FDA 510(k) clearances — page 1427

176,637 clearances on record, most recent first.

Clearances — page 1427

142,601–142,700 of 176,637

K864850 — WAKO(TM) AUTOKIT GPTWako Chemicals USA, Inc.·Product code CKA·1987-01-09
K864865 — SPECULUM, VAGINAL, METAL FIBEROPTICLuxtec Corp.·Product code HDG·1987-01-09
K864894 — EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93Em Diagnostic Systems, Inc.·Product code DMT·1987-01-09
K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONEDiagnostics Biochem Canada, Inc.·Product code CGF·1987-01-09
K864974 — GENERAL PURPOSE CENTRIFUGENorfolk Scientific, Inc.·Product code JQC·1987-01-09
K865014 — LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & IIBio-Rad·Product code DGR·1987-01-09
K864553 — EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95Em Diagnostic Systems, Inc.·Product code KLT·1987-01-08
K864607 — EASY-TEST QUINIDINE ITEM NO. 67---/95Em Diagnostic Systems, Inc.·Product code LBZ·1987-01-08
K864675 — MODEL FORCE 4B ELECTROSURGICAL GENERATORValleylab, Inc.·Product code GEI·1987-01-08
K864785 — AMOENA BREAST FORMSColoplast Corp.·Product code GBI·1987-01-08
K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHTColoplast Corp.·Product code GBI·1987-01-08
K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGECurrie Medical Specialties, Inc.·1987-01-08
K864851 — MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATORValleylab, Inc.·Product code GEI·1987-01-08
K861514 — VNA OPTICAL CORRELATORVna Systems, Inc.·Product code LLZ·1987-01-07
K862286 — ARTHROPHONOMETERArthrotek, Inc.·Product code NFQ·1987-01-07
K862315 — FYODOROV COLLAGEN CORNEAL SHIELDMedical Technology Development Corp.·Product code MOE·1987-01-07
K862916 — EZ-SCREEN: CANNABINOIDEnvironmental Diagnostics, Inc.·Product code KLT·1987-01-07
K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOROb/Gyn Concepts, Ltd.·Product code KOH·1987-01-07
K863918 — MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.Marquest Medical Products, Inc.·Product code DQA·1987-01-07
K864321 — MICRO-VENTCore-Vent Corp.·Product code DZE·1987-01-07
K864346 — REMBRANDT PORCELAIN TINTING KITDen-Mat Corp.·Product code EBF·1987-01-07
K864527 — DUOCEPHGary E. Hall, Dds·Product code IWY·1987-01-07
K864554 — EASY-TEST PRIMIDONE ITEM NO. 67---/95Em Diagnostic Systems, Inc.·Product code DIP·1987-01-07
K864677 — TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEPSerono Diagnostics, Inc.·Product code JLW·1987-01-07
K864925 — EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95Em Diagnostic Systems, Inc.·Product code DIP·1987-01-07
K864926 — EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95Em Diagnostic Systems, Inc.·Product code DLZ·1987-01-07
K861188 — SPERM CAPACITATION MEDIUMIrvine Scientific·Product code HDR·1987-01-06
K861241 — ANGIOTOPO CATHETERHouston Biomedical, Inc.·Product code DQO·1987-01-06
K862051 — MODEL 436-01 BIOPORE IMPLANTABLE PACING LEADIntermedics, Inc.·Product code DTB·1987-01-06
K862055 — CANWEST OVU-BLUECanwest Medictex, Inc.·Product code CEP·1987-01-06
K863153 — MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPHOcg Technology, Inc.·Product code DXG·1987-01-06
K863369 — MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODESTdk Corp.·Product code DRX·1987-01-06
K863535 — LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.Computerized Medical Systems, Inc.·Product code DPS·1987-01-06
K863536 — MEDTRONIC MODEL 5013Medtronic Vascular·Product code DTB·1987-01-06
K863684 — URESIL SUBCLAVIAN CATHETERUresil Corp.·Product code DQY·1987-01-06
K863705 — COMPUTER CONTROLLED EXTENSION (CCX)Varian Assoc., Inc.·Product code IYE·1987-01-06
K863855 — ACCUSATDatascope Corp.·Product code DQA·1987-01-06
K863904 — DISPOSABLE ECG MONITORING ELECTRODEClinical Data, Inc.·Product code DRX·1987-01-06
K863914 — MODIFICATION TO DYNASCOPE SERIES MONITORSFukuda Denshi USA, Inc.·Product code DPS·1987-01-06
K863916 — CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEMCardio-Vascular Innovations, Inc.·Product code DQY·1987-01-06
K863917 — CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.Cardio-Vascular Innovations, Inc.·Product code DYB·1987-01-06
K863936 — DUFFY BOLUS INJECTORViox Corp.·Product code IWR·1987-01-06
K864062 — PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)Ideas For Medicine, Inc.·Product code DXE·1987-01-06
K864153 — PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290Pace Medical·Product code DTB·1987-01-06
K864330 — SHEAR FORCE GAUGEAmerican Edwards Laboratories·Product code DXE·1987-01-06
K864331 — TRI-LOCK LONG STEM MODULAR NECKDepuy, Inc.·1987-01-06
K864352 — MODIFIED PEEL-AWAY INTRODUCER SET LINEQuinton, Inc.·Product code DYB·1987-01-06
K864468 — TRACHEOBRONCHIAL SUCTION CATHETERSheridan Catheter Corp.·Product code BSY·1987-01-06
K864503 — MODIFIED RLV-2100 BAmerican Omni Medical, Inc.·Product code DWD·1987-01-06
K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110Concord Laboratories, Inc.·Product code BSY·1987-01-06
K864601 — CCS POLYSAFE(TM) ENDOCARDIAL PACING LEADCardiac Control Systems, Inc.·Product code DTB·1987-01-06
K864637 — MODIFIED ESCHMANN DILATATION CATHETEREschmann Bros. & Walsh , Ltd.·1987-01-06
K864640 — ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEADCordis Corp.·Product code DTB·1987-01-06
K864682 — SALT CREEK P.I. TRAYSalt Creek Medical Technologies·1987-01-06
K864738 — MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAPIntermedics, Inc.·Product code DTB·1987-01-06
K864823 — BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1Bernafon, Inc.·Product code ESD·1987-01-06
K864856 — MODEL 5866-24 PACEMAKER LEAD ADAPTORMedtronic Vascular·Product code DTB·1987-01-06
K864878 — ICU/CPU TRANSPORT TRAYOrthopedic Systems, Inc.·Product code FNJ·1987-01-06
K853952 — METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWMEMetriflow, Inc.·Product code DPW·1987-01-05
K861205 — 1990A BIO-RESISTANCE BODY COMPOSITION ANALYZERValhalla Scientific·Product code DSB·1987-01-05
K862867 — EUB-310 ULTRASONIC SCANNERHitachi Medical Corp. of America·Product code IYO·1987-01-05
K863470 — DALTEX IV INFUSION PUMPDaltex Medical Sciences, Inc.·Product code FRN·1987-01-05
K864211 — IL TEST 97575-15, HEPARIN ASSAYInstrumentation Laboratory CO·Product code KFF·1987-01-05
K864224 — ABBOTT SPECTRUM GLUCOSE REAGENTAbbott Laboratories·Product code CGA·1987-01-05
K864333 — DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAYWindsor Laboratories, Inc.·Product code KXT·1987-01-05
K864392 — PROTIME AUTOMATE TEST KITAmerican Bioproducts Co.·Product code GJS·1987-01-05
K864481 — COAGULATION INTRINSIC DEFICIENT PLASMASInstrumentation Laboratory CO·Product code GGP·1987-01-05
K864497 — COAGULATION EXTRINSIC DEFICIENT PLASMASInstrumentation Laboratory CO·Product code GGP·1987-01-05
K864646 — SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGEE.I. Dupont DE Nemours & Co., Inc.·Product code GKF·1987-01-05
K864669 — AM CATH ESWL STENTInter-Med Corp.·Product code FAD·1987-01-05
K864674 — MICRODILUTION IDENTIFICATION PANELSAmerican Micro Scan·Product code JSE·1987-01-05
K864706 — RAICHEM(TM) AMMONIA REAGENTReagents Applications, Inc.·Product code JIF·1987-01-05
K864727 — CULT-URR.P. Laboratories, Inc.·Product code LIO·1987-01-05
K864733 — LKB 2260 MACROTOMELkb Instruments, Inc.·Product code IDO·1987-01-05
K864740 — BONE MARROW COLLECTION MEDIUMBioclinical Laboratory Services, Inc.·Product code KIT·1987-01-05
K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORMGibco Laboratories Life Technologies, Inc.·Product code JSJ·1987-01-05
K864817 — S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELSS & W Enterprises, Inc.·Product code INQ·1987-01-05
K864907 — SUNTANNING LAMPInterlectric Corp.·Product code FTC·1987-01-05
K864945 — TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYHybritech, Inc.·Product code JFH·1987-01-05
K862211 — ULTRASOUND TRANSDUCER ASSEMBLYJohnson & Johnson Professionals, Inc.·Product code ITX·1987-01-02
K862459 — MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSEMedtronic Vascular·Product code DXY·1987-01-02
K862724 — VEIN VALVE CUTTERAmerican Edwards Laboratories·Product code DQY·1987-01-02
K863308 — 2200I PHYSIOLOGICAL MONITORDatascope Corp.·Product code DXG·1987-01-02
K864007 — EMBOLECTOMY/THROMBECTOMY BALLOON CATHETERUresil Corp.·Product code DXE·1987-01-02
K864235 — BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600C.R. Bard, Inc.·Product code DTZ·1987-01-02
K864262 — ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATINGJohnson & Johnson Professionals, Inc.·Product code DTM·1987-01-02
K863069 — MAGNESIOMETERJ. D. Assoc.·Product code JGJ·1986-12-31
K863580 — DERMATEC TRANSPARENT FILM DRESSINGDermatec, Inc.·Product code NAD·1986-12-31
K864236 — SYNCHRON CX3Beckman Instruments, Inc.·Product code JJF·1986-12-31
K864303 — QKO (TM) AMYLASE B-HAWako Chemicals USA, Inc.·Product code JFJ·1986-12-31
K864634 — AP1 COLORIMETERAwareness Technology, Inc.·Product code JJQ·1986-12-31
K864713 — CHLORIDE REAGENTSigma Diagnostics, Inc.·Product code CHJ·1986-12-31
K864715 — EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93Em Diagnostic Systems, Inc.·Product code CIX·1986-12-31
K864776 — A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSBartels Immunodiagnostic Supplies, Inc.·Product code KIR·1986-12-31
K864906 — ALANINE AMINO TRANSFERASE ALT/SGPTTech-Co, Inc.·Product code CKA·1986-12-31
K864939 — BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KITBeckman Instruments, Inc.·Product code CDT·1986-12-31
K864495 — MEDSURG VASCULAR ACCESS PORT INFUSION TRAYMedsurg Industries, Inc.·1986-12-30
K864570 — PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIMEDongkuk Techco Rubber Industries·Product code HIS·1986-12-30
K864892 — ELLISON ARTHROSCOPY CHEATERBuckman Co., Inc.·Product code HRX·1986-12-30
K863237 — HYDROXYLAPATITE BONE GRAFT MATERIALRichards Medical Co., Inc.·Product code LYC·1986-12-29

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