Atlas FDA

1981

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

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RecordFirmDate
MDM ARTERIAL BLOOD GAS SYRINGE (K812560)Martell Medical Products, Inc.1981-10-09
LDH REAGENT SET (K812836)Anco Medical Reagents & Assoc.1981-10-09
TOTAL CALCIUM REAGENT SET (K812835)Anco Medical Reagents & Assoc.1981-10-09
UTERINE ASPIRATION CURETTES(RIGID&FLEX) (K812426)Medi-Spec1981-10-08
FLEXFLOAT HEATER (K812682)Pharmaquest Corp.1981-10-08
ACA ANTITHROMBIN III TEST PACK (K812627)E.I. Dupont DE Nemours & Co., Inc.1981-10-08
ADULT FLEX FLOAT W/HEATER (K812681)Pharmaquest Corp.1981-10-08
SUNTANNING HOME UNIT (K812579)Tannhut1981-10-08
DOTRICH ELECTRONIC AIR CLEANER #C500AM (K812656)Leedal, Inc.1981-10-08
HEMA 20 MICRON TRANSFUSION BLOOD FILTER (K812697)Abbott Laboratories1981-10-08
ISOLATED VOLTAGE/FREQUENCY CONVERTER (K812619)Bio-Feedback Systems, Inc.1981-10-08
ADULT FLEXFLOAT (K812684)Pharmaquest Corp.1981-10-08
ACA FIBRINOGEN TEST PACK (K812629)E.I. Dupont DE Nemours & Co., Inc.1981-10-08
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM (K812155)Medtronic Vascular1981-10-08
SELF-CENTERING HIP (K812672)Depuy, Inc.1981-10-08
TANARAMA (K812543)Marketing Consultants of America1981-10-08
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL (K812245)Intermedics, Inc.1981-10-06
RIA QUANT C-PEPTIDE KIT (K812689)Mallinckrodt Critical Care1981-10-06
DESERET CATHETER DRESSING (K812073)Warner-Lambert Co.1981-10-06
G-C IMPRESSION SYRINGE (K812680)G-C Intl. Corp.1981-10-06
INTERMEDICS POLY FLEX EPICARDIAL SUTURE (K812221)Intermedics, Inc.1981-10-06
DI-CROWN (K812441)Coburn Optical Ind., Inc.1981-10-06
GC DISK (K812698)Remel Co.1981-10-06
AMYLASE (K812699)Pointe Scientific, Inc.,1981-10-06
MEZLOCILLIN 75 MCG. SENSI-DISC (K812571)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-10-06
MYOCATH CATOLOG NO. MCK-A (K812052)Sorensen Research1981-10-06
PROSANA BELT (K812719)Bandwagon, Inc.1981-10-06
EXAFLEX IMPRESSION MATERIAL (K812406)G-C Intl. Corp.1981-10-06
G-C FIT-CHECKER IMPRESSION MATERIAL (K812679)G-C Intl. Corp.1981-10-06
C-PEPTIDE CONTROL PACK (K812690)Mallinckrodt Critical Care1981-10-06
MONO 2 OXYGEN MONITOR (K812587)Kantron Cardiovascular, Inc.1981-10-06
KORICLEAN (K812176)Trans World Agency, Inc.1981-10-05
ANEMIA CONTROL (K812635)Environmental Chemical Specialties1981-10-02
SQC BUFFER (K812601)Transidyne General Corp.1981-10-02
QI 1150-1T INFUSION T (K812688)Quinton, Inc.1981-10-02
EMIT AUTO CAROUSEL (K812647)Syva Co.1981-10-02
ASSURE NATURAL FIT TAMPON (K812618)Personal Products Co.1981-10-02
ISOCENTRIC NEUTRON THERAPY SYSTEMS (K812337)The Cyclotron Corp.1981-10-02
ELEGANCE (K812578)Qualitone1981-10-02
OPRAFLEX (K812501)Selomas, Inc.1981-10-02
SANDARE FAST 340 PHOSPHORUS PROCEDURE (K812670)Sandare Chemical Co., Inc.1981-10-02
UNICUFF (K812639)Frontier Products1981-10-02
SUNTANNING DEVICE (SEPAR. FROM K812225) (K812521)Klafs Sunlight Corp.1981-10-02
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO (K812611)Kallestad Laboratories, Inc.1981-10-02
CI-TROL HEPARIN CONTROLS, LOW/HIGH (K812424)American Dade1981-10-02
SR-ALGICAP (K811867)J. Aderer, Inc.1981-10-02
THYROXINE (T4) 125I (K812666)Pcl-Ria, Inc.1981-10-02
TENCKHOFF PERITONEAL CATHETERS (K812607)Quinton, Inc.1981-10-02
DELTASCAN 2060 CT SCANNER (K812410)Technicare Corp.1981-10-02
BRIGHAM II TOTAL HIP SYSTEM (K812687)Hexcel Medical1981-10-02
VASCULAB #R12B (K812608)Medasonics, Inc.1981-10-02
MLA ELECTRA 700 (K812124)Medical Laboratory Automation Systems, Inc.1981-10-02
MEZLOCILLIN 75 MCG. SENSITIVITY DISCS (K812525)Difco Laboratories, Inc.1981-10-02
ULTRA ZYME PLUS AMYL #64982 & 65031 (K812594)Harleco1981-10-02
UNI-THANE (K812448)Unicare Systems, Inc.1981-10-02
MINITECK ENTERIC BROTH & ENTEROBACTER (K812286)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-10-02
SURGICAL BLADES & SCAPELS (SMPL. W/510K) (K812516)Needle Industries(Usa), Inc.1981-10-02
URE SIL EMBOLECTOMY/THROMBECTOMY CATH (K812640)Uresil Corp.1981-10-02
OMNIMEDICAL QUAD I (K812400)Omnimedical1981-10-02
VASCULAB #VSC21 (K812609)Medasonics, Inc.1981-10-02
SURGICAL RETRACTOR & ELASTIC STAYS, DISP (K812562)Humboldt Products1981-10-02
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (K812593)Harleco1981-10-02
CARDIAC REVIEW STATION (K812515)Diasonics, Inc.1981-10-02
FIBER OPTIC LIGHT SOURCE I (K812605)Venture Technology, Inc.1981-10-02
EMBRITROL CK-MB CONTROLS (K812671)Intl. Immunoassay Laboratories, Inc.1981-10-02
LABCER FIBRINOGEN ASSAY KIT & CALIBR. (K812570)Sherwood Medical Co.1981-10-02
BIOVATION URINALYSIS REPORTER (K812604)Biovation, Inc.1981-10-02
SEATTLE II TOTAL HIP SYSTEM (K812669)Hexcel Medical1981-10-02
LOXLEY EMERGENCY CERVICAL COLLAR (K812019)Loxley Medical1981-10-02
ACA IMMUNOGLOBULIN G ANALYTICAL TEST (K812664)E.I. Dupont DE Nemours & Co., Inc.1981-10-02
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM (K812641)Reagents Applications, Inc.1981-10-02
UNITEST-POTASSIUM (K812677)Biodynamics Corp.1981-10-02
VITROGEN TM 100 (K812617)Collagen Corp.1981-10-02
ACA IMMUNOGLOBULIN G CALIBRATOR (K812630)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
CLIRANS TE12 HOLLOW FIBER DIALYZER (K812498)Terumo Medical Corp.1981-09-29
FIBER OPTIC LIGHT SOURCE (K812202)Reznik Instruments1981-09-29
CEA CONTROL PLASMA (K812658)Pacific Hemostasis1981-09-29
ACA IMMUNOGLOBULIN A/M CALIBRATORS (K812633)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE (K812685)Ericka1981-09-29
ULTRA CHEM E-GLU #64976 & 65040 (K812595)Harleco1981-09-29
PLATELET AGITATOR (K812533)Helmer Labs, Inc.1981-09-29
ACA IMMUNOGLOBIN A TEST PACK (K812631)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
AFB STAIN SET (K812668)Carr-Scarborough Microbiologicals, Inc.1981-09-29
ACA IMMUNOGLOBIN M TEST PACK (K812632)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
INSUFFLATOR (K812200)Reznik Instruments1981-09-29
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA (K812661)Dako Corp.1981-09-29
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA (K812662)Dako Corp.1981-09-29
EHTOX GASTRIC LAVAGE KIT #2050 & #2070 (K812648)Ethox Corp.1981-09-29
TISSUE-TEK III ACCU-CUT ROTARY MICROTOME (K812558)Miles Laboratories, Inc.1981-09-29
RABBIT COAGULASE PLASMA (K812602)Dutchland Laboratories, Inc.1981-09-29
ACA PLASMINOGEN TEST PACK (K812625)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
DIALYSATE CONCENTRATE (K812330)Central Biological Co.1981-09-29
ULTRA ZYME PLUS ALP #64962, 65029 & 30 (K812596)Harleco1981-09-29
A.D.T. PROCEDURES TRAY (K812297)A.D.T. Lab Industries1981-09-28
BEAUCAV (K812550)Sci-Pharm, Inc.1981-09-25
EXMOOR AURAL GROMMET AG/TI (K812459)Exmoor Plastics , Ltd.1981-09-25
CENTERAL MONITOR 360 (K812144)Life Science Instrumentation, Inc.1981-09-25
CARDIORATER CR-3 (K812145)Life Science Instrumentation, Inc.1981-09-25
BEAUDENT (K812546)Sci-Pharm, Inc.1981-09-25
CARDIORATER CR-7 (K812147)Life Science Instrumentation, Inc.1981-09-25
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