FDA 510(k) clearances — page 1395

176,637 clearances on record, most recent first.

Clearances — page 1395

139,401–139,500 of 176,637

K873559 — U-IMPULSE TVC AIR CONDUCTION HEARING AIDRichards Medical Co., Inc.·Product code ESD·1987-10-14
K873948 — MODIFIED RECTAL NOZZLEColon Therapeutics·Product code KPL·1987-10-14
K871526 — ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDERCox Family Laboratories, Inc.·Product code EXB·1987-10-13
K871931 — ISTAT SOFTWARENeuroscience, Inc.·Product code GWS·1987-10-13
K872124 — CHURCHILL ALBUMIN IV ADMINISTRATION SETChurchill Corp.·Product code FPA·1987-10-13
K872221 — DIALY-NATE SET & DIALY-NATE CATHETERGesco Intl., Inc.·Product code FKO·1987-10-13
K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309Travenol Laboratories, S.A.·Product code FII·1987-10-13
K872534 — 4LYF OXYGEN CONCENTRATORAirsep Corp.·Product code CAW·1987-10-13
K872876 — IMSI/EASY FLOAT MATTRESSIntl. Management Services, Inc.·Product code FOH·1987-10-13
K873732 — TRACH CARE START KITBallard Medical Products·Product code BSY·1987-10-13
K873773 — ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASERHgm, Inc.·Product code GEX·1987-10-13
K873793 — INSPIREASE(R), DRUG DELIVERY SYSTEMKey Pharmaceuticals, Inc.·Product code CCQ·1987-10-13
K873861 — ALBUMIN IN URINEUnipath , Ltd.·Product code DCF·1987-10-13
K873863 — APOLIPOPROTEIN A1Unipath , Ltd.·Product code MSJ·1987-10-13
K873864 — APOLIPOPROTEIN BUnipath , Ltd.·Product code MSJ·1987-10-13
K873865 — CRPUnipath , Ltd.·Product code DCK·1987-10-13
K873867 — TRANSFERRINUnipath , Ltd.·Product code DDG·1987-10-13
K873869 — IMMUNOGLOBULINS AUnipath , Ltd.·Product code CZP·1987-10-13
K873870 — IMMUNOGLOBULINS GUnipath , Ltd.·Product code DEW·1987-10-13
K873871 — IMMUNOGLOBULINS MUnipath , Ltd.·Product code DFT·1987-10-13
K870200 — SUTTER FINGER JOINT PROSTHESISSutter Biomedical, Inc.·Product code KYJ·1987-10-09
K871177 — NTH 101 ULAragona Medical, Inc.·Product code FMT·1987-10-09
K871178 — MTC XI ULAragona Medical, Inc.·Product code FMT·1987-10-09
K871705 — LOW AIR LOSS BEDIntegrated Medical Equipment Co.·Product code FNM·1987-10-09
K872123 — CHURCHILL TPN ADMINISTRATION SETChurchill Corp.·Product code FPA·1987-10-09
K872231 — BARD EPICARDIAL ELECTRODE ARRAYC.R. Bard, Inc.·Product code DRF·1987-10-09
K872524 — SAFEWEIGH MAGIC SCALEHealth Care Innovations, Inc.·Product code FRW·1987-10-09
K872622 — ORTHODONTIC ARCHWonder Wire·Product code EJZ·1987-10-09
K872743 — BAXA TUBING SETS (FOR PHARMACY PUMP)Baxa Corp., Sub. of Cook Group, Inc.·Product code FMF·1987-10-09
K872771 — LOW PROFILE GASTROSTOMYMicrovasive·Product code KNT·1987-10-09
K872784 — MACTRODE-IIMarquette Electronics, Inc.·Product code DRX·1987-10-09
K872793 — DP-700 NIKMAN DEFIB-PADSNikomed U.S.A., Inc.·Product code LDD·1987-10-09
K872805 — NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEMSquibb-Novo, Inc.·Product code FMF·1987-10-09
K872924 — PARAGON 8500 CARDIO-PULMONARY BEDSurgi-Med, Inc.·Product code FNL·1987-10-09
K872927 — DAVOL INTRAOPERATIVE AUTOTRANSFUSION KITC.R. Bard, Inc.·Product code CAC·1987-10-09
K872954 — MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITORAequitron Medical, Inc.·Product code BZQ·1987-10-09
K873111 — CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.·Product code ITG·1987-10-09
K873181 — STRETCHER, WHEELED, MECHANICALCambridge Technologies, Inc.·Product code FPO·1987-10-09
K873280 — ENHANCE SUPPORT HOSEKimberly-Clark Corp.·Product code DWL·1987-10-09
K873337 — MODEL SSR1 HOLTER MONITORCardiodata Corp.·Product code DSH·1987-10-09
K873355 — MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KITMedix Biotech, Inc.·Product code CFT·1987-10-09
K873416 — MULTI-ACCESS REAGENT DISPENSERElectro-Nucleonics Laboratories, Inc.·Product code JQW·1987-10-09
K873421 — KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.·Product code FKQ·1987-10-09
K873477 — INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)Vortran Medical Technology 1, Inc.·Product code CCQ·1987-10-09
K873492 — BSK-1033 TELEMETRY MONITORING CABLEDesco Industries, Inc.·Product code DSA·1987-10-09
K873523 — PLAIN DRY GAUZEAbsorbent Cotton Co., Inc.·Product code EFQ·1987-10-09
K873528 — MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORSIntermedics, Inc.·Product code DXY·1987-10-09
K873687 — ANGIOMAT CT INJECTORMallinckrodt Group, Inc.·Product code DXT·1987-10-09
K873765 — FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METERNam Tai , Ltd.·Product code DSK·1987-10-09
K871553 — X-CALIBER MODEL 1000 BONE MINERAL ANALYZERHologic, Inc.·Product code KGI·1987-10-08
K872734 — MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICEPalomex Instrumentarium Corp.·Product code IZH·1987-10-08
K873193 — PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCSPharmacia, Inc.·Product code DHB·1987-10-08
K873420 — GLOBALCARE(TENS)Oms Medico, Inc.·Product code GZJ·1987-10-08
K873479 — COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206Lakewood Biochemical Co., Inc.·Product code JSJ·1987-10-08
K873480 — TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023Lakewood Biochemical Co., Inc.·Product code JSG·1987-10-08
K873481 — HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016Lakewood Biochemical Co., Inc.·Product code JSI·1987-10-08
K873482 — TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033Lakewood Biochemical Co., Inc.·Product code JSG·1987-10-08
K873483 — TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020Lakewood Biochemical Co., Inc.·Product code JSG·1987-10-08
K873549 — PEDIATRIC BELLOWSDraeger Medical, Inc.·Product code CBK·1987-10-08
K873646 — DIGIVIEWERDigivision, Inc.·Product code LLZ·1987-10-08
K873648 — BAHIA ALLERGEN DISCIncstar Corp.·Product code DHB·1987-10-08
K873827 — MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)Lakewood Biochemical Co., Inc.·Product code JSJ·1987-10-08
K863857 — PULSE-OXLife Design Systems, Inc.·Product code DQA·1987-10-07
K871990 — MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.Oxford Medilog, Inc.·Product code OLZ·1987-10-07
K872138 — MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIERFisher & Paykel Allied Products , Ltd.·Product code BTT·1987-10-07
K872179 — CODMAN NEUROLASE LASER SYSTEMCodman & Shurtleff, Inc.·Product code GEX·1987-10-07
K872280 — MODIFIED PHADEBAS RAST/PHADEZYM RASTPharmacia, Inc.·Product code DHB·1987-10-07
K872772 — OHMEDA BIOX 3740 PULSE OXIMETEROhmeda Medical·Product code DQA·1987-10-07
K873346 — MODEL 2240 SLAVE SCOPEMarquette Electronics, Inc.·Product code DPS·1987-10-07
K873474 — SUTURELESS TEMPORARY EPICARDIAL PACING LEADSymbion, Inc.·Product code LDF·1987-10-07
K873486 — RED TOP ALLERGEN DISCIncstar Corp.·Product code DHB·1987-10-07
K873488 — SILENT GUARD CAT. NO. SG-10American Omni Medical, Inc.·Product code DTL·1987-10-07
K873539 — ACA URINE DRUGS OF ABUSE CONTROLE.I. Dupont DE Nemours & Co., Inc.·Product code DIF·1987-10-07
K873573 — CIBA CORNING MAGIC LITE FERRITINCiba Corning Diagnostics Corp.·Product code DBF·1987-10-07
K873668 — MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.·Product code CEP·1987-10-07
K873676 — IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNITIncstar Corp.·Product code DHB·1987-10-07
K873727 — PULL-APART INTRODUCER (SHEATH)Quinton, Inc.·Product code DYB·1987-10-07
K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903)Simmler, Inc.·Product code CJE·1987-10-07
K873789 — QM300 TRANSFERRIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DDG·1987-10-07
K870051 — SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLEViratek, Inc.·Product code CAF·1987-10-06
K870567 — EVOPORT 300Dantec Electronics, Inc.·Product code GWF·1987-10-06
K871427 — (SPAG) MODEL SPAG-2 6000 SERIESViratek, Inc.·Product code CAF·1987-10-06
K871590 — VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & Hartson·Product code KTH·1987-10-06
K872206 — MD-104, POWERED MUSCLE STIMULATORElectro Med Supply, Inc.·Product code IPF·1987-10-06
K872207 — MS-108, POWERED MUSCLE STIMULATORElectro Med Supply, Inc.·Product code IPF·1987-10-06
K872208 — MS-112, POWERED MUSCLE STIMULATORElectro Med Supply, Inc.·Product code IPF·1987-10-06
K872253 — CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIASurgical Laser Technologies, Inc.·Product code HHR·1987-10-06
K872290 — BIO-LOGIC BANKERBio-Logic Systems Corp.·Product code GWK·1987-10-06
K872497 — MODEL MR-45 AMBULATORY HOLTER MONITOROxford Medilog, Inc.·Product code DSI·1987-10-06
K872733 — FIAX TEST KIT FOR MUMPS-G ANTIBODIESWhittaker Bioproducts, Inc.·Product code GRB·1987-10-06
K872780 — GUS TRAC C-303Gus Company, Inc.·Product code ITH·1987-10-06
K873133 — BNP-AMYLASE TESTSclavo, Inc.·Product code JFJ·1987-10-06
K873411 — SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084Lakewood Biochemical Co., Inc.·Product code JSH·1987-10-06
K873412 — GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038Lakewood Biochemical Co., Inc.·Product code JSJ·1987-10-06
K873413 — GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFRLakewood Biochemical Co., Inc.·Product code JTS·1987-10-06
K873524 — AFFINITY HCG IMMUNIT (POLYCLONAL)Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JHI·1987-10-06
K873675 — MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUADMedtronic Vascular·Product code GZB·1987-10-06
K873828 — CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990Lakewood Biochemical Co., Inc.·Product code JSF·1987-10-06
K872607 — INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17Randolph Engineering, Inc.·Product code HQZ·1987-10-05
K872857 — HOSPAL DIALYSATE FOR C.A.V.H.D.Delmed, Inc.·Product code KPO·1987-10-05

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