Atlas FDA

1981

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

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RecordFirmDate
IN-THE-EAR MODEL 101M (K812939)Danavox, Inc.1981-11-06
SURGICAL DRESSINGS (K812831)Foreign Trade Zone of Wisconsin1981-11-06
PILLING K KNIFE (K812918)Narco Scientific1981-11-06
FIAX RHEUMATOID FACTOR TEST KIT (K812968)Intl. Diagnostic Technology1981-11-06
MED-EX (K812899)Chattanooga Group, Inc.1981-11-06
SLICK ENDOTRACHEAL TUBE (K812943)Polamedco, Inc.1981-11-06
PORTABLE LIDOCAINE INFUSION PUMP (K812917)Cardiac Pacemakers, Inc.1981-11-06
RA LATEX TEST (K812972)Oxoid U.S.A., Inc.1981-11-06
MEDISYSTEMS NEEDLES & SYRINGES (K812910)Medisystems Corp.1981-11-06
SOFTCARE BARRIER WET DRESSING (K812736)The Kendal Co.1981-11-06
S/P SURE-CAP N (K812923)American Dade1981-11-06
PERSONAL MEDICATION INFUSER (K810850)Pacesetter Systems1981-11-06
IN-THE-EAR MODEL 821 (K812938)Danavox, Inc.1981-11-06
ACCURATE BETA (K812967)Organon, Inc.1981-11-06
BCYE MEDIUM (K812911)Gibco Laboratories Life Technologies, Inc.1981-11-06
S/P CAPILLARY TUBES, HEPARINIZED (3A) (K812970)American Dade1981-11-06
S/P SURE-CAP C (K812922)American Dade1981-11-06
KERMATH THERAPY SIMULATOR (K812726)Kermath Mfg. Corp.1981-11-05
AUTOMATED ELECTROCAUTERY SYSTEM (K812213)University of Washington1981-11-05
ENGSTROM ERICA (K812642)Lkb Instruments, Inc.1981-11-05
BODAI PATIENT COMMUNICATOR (K812720)Sontek Industries, Inc.1981-11-05
DRAWER TEST (K812713)Medmetric Corp.1981-11-05
TECHNICATOR (K812702)Cameron-Miller, Inc.1981-11-05
HERPES (K811021)Immuno-Diagnostic Products, Inc.1981-11-05
URICAR (K812700)Hi Chem, Inc.1981-11-05
SAFE GUARD (K812722)Concept, Inc.1981-11-05
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (K812727)Immuno Nuclear Corp.1981-11-05
MODEL 325C UNIPOLAR CARDIAC PULSE GEN. (K812832)Cook Pacemaker Corp.1981-11-05
DIGITRON (K812721)Siemens Corp.1981-11-04
TELECARE ISOTEC PRESSURE TRANSDUCER DOME (K812883)Narco Scientific1981-11-02
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C (K812556)American Dade1981-11-02
THE NEW 1600 ELECTRODE (K812878)Andover Medical, Inc.1981-11-02
PEDIATRIC MICROAGGREGATE BLOOD FILTER (K812874)Abbott Laboratories1981-11-02
CLEANING SOLUTION FOR RADIOMETER OSM2 (K812623)Fisher Scientific Co., LLC1981-11-02
SET FOR ASEPTIC DECANTING OF A FLEX I.V (K812852)Dip, Inc.1981-11-02
STERILE GAUZE PADS 12PLY (K812711)Medspec Corp.1981-11-02
POWER PACK (K812440)Black & Decker(Tm)1981-11-02
GILCHEM ALP REAGENT (K812912)Gilford Diagnostics1981-11-02
SORENSON THERMODILUTION CARDIAC COMPUT (K812757)Sorensen Research1981-11-02
SHILEY ARTERIAL FILTER W/40 MICRON SCREE (K812742)Shiley, Inc.1981-11-02
NARCO TELECARE PRESSURE TRANSDUCER DOME (K812884)Narco Scientific1981-11-02
STERILE LAPAROTOMY SPONGES-X-RAY DETECT (K812710)Medspec Corp.1981-11-02
DUAL MPC CHARGER (K812439)Black & Decker(Tm)1981-11-02
450/800 DRILL (K812436)Black & Decker(Tm)1981-11-02
SPHYGMOMANOMETER (K812409)Somatronix Research Corp.1981-11-02
WARMING LISTHTS #96H & 96HT (K812745)J. H. Emerson Co.1981-11-02
SAGITTAL SAW (K812438)Black & Decker(Tm)1981-11-02
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE (K812965)American Optical Corp.1981-11-02
FLOW-DIRECTED BALLOON THERMODILUTION (K812761)Nova Medical Specialties1981-11-02
GAUZE SPONGES (K812572)Worldwide Surgical Gauze1981-11-02
FEMEX (K812907)Promac1981-11-02
FE-CULT PLUS (K811752)Gamma Biologicals, Inc.1981-11-02
150 DRIVER REAMER (K812437)Black & Decker(Tm)1981-11-02
STERI-VAC #400C GAS STERILIZER (K812867)3M Company1981-11-02
MULTI-GRAM DEVELOPING TANK R-12 & R-3 (K812919)Marion Laboratories, Inc.1981-11-02
KENZ-GELECT (K812263)Suzuken Co., Ltd.1981-11-02
YARMO NASAL CARTILAGE SOFTENER (K812895)American V. Mueller1981-11-02
STERILE DISSECTOR SPONGES-X-RAY DETECT (K812707)Medspec Corp.1981-11-02
ANSWER (R) (K812924)Armkel, LLC1981-11-02
MODEL 325T PROGRAMMABLE PULSE GENERATOR (K812358)Cook Pacemaker Corp.1981-10-29
IMPLANTABLE VENTRICULAR-INHIBITED CARDI (K812790)Telectronics, Inc.1981-10-29
ADAPTAID #365-38 (K812756)Intermedics, Inc.1981-10-29
IMPROVED PLAYTEX TAMPON (K812870)Playtex, Inc.1981-10-29
HYDROXI-FLEX IMPLANT (K812321)Impladent1981-10-29
MODEL 841 ENDOCARDIAL TINED LEAD (K812816)Pacesetter Systems1981-10-29
XYLENE (K812847)Richard-Allan Medical Ind., Inc.1981-10-29
SOLARIUM COMBINATION (K812663)Tech-Pro, Inc.1981-10-29
MODEL 833 ENDOCARDIAL TINED LEAD (K812815)Pacesetter Systems1981-10-29
TEMPORARY PERVENOUS J-ATRIAL LEAD (K812781)Cordis Corp.1981-10-29
CLEAR-RITE II (K812846)Richard-Allan Medical Ind., Inc.1981-10-29
ELUAID (K812002)Ortho Diagnostic Systems, Inc.1981-10-28
MOXALACTAM 30 MCG. SENSITIVITY DISCS (K812228)Difco Laboratories, Inc.1981-10-28
INTERMEDICS PROGRAMMER, MODEL 522-03 (K812813)Intermedics, Inc.1981-10-27
IMED MODEL 970 & 975 VOL. INFUSION PUMP (K812823)Imed Corp.1981-10-27
S/P SERUM DROPPER PIPETS (K812892)American Dade1981-10-27
INTERMEDICS ADAPTAID STEP-DOWN ADAPTER (K812812)Intermedics, Inc.1981-10-27
PRESSURE DISC COMPONENT FOR ACCUSET (K812824)Imed Corp.1981-10-27
IMMUNEX CRP (K812881)Armkel, LLC1981-10-26
THORACIC DRAINAGE SET #55-DB2-G (K812746)J. H. Emerson Co.1981-10-26
IDS PORPHYRIN REAGENT (K812859)Innovative Diagnostic Systems, Inc.1981-10-26
FLO-COR I (K812825)Biotrine Corp.1981-10-26
ACMI BIPOLAR HEMOSTATIC SOURCE (K812637)American Cystocope Makers, Inc.1981-10-26
OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (K812872)Instrumentation Laboratory CO1981-10-26
EXTENSIONS-LUSATZTISCH (K812779)The Telos Co.1981-10-26
RHEUMATEX (K812882)Armkel, LLC1981-10-26
OXEQUIP CONDUCTIVE & NON ANES. BREATH (K812624)Oxequip Health Ind.1981-10-26
PENASE (K812877)Analytab Products, Inc.1981-10-26
WHISK-R (K812694)Medi-Spec1981-10-26
REPLACEABLE BATTERY PERFECTEMP 2 CAUT (K812644)Key Medical, Inc.1981-10-26
H-103 IGG, H-104 IGA, H-105 IGM (K812821)Immulok, Inc.1981-10-26
API GERM TUBE (K812862)Analytab Products, Inc.1981-10-26
FORCEP (K812205)Reznik Instruments1981-10-26
IMMUNOASSAY PLATE (K812860)Skatron, Inc.1981-10-26
STERILE DENTAL ROLL (K812709)Medspec Corp.1981-10-23
INJECTION CAP, LUER LOCK (K812657)Procedure Products, Inc.1981-10-23
MEDTRONIC #4951 (K812599)Medtronic Vascular1981-10-23
ACCRA LAB HEMOTOLOGY (K812848)Accra Laboratories, Inc.1981-10-23
NUCLEAR ANTIGENS (K810592)Alpha Antigens, Inc.1981-10-23
TITERTEK AUTODROP (K812818)Flow Laboratories, Inc.1981-10-23
HELENA COLOSCREEN METHOD (K812428)Helena Laboratories1981-10-23
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Every clearance here is in the API, with alerts when new ones post.