Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COBEAU (K812548)Sci-Pharm, Inc.1981-09-25
SWAN-GANZ & EDSLAB HEPARIN COATED CATH. (K812563)American Edwards Laboratories1981-09-25
VELCRO FINGER/TOE SPLINT (K812654)Maddak, Inc.1981-09-25
FLOW-DIRECTED THERMODILUTION CATHETER (K812324)Sorensen Research1981-09-25
BEAUSEAL (K812549)Sci-Pharm, Inc.1981-09-25
DISPOSABLE ELECTRODE, #1610 (K812276)Andover Medical, Inc.1981-09-25
VENTI-MONITOR MODEL 101 (K812041)Medix Medical Electronics (U.S.A.), Inc.1981-09-25
KONTRON PMS 7000 (K812354)Kontron Instruments, Inc.1981-09-25
BEAUFILL (K812545)Sci-Pharm, Inc.1981-09-25
ADAPTIC* C.F.S. (K812449)Johnson & Johnson Professionals, Inc.1981-09-25
SORENSON SUBCLAVIAN CATHETER SSC-8 (K812326)Sorensen Research1981-09-25
2000 SERIES PORTABLE RESUSCITATION SYST. (K812519)Life Science Instrumentation, Inc.1981-09-25
CARDIORATER CR-5 (K812146)Life Science Instrumentation, Inc.1981-09-25
SPIROMETER 210/211 (K812039)Medix Medical Electronics (U.S.A.), Inc.1981-09-25
280/4 MINI-DEFIBRILLATOR (K812520)Life Science Instrumentation, Inc.1981-09-25
CAVITRON (K812568)G-C Intl. Corp.1981-09-25
SHERWOOD WATER TRAP (K812569)Sherwood Medical Co.1981-09-25
VELCRO SPLINT STRAP FASTENERS (K812655)Maddak, Inc.1981-09-25
ULTRA ZYME PLUS GOT #64953, 65033 & 34 (K812592)Harleco1981-09-24
THE ARTHROFILE (K812506)Dyonics, Inc.1981-09-24
CAROTID ARTERY CLAMP & TOOLS (K811821)New England Surgical Instrument Corp.1981-09-24
TOWNLEY UNICONDYLAR KNEE (K812012)Depuy, Inc.1981-09-24
LACTIC ACID DIALYSATE ADDITIVE (K811706)Edlaw Pharmaceuticals, Inc.1981-09-24
INFANT APNEA MONITOR MODEL 100 (K812045)Medix Medical Electronics (U.S.A.), Inc.1981-09-24
ULTRA ZYME PLUS GPT, #64956, 65035 & 36 (K812591)Harleco1981-09-24
DELTA-A.V. FISTULA CANNULATION SET (K812621)Amisco Trading Corp.1981-09-24
HDL CHOLESTEROL REAGENT (K812574)Pointe Scientific, Inc.,1981-09-24
HEMODIALYSIS TRANSDUCER PROTECTOR (K812162)Membrana1981-09-24
HEMODIALYSIS VENOUS & ARTERIAL SET (K812622)Amisco Trading Corp.1981-09-24
CORDIA IM (K812540)Cordis Corp.1981-09-24
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (K812227)Clinical Assays, Inc.1981-09-24
CELL-CHEX RBC (K811741)Streck Laboratories, Inc.1981-09-24
BOVINE CHEMISTRY CONTROL I.X. & II.X. (K812583)American Dade1981-09-24
FOAM WEDGE (K812482)Maddak, Inc.1981-09-24
ULTRA ZYME PLUS LDH #64950, 65038 & 39 (K812590)Harleco1981-09-24
LAPIN CLEAR CUT II (K812125)Promed Corp.1981-09-24
TOMAC STERILE DISP. LAP SPONGE (K812554)American Convertors Div., American Pharmaseal1981-09-24
LOW FIBRINOGEN CONTROL (K812108)Bio/Data Corp.1981-09-24
ULTRA CHEM E-TRIG #65024 (K812589)Harleco1981-09-24
BOSCH HEARING INSTRUMENTS (K812503)Retlif, Inc.1981-09-24
GER 540, GER 541 MANUAL BED (K812600)G.W. Healthcare, Inc.1981-09-23
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY (K811464)Intermedics, Inc.1981-09-23
CYTOMEGELISA TEST KIT (K812123)M.A. Bioproducts1981-09-23
AQUEOUS BLOOD GAS CONTROLS (K812553)Fisher Scientific Co., LLC1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (K812487)Dako Corp.1981-09-23
TELEMETRY DECODER (K801339)Intermedics, Inc.1981-09-23
LINDE MARK II (K812536)Union Carbide Corp.1981-09-23
BECKMAN R.PR CONTROL SERUM SET (K812425)Beckman Instruments, Inc.1981-09-23
PADAC (K812458)Calbiochem-Behring Corp.1981-09-23
ALPHA PLASTIC PLASMA BOTTLE (K810897)Alpha Therapeutic Corp.1981-09-23
COROMETRICS MEDICAL SYST. 220 PH ANALY. (K812552)Transidyne General Corp.1981-09-23
PAC-AID (K812454)Albert J. Anthony, Dmd1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO (K812493)Dako Corp.1981-09-23
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY (K812338)Terumo Medical Corp.1981-09-23
DALE COMBO TRACHEOSTOMY TUBE HOLDER (K812429)Dale Medical Products, Inc.1981-09-23
BLOOD FREEZING BAG (K810500)Delmed, Inc.1981-09-23
ACCRA LAB WRIGHT STAIN (K812504)Accra Laboratories, Inc.1981-09-23
AMES TDA THEOPHYLLINE TEST (K812518)Miles Laboratories, Inc.1981-09-23
EM-X (K812222)Biological Corp. of America1981-09-23
TITERTEK MICROPLATE INCUBATOR (K812340)Flow Laboratories, Inc.1981-09-23
FACTOR VIII DEFICIENT PLASMA #B8D (K812431)Sigma Chemical Co.1981-09-23
RABBIT COMPLEMENT (K812522)Dutchland Laboratories, Inc.1981-09-23
BEAUBON (K812547)Sci-Pharm, Inc.1981-09-23
SCRIPPSYSTEM IMMUNOGLOBIN RID KIT (K812453)Scripps-Miles, Inc.1981-09-23
PROTEIN-BASED BLOOD GAS CONTROL (K812541)American Dade1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG (K812489)Dako Corp.1981-09-23
SKIN ADHESIVE-50XX (K812249)Manfred Sauer Corp.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 (K812490)Dako Corp.1981-09-23
SENSI-TECT (K812581)Uti-Tect, Inc.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN (K812492)Dako Corp.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA (K812488)Dako Corp.1981-09-23
CARTMILL/BARRY FEEDING TUBE (K812427)Impra, Inc.1981-09-23
ULTRACHEM URIC ACID ALDH, ITEM #65047 (K812500)Harleco1981-09-23
CYBERLITH IX IMPLANTABLE PULSE GENERATOR (K801337)Intermedics, Inc.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL (K812486)Dako Corp.1981-09-23
MEDTRONIC MODEL 2409 (K812580)Medtronic Vascular1981-09-23
IMMULIK STAIN PLATE (K812497)Immulok, Inc.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA (K812495)Dako Corp.1981-09-23
CANCEL (K812582)Bio Systems, Inc.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 (K812491)Dako Corp.1981-09-23
CAMPY THIOGLYCOLLATE (TUBE) (K812451)Granite Diagnostics, Inc.1981-09-23
BEAUCOR (K812551)Sci-Pharm, Inc.1981-09-23
DIAGNOSTIC KITS & KIT COMPONENTS (K812434)Diagnostica, Inc.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM (K812496)Dako Corp.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO (K812494)Dako Corp.1981-09-23
FORAMATRON APICAL FORAMEN LOCATOR (K811995)Parker Laboratories, Inc.1981-09-21
ZEE EXTRICATION DEVICE (K812342)Zee Medical Products Co., Inc.1981-09-21
NIVP MONITOR (K812259)Datascope Corp.1981-09-21
THE EMMETT IUD THREAD RETRIEVER (K811761)Proto-Med, Inc.1981-09-21
RELIANCE OPHTHALMIC INSTRUMENT CONTROL (K812544)F. & F. Koenigkramer1981-09-21
HIFLO-HP (K812457)Tri-Med, Inc.1981-09-21
USCI TRANSTHORACIC TEMP. PACING ELECTROD (K812307)C.R. Bard, Inc.1981-09-21
KOI DIAMOND KNIFE (K812450)Koi, Inc.1981-09-21
LINGUAL BRACKET (K812300)American Ormco1981-09-21
PRESET FLOWMETER (K812419)Timeter Instrument Corp.1981-09-21
C-DAK DUO-FLUX ARTIFICIAL KIDNEY (K811830)Cordis Corp.1981-09-21
CAVITY VARNISH (K810913)Dentsply Intl.1981-09-21
PORTAPULSE (K812131)Gavon, Inc.1981-09-21
IMPROVED PLAYTEX TAMPON (K812534)Playtex, Inc.1981-09-21
LENSINE EXTRA STRENGTH CLEANER (K812433)CooperVision, Inc.1981-09-21
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