FDA 510(k) clearances — page 1256

176,637 clearances on record, most recent first.

Clearances — page 1256

125,501–125,600 of 176,637

K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.·Product code JIW·1990-10-04
K902972 — FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)Cmp Industries, LLC·Product code EBI·1990-10-04
K903079 — ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)Luxar Corp.·Product code GEX·1990-10-04
K903233 — SYNERMED CALCIUM REAGENT KITSynermed, Inc.·Product code CIC·1990-10-04
K903340 — STERILE URETHRAL CATHETER PROCEDURE KITSSuperior Healthcare Group, Inc.·Product code FCM·1990-10-04
K903409 — SYSTEMATE BICARBONATE OLYMPUS BICARBONATEEm Diagnostic Systems, Inc.·Product code KHS·1990-10-04
K903654 — LISS CRANIAL STIMULATOR MODEL SBL202-BMedical Consultants Intl. , Ltd.·Product code QJQ·1990-10-04
K903665 — CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGYUnipath , Ltd.·Product code GKZ·1990-10-04
K903775 — CREATINE PHOSPHOKINASEAmresco, Inc.·Product code CGS·1990-10-04
K903911 — GEN-PROBE PAL LUMINOMETERGen-Probe, Inc.·Product code JJQ·1990-10-04
K903933 — DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2Baxter Healthcare Corp·Product code JJY·1990-10-04
K904015 — ELECTRO-BLEND EPILATOR, MODEL UC-3A.R. Hinkel Co., Inc.·Product code KCW·1990-10-04
K904122 — INSYTE-A ARTERIAL CATHETERIZATION UNITDeseret Medical, Inc.·Product code FOZ·1990-10-04
K904337 — OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.Medical Fittings, Inc.·Product code BYX·1990-10-04
K900051 — MOORE TYPE ENDO PROSTHESISLima Intl. Corp.·Product code KWY·1990-10-03
K900858 — CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LESCandela Laser Corp.·Product code GEX·1990-10-03
K901901 — PROFILE, A CRITICAL CARE LOW AIR LOSS BEDKinetic Concepts, Inc.·Product code FNM·1990-10-03
K902939 — OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEMTrimedyne, Inc.·Product code GEX·1990-10-03
K902940 — CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEMTrimedyne, Inc.·Product code GEX·1990-10-03
K902943 — RSI FEMORAL GUIDING CATHETERRetroperfusion Systems, Inc.·Product code DQO·1990-10-03
K902961 — DIMENSION-II TOTAL HIP SYSTEMKirschner Medical Corp.·Product code JDI·1990-10-03
K902991 — ICON STREP B IMMUNOENZYMETRIC ASSAYHybritech, Inc.·Product code GTY·1990-10-03
K903084 — MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.·Product code LZY·1990-10-03
K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEAmici, Inc.·Product code IYT·1990-10-03
K903732 — KENDALL SAFETRAK(TM) HIGH FLOW CATHETERKendall Healthcare Products Co. Div.Of Tyco Health·Product code FOZ·1990-10-03
K903809 — PROTECTED NEEDLE WITH OR WITHOUT IV SETKendall Mcgaw Laboratories, Inc.·Product code FPA·1990-10-03
K903879 — IVAC(R) SYRINGE PUMP - MODEL 740Y·Product code FRN·1990-10-03
K903914 — PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANKBaxter Healthcare Corp·Product code JGQ·1990-10-03
K903942 — SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150GShimadzu Medical Systems·Product code IZO·1990-10-03
K904011 — MODEL #527 OPHTHALMIC STRETCHERMidmark Corp.·Product code FPO·1990-10-03
K904054 — POLYVIOLENE(TM) SUTURELook, Inc.·Product code GAS·1990-10-03
K904123 — CIBA CORNING ACS HCG IMMUNOASSAYCiba Corning Diagnostics Corp.·Product code JHI·1990-10-03
K904217 — PRO-LOK (TM) EXTENSION SETSVlv Associates, Inc.·Product code FPA·1990-10-03
K904238 — KODAK X-MAT 270 RA PROCESSOREastman Kodak Company·Product code IXW·1990-10-03
K904283 — PS MEDICAL CRANIAL HAND DRILLPudenz-Schulte Medical Research Corp.·Product code HBG·1990-10-03
K904324 — LATEX EXAMINATION GLOVEGallimore Ent., Inc.·Product code LYY·1990-10-03
K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKEDelmed, Inc.·Product code KNT·1990-10-02
K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERADelmed, Inc.·Product code KNT·1990-10-02
K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKEDelmed, Inc.·Product code KNT·1990-10-02
K896017 — THE OPHTHIMUS SYSTEMHightech Vision·Product code DQK·1990-10-02
K902133 — MODEL IS102S ND:YAG SURGICAL LASER SYSTEMNiic U.S.A., Inc.·Product code GEX·1990-10-02
K902595 — CATARRHALIS TEST STRIPRemel Co.·Product code JTO·1990-10-02
K902604 — BLAKE MEDICAL BREATHING TUBE SUPPORTBlake Medical, Inc.·Product code CBH·1990-10-02
K902946 — PEGASUS W/ACCESSORIES FOR GENERAL SURGERYPfizer Laser Systems·Product code GEX·1990-10-02
K902947 — PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATIONPfizer Laser Systems·Product code GEX·1990-10-02
K902990 — COHERENT HOLMIUM:YAG SURGICAL LASERCoherent Medical Division·Product code GEX·1990-10-02
K903027 — PEGASUS WITH ACCESSORIESPfizer Laser Systems·Product code GEX·1990-10-02
K903302 — ELECTRODE, ELECTROSURGERYMegadyne Medical Products, Inc.·Product code JOS·1990-10-02
K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBEShiley, Inc.·Product code JOH·1990-10-02
K903556 — ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TESTGen-Probe, Inc.·Product code MDE·1990-10-02
K903765 — QUIDEL CHLAMYDIA POSITIVE CONTROLQuidel Corp.·Product code LJC·1990-10-02
K903843 — IMMUNODOT THYROID AUTOIMMUNITY PANELGeneral Biometrics, Inc.·Product code JNL·1990-10-02
K904047 — ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.Gen-Probe, Inc.·Product code MDF·1990-10-02
K904086 — DISCRENE SELF-SUPPORTING BREAST FORMColoplast A/S·Product code KCZ·1990-10-02
K904136 — SUTURE TENSION ADJUSTMENT REELSurgical Systems, Inc.·Product code KGS·1990-10-02
K904346 — BAUMAN CPR/RESUSCITATORGeneral Medical Products, Inc.·Product code BTM·1990-10-02
K893582 — N-A-G TEST KITPpr Diagnostics , Ltd.·Product code CGX·1990-10-01
K901290 — ELECTRO-GONIOMETER DIAGNOSTIC DEVICEChattanooga Group, Inc.·Product code LBB·1990-10-01
K902084 — OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATEOhmeda Medical·Product code CBK·1990-10-01
K902320 — BAUER FLEXI-TEMNO BIOPSY NEEDLEProact, Ltd.·Product code FCG·1990-10-01
K902641 — RPI ENTERAL FEEDING BAG 1000ML AND 500MLRidge Products, Inc.·Product code KNT·1990-10-01
K902808 — DRIPTROLTrans-Pacific Healthcare-USA·Product code FLN·1990-10-01
K903015 — SYNERMED CHOLESTEROL REAGENT KITSynermed, Inc.·Product code CHH·1990-10-01
K903096 — RACK-IT (R)Vengo Industries, Inc.·Product code FLE·1990-10-01
K903323 — RESECTOSCOPE LOOPSOlympus Corp.·Product code KNS·1990-10-01
K903375 — HICORSiemens Gammasonics, Inc.·Product code IZI·1990-10-01
K903403 — CT-COMPATIBLE FLETCHER SYSTEM APPLICATORUniversity of Michigan·Product code IWJ·1990-10-01
K903446 — COMFIT SURGEON'S GLOVESWembley Rubber Products (M) Sdn Bhd·Product code KGO·1990-10-01
K903456 — PREMIER-C. DIFFICILE TOXIN AMeridian Diagnostics, Inc.·Product code LLH·1990-10-01
K903822 — MODEL 4500-SMS-42; SHOULDER COILMedical Advances, Inc.·Product code LNH·1990-10-01
K903897 — TRIGLYCERIDES REAGENT GPO 5 X CONC.Trace Scientific , Ltd.·Product code CDT·1990-10-01
K904013 — SPIVE NEEDLE SYSTEM, MODIFICATIONPascall Medical Corp.·Product code FPA·1990-10-01
K904048 — MULTI DRUG INFUSION SYSTEMI-Flow Corp.·Product code FRN·1990-10-01
K904286 — SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIEDScale-Tronix, Inc.·Product code FRW·1990-10-01
K904312 — RHEUMAGEN CRP T-CONTROLBiokit USA, Inc.·Product code DCK·1990-10-01
K896758 — GAMBRO BICARBONATE MONITOR BCM 10-3Gambro, Inc.·Product code FKP·1990-09-28
K897086 — PARKER AMBULATORY MEDICATION INFUSION PUMP 2004Parker Hannifin Corp.·Product code FRN·1990-09-28
K901162 — STERIMATIC(TM) SAFETY NEEDLESterimatic Worldwide, Ltd.·Product code FMI·1990-09-28
K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTSMumtaz I. Malik·Product code LXH·1990-09-28
K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8Mumtaz I. Malik·Product code LXH·1990-09-28
K901511 — CHISEL, BONE, SURGICALMumtaz I. Malik·Product code LXH·1990-09-28
K901521 — OSTEOTOMES OF VARIOUS TYPESMumtaz I. Malik·Product code LXH·1990-09-28
K901978 — MULTI-DRUG INFUSION SYSTEMI-Flow Corp.·Product code FRN·1990-09-28
K902032 — O. B. PACK IVCustomed, Inc.·Product code HFC·1990-09-28
K902715 — SURGICAL TOWELAztec Medical, Inc.·Product code KKX·1990-09-28
K902953 — SOFTOUCH GUIDING CATHETERMallinckrodt Medical·Product code DQO·1990-09-28
K903724 — BEAMER 1,2,4,6, AND 8Beacon Laboratories, Inc.·Product code GEI·1990-09-28
K901885 — PARTNER VOLUME MONITORBird Products Corp.·Product code BZK·1990-09-27
K901899 — ROADRUNNER WIRE GUIDECook, Inc.·Product code DQX·1990-09-27
K902394 — RESUBMITTED MULTIORGAN PERFUSION CANNULAFresenius USA, Inc.·Product code DWF·1990-09-27
K902429 — MODIFIED HEARTSTART DEFIBRILLATION ELECTRODELaerdal Mfg. Corp.·Product code LDD·1990-09-27
K902583 — JOINT MOTON IMAGER(TM)Concord Imaging, Ltd.·Product code JAA·1990-09-27
K902606 — RADIOPAQUE RULERProfessional Medical Services·Product code KPR·1990-09-27
K902779 — MODIFICATION TYPE 9266 SA02 SYSTEM ATHENAS & W Medico Teknik·Product code DQA·1990-09-27
K902856 — BARD FILTERED CARDIOTOMY RESERVOIRC.R. Bard, Inc.·Product code DTP·1990-09-27
K902860 — INTELECT 170Chattanooga Group, Inc.·Product code IMG·1990-09-27
K902872 — NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*United States Surgical, A Division of Tyco Healthc·Product code GAW·1990-09-27
K902873 — NONABSORBABLE DACRON SURGICAL SUTURE*United States Surgical, A Division of Tyco Healthc·Product code GAS·1990-09-27
K902875 — INTELECT 750 MPChattanooga Group, Inc.·Product code IMG·1990-09-27
K902935 — ROCHE COBAS READY HDL CHOLESTEROL REAGENTRoche Diagnostic Systems, Inc.·Product code JHM·1990-09-27

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