FDA 510(k) clearances — page 1381

176,637 clearances on record, most recent first.

Clearances — page 1381

138,001–138,100 of 176,637

K880227 — ARTHROBOT(TM) LOWER LIMB POSITIONERAndronic Devices, Ltd.·Product code FQO·1988-02-18
K880265 — WEHBE ARM HOLDEROrthopedic Systems, Inc.·Product code FWZ·1988-02-18
K880266 — MULTI-ENZYME LINEARITY SOLUTIONVerichem Laboratories, Inc.·Product code JJT·1988-02-18
K880282 — LIMA-LTO. SEM MODULAR EXTERNAL STABLIZERLima-Lto, Inc.·Product code JEC·1988-02-18
K880331 — HOOK PUNCH FORCEPS FOR ARTHROSCOPYKibbutz Gilgal Medical C/O Toam U.S.A. Corp.·Product code HRX·1988-02-18
K880405 — SILASTIC NASAL IMPLANT S-TYPEDow Corning Wright·Product code FZE·1988-02-18
K880436 — MICROTRAK HSV CULTURE IDENTIFICATION TESTSyva Co.·Product code GQN·1988-02-18
K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.Plane Iii, Inc.·Product code FTY·1988-02-18
K873331 — ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURGDirected Energy, Inc.·Product code HRX·1988-02-17
K874541 — RRT TOTAL IGE TEST KITIncstar Corp.·Product code DGC·1988-02-17
K874619 — SPECTRON EF ACETABULAR COMPONENTRichards Medical Co., Inc.·Product code JDI·1988-02-17
K874633 — PERMCATH INSERTION TRAYQuinton, Inc.·Product code LFJ·1988-02-17
K874776 — ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIRAdvanced Cardiovascular Systems, Inc.·Product code DQX·1988-02-17
K874802 — FLIPSCREEN QATAlerchek, Inc.·Product code DHB·1988-02-17
K874830 — MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AIDDahlberg Electronics, Inc.·Product code ESD·1988-02-17
K874860 — ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.Acuson Computed Sonography·Product code ITX·1988-02-17
K874893 — MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATORKeithley Instruments, Inc.·Product code IYE·1988-02-17
K875161 — MAT (TM) MICROALBUMIN TESTWampole Laboratories·Product code DCF·1988-02-17
K875201 — PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEGOrthomet, Inc.·Product code JWH·1988-02-17
K875223 — DANNINGER ORTHOPAEDIC AWLDanninger Medical Technology, Inc.·Product code HWJ·1988-02-17
K875254 — GULLSORB IGG INACTIVATION REAGENTGull Laboratories, Inc.·Product code DEW·1988-02-17
K875274 — TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))Incstar Corp.·Product code DHB·1988-02-17
K875282 — QM300 CALIBRATOR B PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code JIX·1988-02-17
K875315 — I.V. START KITSNi-Med, Inc.·Product code LRS·1988-02-17
K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEMUlster Scientific, Inc.·Product code LCP·1988-02-17
K875360 — THE BELTONE 2000 AUDIOMETERBeltone Electronics Corp.·Product code EWO·1988-02-17
K880002 — MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)3M Company·Product code DHB·1988-02-17
K880045 — ACROMED AWL/PUNCH, DEPTH GAUGEBuckman Co., Inc.·Product code HWJ·1988-02-17
K880156 — VOLZ TOTAL WRIST PROSTHESISBiomet, Inc.·Product code KWM·1988-02-17
K880324 — MICRO-AIRE CEMENT REMOVAL TOOLSMicro-Aire Surgical Instruments, Inc.·Product code HSZ·1988-02-17
K880341 — N-IMMUNOGLOBULIN LIGHT CHAIN KITBehring Diagnostics, Inc.·Product code DFH·1988-02-17
K880399 — V-TREND IM DRY-SPOT TESTTexas Immunology, Inc.·Product code KTN·1988-02-17
K874328 — L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REAE.I. Dupont DE Nemours & Co., Inc.·Product code JCF·1988-02-16
K874495 — ADCOMP 4000 HP SYSTEMHealthtek, Inc.·Product code LHI·1988-02-16
K874623 — FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101Cyberfluor, Inc.·Product code CDX·1988-02-16
K874719 — STRATUM ESUAlternative Design Systems, Inc.·Product code JOS·1988-02-16
K874805 — TATUNG'S DENTURE CLEANING SOLUTIONTatung Company of America, Inc.·Product code EFT·1988-02-16
K874836 — ABUSCREEN(R) EIA AMPHETAMINERoche Diagnostic Systems, Inc.·Product code DKZ·1988-02-16
K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)Monoclonal Antibodies, Inc.·Product code GQN·1988-02-16
K875097 — DISPOSABLE SYRINGECalifornia Ent.·Product code FMF·1988-02-16
K875105 — TECHNICON SMAC 3 SYSTEMTechnicon Instruments Corp.·Product code JJC·1988-02-16
K875155 — 60 ML RESERVOIR BAG, ITEM #200Prn Services, Inc.·Product code KPE·1988-02-16
K875186 — IV EXTENSION SETMarquette Medical, Inc.·Product code FPK·1988-02-16
K875349 — STERILE SURGICAL NATURAL LATEX GLOVESMarand Products, Inc.·Product code KGO·1988-02-16
K880046 — HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.·Product code HXY·1988-02-16
K880174 — JMS TRANSFUSION SETJms Co., Ltd.·Product code BRZ·1988-02-16
K880336 — MOBILIMB HAND C.P.M. UNITToronto Medical Corp.·Product code JFA·1988-02-16
K880340 — MODIFIED AIR FLUIDIZED BED, KINAIRKinetic Concepts, Inc.·Product code INX·1988-02-16
K880350 — YUE/FA DISPOSABLE SYRINGEHonway International Co.·Product code FMF·1988-02-16
K880355 — MODEL 938 BATHING SYSTEMFerno Ille-Forge·Product code ILJ·1988-02-16
K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.·Product code GBS·1988-02-16
K880423 — TARGA (WHEELCHAIR)A-Bec Mobility, Inc.·Product code ITI·1988-02-16
K880424 — SCOOTA BUG (MOTORIZED VEHICLE)A-Bec Mobility, Inc.·Product code INI·1988-02-16
K880425 — STERLING (MOTORIZED VEHICLE)A-Bec Mobility, Inc.·Product code INI·1988-02-16
K872660 — BEAR NVM-1Bear Medical Systems, Inc.·Product code BZK·1988-02-12
K872877 — TARGET PROGRAM & EPSON HX-20 COMPUTERWalter Lorenz Surgical, Inc.·Product code HAW·1988-02-12
K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100American Bentley·Product code CCE·1988-02-12
K872920 — AMICI KRYPTON ADMINISTRATION SYSTEM*Amici, Inc.·Product code IYT·1988-02-12
K872971 — PERMANENT MYOCARDIAL LEADS MP SERIESOscor Medical Corp.·Product code DTB·1988-02-12
K873586 — LUNG DIFFUSION GASNational Welders·Product code BXK·1988-02-12
K874412 — THE PROTECTORTri Jon, Inc.·Product code CAE·1988-02-12
K874751 — TRACKER-25 INFUSION CATHETERTarget Therapeutics·Product code DQY·1988-02-12
K874908 — C900 X-RAY FILM PROCESSORSummit Industries, Inc.·Product code IXW·1988-02-12
K874947 — MODEL 8800 CARDIORESPIRATORY OXIMETERNonin Medical, Inc.·Product code DQA·1988-02-12
K875023 — BIOSURGE MODEL OASYS-IIBiosurge, Inc.·Product code CAC·1988-02-12
K875031 — OXYGEN/PULSE MONITORHealthdyne, Inc.·Product code DQA·1988-02-12
K875058 — STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407Busse Hospital Disposables, Inc.·Product code BSY·1988-02-12
K875059 — DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODEDaig Corp.·Product code LDF·1988-02-12
K875269 — ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLEAdvanced Cardiovascular Systems, Inc.·Product code DQY·1988-02-12
K875372 — SHIMADZU CATHETERIZATION C-ARM STAND ER-200Shimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K875373 — C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20Shimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K875374 — SHIMADZU CEILING-SUSPENDED C-ARM CH-50Shimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K875375 — SHIMADZU LATERAL C-ARM MH-30Shimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K875376 — SHIMADZU CATHETERIZATION C-ARM STAND MH-50BShimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K875377 — SHIMADZU MAMMOGRAPHIC STAND MR-30Shimadzu Precision Instruments, Inc.·Product code IZH·1988-02-12
K875379 — SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100AShimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K875380 — SHIMADZU CATHETERIZATION C-ARM STAND MH-10Shimadzu Precision Instruments, Inc.·Product code IZI·1988-02-12
K880247 — MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBESShiley, Inc.·Product code BTO·1988-02-12
K880261 — MOBILE PAK, MODEL ACIntl. Biomedical Concepts, Inc.·Product code CAW·1988-02-12
K880262 — MOBILE PAK, MODEL DCIntl. Biomedical Concepts, Inc.·Product code CAW·1988-02-12
K873039 — MODEL 820 TOP=TRAKSierra Laboratories, Inc.·Product code BYN·1988-02-11
K873409 — WAKO(TM) PRETEST 6AWako Chemicals USA, Inc.·Product code KHE·1988-02-11
K873557 — MENTOR BLACK LIGHT URETERAL STENT SETMentor Corp.·Product code FAD·1988-02-11
K874092 — MASK, OXYGENLife Support Products, Inc.·Product code BYG·1988-02-11
K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETERVan-Tec, Inc.·Product code KOD·1988-02-11
K874189 — DUAL-CURE RADIOPAQUEPentron Corp.·Product code EBF·1988-02-11
K874451 — OMNIPLANE 200 FILM CHANGER SYSTEMMedrad, Inc.·Product code IZP·1988-02-11
K874468 — P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.·Product code LKG·1988-02-11
K874496 — CALCIUM ASSAY KIT, NUMBER 120-19Diagnostic Chemicals, Ltd. (Usa)·Product code CIC·1988-02-11
K874498 — CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.·Product code LKG·1988-02-11
K874564 — MINIMED III INFUSION PUMP & UNI-SET ADMIN SETMedtronic Minimed·Product code FRN·1988-02-11
K874716 — PULSOR, THERAPEUTIC VIBRATORGmg Enterprises, Inc.·Product code ISA·1988-02-11
K874782 — COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KITDiagnostic Products Corp.·Product code JLX·1988-02-11
K874804 — OXYGEN SUPPLY CONTROL REGULATOR (OSCR)Transamerica Products, Inc.·Product code NFB·1988-02-11
K874814 — HEALTHDYNE RATE METERHealthdyne, Inc.·Product code BZQ·1988-02-11
K874832 — NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROLNova Biomedical Corp.·Product code JGS·1988-02-11
K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASESerono Diagnostics, Inc.·Product code KLI·1988-02-11
K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)Simmler, Inc.·Product code JPZ·1988-02-11
K874918 — IRON PROCEDUREData Medical Associates, Inc.·Product code JIY·1988-02-11
K875037 — STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BEDStryker Corp.·Product code FNL·1988-02-11

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