code ESD·1997-10-27
K973098 — COMPRESSION CERCLAGE GUNDOLF CCG-GFPlus Orthopedics·Product code JDQ·1997-10-27
K973234 — MIDAS TOUCH ELECTROSURGICAL ELECTRODEIti Medical Technologies, Inc.·Product code GEI·1997-10-27
K973310 — TBD* ONE-STEP OVULATION PREDICTOR TESTArmkel, LLC·Product code CEP·1997-10-27
K973352 — BRAND NAME *1-STEP PREGNANCYArmkel, LLC·Product code LCX·1997-10-27
K973832 — OPUS HLH CONTROLSBehring Diagnostics, Inc.·Product code JJX·1997-10-27
K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDPolymedica Industries, Inc.·Product code MGP·1997-10-24
K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMPCircon Video·Product code FEN·1997-10-24
K971018 — SMC ACETABULAR COMPONENTSignal Medical Corp.·Product code LPH·1997-10-24
K971588 — EVI SUTURED-CLIP APPLIERElective Vascular Intervention Inc. (Evi)·Product code FZP·1997-10-24
K971680 — AUTO SUTURE BONE WAXUnited States Surgical, A Division of Tyco Healthc·Product code MTJ·1997-10-24
K972028 — DERMASCAN SURGICAL LASER SCANNEREsc Medical Systems , Ltd.·Product code GEX·1997-10-24
K972471 — DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIESSmith & Nephew, Inc.·Product code GCJ·1997-10-24
K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)Wembley Rubber Products (M) Sdn Bhd·Product code KGO·1997-10-24
K972808 — HANSATOME MICROKERATOMEChiron Vision Corp.·Product code HNO·1997-10-24
K972867 — CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNITRocket Medical Plc·Product code ICX·1997-10-24
K973071 — TRI TALON RETRIEVAL FORCEPSMedical Engineering Laboratory, Inc.·Product code OCZ·1997-10-24
K973195 — TOTAL PERFORMANCE SYSTEM SHAVERStryker Endoscopy·Product code HRX·1997-10-24
K973466 — HANAULUX BLUE 75 AND HANAULUX BLUE 120Heraeus Med GmbH·Product code FSY·1997-10-24
K973574 — DURALASTIC ANATOMICAL MALAR IMPLANTHanson Medical, Inc.·Product code LZK·1997-10-24
K973654 — VIAL-MATE RECONSTITUTION DEVICE (2B8071)Baxter Healthcare Corp·Product code LHI·1997-10-24
K955243 — BARIAIRKinetic Concepts, Inc.·Product code FNM·1997-10-23
K962783 — EDEMA SYSTEMBioanalogics, Inc.·Product code DSB·1997-10-23
K971265 — VIKING DIAGNOSTIC ELECTRODE CATHETERC.R. Bard, Inc.·Product code DRF·1997-10-23
K971980 — MCD-ACAdac Laboratories·Product code KPS·1997-10-23
K972804 — BANG POLYMER GEL DOSIMETER, BANG 533Mgs Research, Inc.·Product code IYE·1997-10-23
K970742 — TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBESBecton Dickinson Immunocytometry Systems·Product code GKZ·1997-10-22
K971015 — AHCS HEMOPERFUSION SYSTEMAmerican Health Care Systems, Inc.·Product code FLD·1997-10-22
K971420 — MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)Richard Wolf Medical Instruments Corp.·Product code HIH·1997-10-22
K971683 — WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNETMarquette Electronics, Inc.·Product code MSX·1997-10-22
K971989 — TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.·Product code LGD·1997-10-22
K972695 — FINALLY FREEMehl/Group Marketing·Product code KCX·1997-10-22
K972760 — LINK, ACETABULAR REVISION MESH CUPLink America, Inc.·Product code JDJ·1997-10-22
K972836 — ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORSG. Premjee (Usa), Inc.·Product code LTZ·1997-10-22
K972880 — MDP2000 MEDICAL DATA PROCESSORVidco, Inc.·Product code MSX·1997-10-22
K973312 — TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSINGInnovative Technologies , Ltd.·Product code MGP·1997-10-22
K973331 — VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)Ortho-Clinical Diagnostics, Inc.·Product code DBF·1997-10-22
K973464 — QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)Instrumentation Laboratory CO·Product code DHR·1997-10-22
K973588 — LIQUID ALKALINE PHOSHATASE REAGENT SETPointe Scientific, Inc.,·Product code CJE·1997-10-22
K963858 — FEMASSIST URINARY DEVICEInsight Medical Corp.·Product code MNG·1997-10-21
K971392 — HISTOFREEZER VERRUCA PLANAOraSure Technologies, Inc.·Product code GEH·1997-10-21
K971436 — NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIESNihon Kohden America, Inc.·Product code LDD·1997-10-21
K971672 — SERAQUEST TOXOPLASMA IGMQuest Intl., Inc.·Product code LGD·1997-10-21
K971897 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)Medron, Inc.·Product code LFK·1997-10-21
K972071 — BOVIE MODEL X40Maxxim Medical·Product code GEI·1997-10-21
K972093 — REGENESIS MODEL 42Regenesis Biomedical, Inc.·Product code ILX·1997-10-21
K972277 — DIGIFLEX SURGICAL GLOVESHms Services, Inc.·Product code KGO·1997-10-21
K972481 — AUTO-LYTE COTININE EIAOraSure Technologies, Inc.·Product code MKU·1997-10-21
K972745 — TITANIUM HEMOSTATIC CLIPEisner USA, Inc.·Product code MCH·1997-10-21
K972746 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100Alexander Mfg. Co.·Product code DPS·1997-10-21
K972752 — DURACON CONVERSION METAL BACKED PATELLAHowmedica Corp.·Product code JWH·1997-10-21
K972765 — NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASERAmerican Laser Medical·Product code GEX·1997-10-21
K972770 — ADVANCE ULTRA-CONGRUENT TIBIAL INSERTWrightmedicaltechnologyinc·Product code JWH·1997-10-21
K972801 — ALLIANCE RUBBER, EC-GRIPAlliance Rubber Products Sdn. Bhd.·Product code LYY·1997-10-21
K972832 — PROVISION SURGICAL HELMET SYSTEMDepuy, Inc.·Product code FYA·1997-10-21
K972837 — NPB-290 PULSE OXIMETER (NPB-290)Nellcor Puritan Bennett, Inc.·Product code DQA·1997-10-21
K972978 — VISTA BRITE TIP GUIDING CATHETERSCordis Corp.·Product code DQY·1997-10-21
K973110 — LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORDLudlow Technical Products·Product code GEI·1997-10-21
K973260 — HYDRASORB STERILE DRESSINGAvitar, Inc.·Product code MGP·1997-10-21
K973283 — ALGINATE/ZINC WOUND DRESSINGInnovative Technologies , Ltd.·Product code KMF·1997-10-21
K973343 — HYDROFLEXGC America, Inc.·Product code ELW·1997-10-21
K973492 — DENTALVIEW PERIOVIEW SYSTEMDentalview, Inc.·Product code EIA·1997-10-21
K973572 — KELOCOTE SCAR GEL AND KELOCOTE LASER GELHanson Medical, Inc.·Product code MDA·1997-10-21
K973811 — POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)Absolute Quality Leadership, Inc.·Product code LYY·1997-10-21
K940583 — VENTANA CD45 PRIMARY ANTIBODYVentana Medical Systems, Inc.·Product code DEH·1997-10-20
K970889 — ULTRASOUND TRANSDUCER DRAPEProtek Medical Products, Inc.·Product code KKX·1997-10-20
K970893 — ULTRASOUND TRANSDUCER DRAPEProtek Medical Products, Inc.·Product code FYA·1997-10-20
K971985 — N-ASSAY TIA PLASMINOGEN TEST KITCrestat Diagnostics, Inc.·Product code GGP·1997-10-20
K972200 — ANEUVYSIONVysis·Product code OYU·1997-10-20
K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KITCrestat Diagnostics, Inc.·Product code DDQ·1997-10-20
K972260 — CS-400 COAGULATION ANALYZER SYSTEM (A1208)Sigma Diagnostics, Inc.·Product code JPA·1997-10-20
K972763 — HEMAPROMPTAerscher Diagnostics·Product code KHE·1997-10-20
K972779 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-PAlexander Mfg. Co.·Product code MRZ·1997-10-20
K972780 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625Alexander Mfg. Co.·Product code MRZ·1997-10-20
K972929 — N ANTISERUM TO HUMAN ALBUMINBehring Diagnostics, Inc.·Product code DCF·1997-10-20
K973006 — QUANTA LITE B2 GPI IGAInova Diagnostics, Inc.·Product code MSV·1997-10-20
K973014 — QUANTA LITE B2GPI IGMInova Diagnostics, Inc.·Product code MSV·1997-10-20
K973022 — ISLAND BIOSURGICAL INC. BNS KIT #1 & #2Island Biosurgical, Inc.·Product code OTN·1997-10-20

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