FDA 510(k) clearances — page 1215

176,637 clearances on record, most recent first.

Clearances — page 1215

121,401–121,500 of 176,637

K911764 — IMAC2000Medical Imaging Technologies, Inc.·Product code JAK·1991-09-23
K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAYNorth American Sterilization & Packaging Co.·Product code BTQ·1991-09-23
K912020 — ANTI-DNA MICROASSAYDiamedix Corp.·Product code LRM·1991-09-23
K912122 — CHOLANGIOGRAPHY CATHETERWiltek Medical, Inc.·Product code FGE·1991-09-23
K912224 — LIFECARE CPAP-100Lifecare Services, Inc.·Product code BZD·1991-09-23
K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETERWiltek Medical, Inc.·Product code FGE·1991-09-23
K912347 — BIPURE 1000Laser Engineering, Inc.·Product code FYD·1991-09-23
K912371 — BIOMERIEUX RSV DIRECT IF KITVitek Systems, Inc.·Product code LKT·1991-09-23
K912392 — PROBE LATEX EXAMINATION GLOVES - STERILEGlovetex Industries·Product code LYY·1991-09-23
K912420 — ORTHOFIX UNREAMED TIBIAL NAIL SYSTEMScientific Research·Product code HSB·1991-09-23
K912478 — SEVACARE STERILE SURGEON'S GLOVESSevaids Industries·Product code KGO·1991-09-23
K912749 — REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN BMedical Analysis Systems, Inc.·Product code MSJ·1991-09-23
K912753 — XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROLXomed-Treace, Inc.·Product code GCX·1991-09-23
K912798 — AMPLANTZ AND BENTSON GUIDEWIRESMeadox Medicals, Div. Boston Scientific Corp.·Product code DQX·1991-09-23
K912833 — CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAYCamino Laboratories, Inc.·Product code DSK·1991-09-23
K912877 — PROFUSE INFUSION SYSTEMLake Region Mfg., Inc.·Product code DQY·1991-09-23
K912911 — LOW POROSITY (LP) VASCULAR PROSTHESISIntervascular, Inc.·Product code DSY·1991-09-23
K912947 — STARPAC O.R. TOWELMulti M Intl., Inc.·Product code KKX·1991-09-23
K912972 — FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBEAbbott Laboratories·Product code FPD·1991-09-23
K913002 — BACTIDROP(TM) FERRIC CHLORIDE (10%)Remel Co.·Product code JTO·1991-09-23
K913003 — BACTIDROP(TM) VOGES-PROSKAUER ARemel Co.·Product code JTO·1991-09-23
K913006 — BACTIDROP(TM) DOBELL & O'CONNOR IODINERemel Co.·Product code JTO·1991-09-23
K913007 — BACTIDROP(TM) VOGES-PROSKAUER BRemel Co.·Product code JTO·1991-09-23
K913008 — BACTIDROP(TM) OXIDASERemel Co.·Product code JTO·1991-09-23
K913012 — DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXESEigen·Product code JAA·1991-09-23
K913128 — HEMATASTAT C-70BSeparation Technology, Inc.·Product code GKG·1991-09-23
K913142 — BODEN WHEELCHAIR DRAINAGE SYSTEMMno Medical Products·Product code KNX·1991-09-23
K913158 — MODIFIED OSCOR PY PACING LEADS/MODIFICATIONOscor Medical Corp.·Product code DTB·1991-09-23
K913187 — INNOFLUOR(TM) DIGITOXIN REAGENT SETIntl. Bioclinical, Inc.·Product code LFM·1991-09-23
K913201 — PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATIONOscor Medical Corp.·Product code DTB·1991-09-23
K913202 — IMPLANT PACING LEAD, TINED #3262, MODIFICATIONOscor Medical Corp.·Product code DTB·1991-09-23
K913203 — IMPLANT PACING LEAD TINED #3390, MODIFICATIONOscor Medical Corp.·Product code DTB·1991-09-23
K913204 — MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATIONOscor Medical Corp.·Product code DTB·1991-09-23
K913205 — OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIFOscor Medical Corp.·Product code DTB·1991-09-23
K913215 — SURGIFIT STERILE SURGICAL GLOVESHevealactics Intl. Sdn Bhd·Product code KGO·1991-09-23
K913234 — VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLYVarian Canada, Inc.·Product code IZO·1991-09-23
K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PADProcter & Gamble Co.·Product code HHL·1991-09-23
K913238 — ALWAYS, UNSCENTED MENSTRUAL PADProcter & Gamble Co.·Product code HHL·1991-09-23
K913279 — LATEX EXAMINATION GLOVESLiwe Trading·Product code LYY·1991-09-23
K913323 — ETUDE (MODEL NUMBERS 24A05 & 24A06)Dantec Medical, Inc.·Product code FAP·1991-09-23
K913393 — IMPLANT PACING LEAD, RETRACTABLE, MODIFICATIONOscor Medical Corp.·Product code DTB·1991-09-23
K913510 — MECHANICAL SHAPE SENSORPin Dot Products, Inc.·Product code JFC·1991-09-23
K913627 — 3 PORT ADAPTERBaxter Healthcare Corp·Product code FPA·1991-09-23
K913828 — QTEST INFLUENZA ABd Becton Dickinson Vacutainer Systems Preanalytic·Product code GNT·1991-09-23
K914017 — UC312, ULTRA MINIATURE ITC HEARING AIDQualitone·Product code ESD·1991-09-23
K904176 — GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDERGalix Instrumentacion Biomedica·Product code DSH·1991-09-20
K904177 — GALIX MA-6C HOLTER CASSETTE RECORDERGalix Instrumentacion Biomedica·Product code DSH·1991-09-20
K912777 — CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETERCordis Corp.·Product code DQY·1991-09-20
K912789 — LM-100/200LOW FLOW INSUFFLATORLeisegang Medical, Inc.·Product code HIG·1991-09-20
K910004 — FURUI SHUNT, 2-WAY AND 3-WAYTheramed, Inc.·Product code DWF·1991-09-19
K910647 — XIMATRON/CT OPTIONFischer Imaging Corp.·Product code KPQ·1991-09-19
K910786 — TROCAR (FALLER STYLET)Accurate Surgical Instruments Co.·Product code FJS·1991-09-19
K911127 — COLLIMASTER-90Varian Assoc., Inc.·Product code IZW·1991-09-19
K911312 — SUCTION/IRRIGATION TUBE & TUBE WITH CHANNELNorthgate Technologies, Inc.·Product code GEI·1991-09-19
K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)Aequitron Medical, Inc.·Product code DZD·1991-09-19
K911647 — NGM GAS MODULEDatex Division Instrumentarium Corp.·Product code CBQ·1991-09-19
K912005 — CODMAN SKULL PINS (ADULT & CHILD), REUSABLECodman & Shurtleff, Inc.·Product code HBL·1991-09-19
K912087 — ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUSInstrumentation Laboratory CO·Product code JPA·1991-09-19
K912097 — AUTO SUTURE ENDOSCOPIC FASCIA STAPLERUnited States Surgical, A Division of Tyco Healthc·Product code GCJ·1991-09-19
K912515 — FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110Continental X-Ray Corp.·Product code KPR·1991-09-19
K912517 — FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109Continental X-Ray Corp.·Product code KPR·1991-09-19
K912790 — SURGICAL GOWNUnicor Federal Dept. of Justice·Product code FYE·1991-09-19
K912927 — AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVEIntl. Medical, Inc.·Product code GCJ·1991-09-19
K912974 — MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEMElscint, Inc.·Product code IZH·1991-09-19
K913010 — BACTIDROP (TM) NITRATE BRemel Co.·Product code JTO·1991-09-19
K913011 — BACTIDROP(TM) NITRATE ARemel Co.·Product code JTO·1991-09-19
K913048 — SIME TRUFEELSime Health, Ltd.·Product code LYY·1991-09-19
K913123 — EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORSSyva Co.·Product code KLS·1991-09-19
K913147 — SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100Shimadzu Medical Systems·Product code IXR·1991-09-19
K913243 — BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLEBennett X-Ray Corp.·Product code IXG·1991-09-19
K913534 — VISTA HPQ SYSTEMPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1991-09-19
K913687 — CHEM-CHEXStreck Laboratories, Inc.·Product code JJY·1991-09-19
K913846 — ABBOTT QUICKSTART ALANINE AMINOTRANSFEREm Diagnostic Systems, Inc.·Product code CKA·1991-09-19
K913863 — URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)Immunalysis Corporation·Product code DJG·1991-09-19
K913867 — URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis Corporation·Product code KLN·1991-09-19
K913922 — ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01Em Diagnostic Systems, Inc.·Product code JMO·1991-09-19
K905059 — HIGH SPEED MAGNETIC STIMULATORCadwell Laboratories, Inc.·Product code GWF·1991-09-18
K905263 — UTAH ESSUUtah Medical Products, Inc.·Product code HGI·1991-09-18
K911747 — PRO-GUIDEAmerican Interventional Technology·Product code DQY·1991-09-18
K911912 — SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)Serono-Baker Diagnostics, Inc.·Product code KHQ·1991-09-18
K912235 — MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEADIntermedics, Inc.·Product code DTB·1991-09-18
K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICESVascutech, Inc.·Product code DWP·1991-09-18
K912614 — ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTSAndrew Surgical·Product code GEI·1991-09-18
K912702 — PLASTIC ATTACHABLE DUAL PORTDavol, Inc.·Product code LJT·1991-09-18
K912793 — SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS)Surgical Laser Technologies, Inc.·Product code GEX·1991-09-18
K913001 — BACTIDROP(TM) DESOXYCHOLATE (10%)Remel Co.·Product code JTO·1991-09-18
K913004 — BACTIDROP(TM) SPOT INDOLERemel Co.·Product code JTO·1991-09-18
K913009 — BACTIDROP(TM) INDOLE (KOVACS)Remel Co.·Product code JTO·1991-09-18
K913135 — LM-300TWINLeisegang Medical, Inc.·Product code FSW·1991-09-18
K913347 — PALMER ARCH SUPPRESSORSmith & Nephew Dyonics, Inc.·Product code HRX·1991-09-18
K913592 — QUALITONE 46PP-AGC-IQualitone·Product code ESD·1991-09-18
K913707 — ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28Em Diagnostic Systems, Inc.·Product code CGX·1991-09-18
K913771 — ELEGANCE - KED, BEHIND THE EAR HEARING AIDQualitone·Product code ESD·1991-09-18
K913781 — QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AIDQualitone·Product code ESD·1991-09-18
K913865 — URINE THC DIRECT RIA KIT (I-125)Immunalysis Corporation·Product code LAT·1991-09-18
K904622 — HEARING CHECKER(TM), DESKTOP MODELQualitone Hearing Aids and Audiometers·Product code EWO·1991-09-17
K904871 — MEDI-KLEERNorth American Marketing Corp.·Product code OCT·1991-09-17
K905747 — LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSORCoopervision Surgical·Product code HGI·1991-09-17
K910965 — ECHOMARK CSI INTERFACECatheter Sciences Co.·Product code LIT·1991-09-17
K912202 — RICH-MAR MODEL 25 ULTRASOUNDRich-Mar Corp.·Product code IMI·1991-09-17

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