Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WOODLYN CLASSIC KERATOMETER (K841767)Woodlyn, Inc.1984-08-07
WOODLYN CLASSIC JAVAL OPHTHALMOMETER (K841764)Woodlyn, Inc.1984-08-07
ROOTMAN ORBITAL SURGERY INSTRUMENT SET (K842697)Downs Surgical , Ltd.1984-08-07
IVAC 280 VOLUMETRIC INFUSION CONTROLLER (K842419)Y1984-08-07
WOODLYN CLASSIC SLIT LAMP HSSL-CL (K841761)Woodlyn, Inc.1984-08-07
WOODLYN STANDARD SLIT LAMP HSSL-ST (K841765)Woodlyn, Inc.1984-08-07
DECARBOXYLASE TEST REAGENT (K842869)Irvine Diagnostic Services1984-08-07
T- EXTENSION SET T-04-C (K842985)Tico Medical Instruments, Inc.1984-08-07
NEOS LP (K841633)Biotronik Sales, Inc.1984-08-06
DESERET DISPOSABLE PRESSURE TRANSDUCER (K841968)Parke-Davis Co.1984-08-06
INFUSAID INFUSE-A-PORT (K842355)Infusaid Corp.1984-08-06
SALINE, 1.3% W/O PRESERVATIVE (K842723)E K Ind., Inc.1984-08-03
LIMONENE (K842721)E K Ind., Inc.1984-08-03
SCANLAN ENDARSECTOR (K841521)Scanlan Intl., Inc.1984-08-03
WRIGHTS STAIN SOLUTION (K843051)Reagent Laboratory, Inc.1984-08-03
VOGES-PROSKAUER REAGENT A (K842870)Irvine Diagnostic Services1984-08-03
PALL EC PLUS FILTER W/FILTER SLEEVE (K834382)Pall Biomedical Products Co.1984-08-03
SOLUTION CLARIFICATION UNIT (K842141)Pall Biomedical Products Co.1984-08-03
DECALCIFIER SOLUTION (K842726)E K Ind., Inc.1984-08-03
AIR SHIELDS AS461 MONITORING SYS (K842321)Air-Shields, Inc.1984-08-03
GENTIAN VIOLET (K842730)E K Ind., Inc.1984-08-03
TUBULAR HOLLOW FIBER MEMBRANE (K841476)American Bentley1984-08-03
CAVI-MED (K842581)Cooper Lasersonics, Inc.1984-08-03
SUPERMOUNT (K842727)E K Ind., Inc.1984-08-03
COBE EMERGENCY POWER SOURCE 43610-000 (K842138)Cobe Laboratories, Inc.1984-08-03
HIPPURATE TEST DISKS (K842868)Irvine Diagnostic Services1984-08-03
PALL EC PLUS FILTER (K834380)Pall Biomedical Products Co.1984-08-03
IMMUSTAPH LATEX AGGLUTINATION KIT (K842709)Immucell Corp.1984-08-03
LITHIUM PACEMAKER 811-811L & 811XL (K840748)Omikron Scientific, Ltd.1984-08-03
ARTERIAL EMBOLECTOMY CATHETER (K840198)Shiley, Inc.1984-08-03
BRAIN HEART INFUSION BROTH (K842852)Anarobe Systems1984-08-03
POROUS HYDROXYAPATITE BG200 (K841201)Interpore Intl.1984-08-03
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (K842328)Bartels Immunodiagnostic Supplies, Inc.1984-08-03
ZENKERS SOLUTION (K842732)E K Ind., Inc.1984-08-03
SALINE, 0.85%W/PRESERVATIVE (K842725)E K Ind., Inc.1984-08-03
MULTIPLE PLANETAMED;PLANETA HYDROMASS (K842941)Planeta Hausgeraete KG1984-08-03
MEDTRONIC 6210 PERMANENT LEAD INTRODUC (K842780)Medtronic Vascular1984-08-03
SALINE 0.85% W/O PRESERVATIVE (K842724)E K Ind., Inc.1984-08-03
MODEL 866 PERMATHANE BIPOLAR, COAXIAL (K841739)Pacesetter Systems1984-08-03
MODEL 110-5 & 140-8 (K842005)Camino Laboratories, Inc.1984-08-03
INDOLE REAGENT (K842872)Irvine Diagnostic Services1984-08-03
LEPTOS (K841635)Biotronik Sales, Inc.1984-08-03
VOGES-PROSKAUER REAGENT B (K842867)Irvine Diagnostic Services1984-08-03
BUF-FIX (K842728)E K Ind., Inc.1984-08-03
ELECTROCARDIOGRAPH E-340 (K840440)Burdick Corp.1984-08-03
LYSINE IRON AGAR (K842853)Anarobe Systems1984-08-03
TRYPTICASE SOY BROTH (K842849)Anarobe Systems1984-08-03
CHRISTENSEN'S UREA AGAR (K842855)Anarobe Systems1984-08-03
CENTRIMED SYSTEM 1 (K842007)Centrimed Corp.1984-08-03
NICOLET VIKING (K842956)Nicolet Biomedical Instruments1984-08-03
DECOLORIZING FLUID (K842729)E K Ind., Inc.1984-08-03
VAN-TEC URETERAL DILATION BALLOON CATH (K841940)Van-Tec, Inc.1984-08-03
IMPACT MODEL 316 (K842050)Impact Instrumentation, Inc.1984-08-03
FASTPASS IMPLANTABLE ENDOCARDIAL PAC (K841885)Pacesetter Systems1984-08-03
CARDIOPLEGIA RESERVOIR CAS-2000 (K841938)American Bentley1984-08-03
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (K842701)Downs Surgical , Ltd.1984-08-02
ISLAM BONE MARROW ASPIRATION NEEDLES (K842699)Downs Surgical , Ltd.1984-08-02
CHERMEL OSTEOTOMES (K842823)Cher Mel Corp.1984-08-02
CHERMEL BONE CHISELS (K842824)Cher Mel Corp.1984-08-02
APOLLO AIR FLUIDIZED BED (K842987)Apollo Fluid Dynamics1984-08-02
CHERMEL BONE GOUGES (K842822)Cher Mel Corp.1984-08-02
POST-AID (K840907)E.W. Link, Inc.1984-08-02
MONTG. LARYNGEAL KEEL (K842800)Boston Medical Products, Inc.1984-08-02
ULTRA LYTE ANALYZER I 100 (K842315)Ultra Quest Diagnostics, Inc.1984-08-02
BASE METAL ALLOY (K842551)Dentsply Intl.1984-08-02
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT (K842623)Syva Co.1984-08-02
PDA SYSTEM (K842522)Abbott Laboratories1984-08-02
ALLIED ASSOC. THERAPEUTIC EXERCISE (K842433)Allied Associates, Inc.1984-08-02
ROSENBERG SKIN GRAFTING KNIVES (K842702)Downs Surgical , Ltd.1984-08-02
SEBUTAPE (K840096)Cuderm Corp.1984-08-02
AMER. HISTO-ID SYS PRIMARY IGM S7920-31 (K842327)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
CONFERETTE C2 (K840893)Siemens Hearing Instruments, Inc.1984-08-02
TIDAL DISTENSION IRRIGATION SET (K841362)Abbott Laboratories1984-08-02
GENETIC SYS LEGIONELLA IMMUNOFLURORES (K842683)Genetic Systems Corp.1984-08-02
QUINTON 901 & 900 HOLTER SCANNER (K841611)Quinton, Inc.1984-08-02
WOODLYN SLIT LAMP HSSL-EC (K841763)Woodlyn, Inc.1984-08-02
PRISM-FINE (K840652)Dentsply Intl.1984-08-02
EARLY DETECTOR (K833369)Warner-Lambert Co.1984-08-02
SURGICAL HEADLIGHT (K842515)Good-Lite Co.1984-08-02
ALLIED ASSOC. THERAP. EXERCISE EQUIP (K842430)Allied Associates, Inc.1984-08-02
ACU-DERM TRANSPARENT INCISE DRAPE (K841735)Acme United Corp.1984-08-02
AMER. HISTO-ID SYS PRIMARY IGG S7920-11 (K842329)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
DISPOSABLE SURGERY HOOD (K842438)Anago, Inc.1984-08-02
ASCORBIC ACID (K842215)Organon Teknika Corp.1984-08-02
WOODLYN APPLANATION TONOMETER (K841762)Woodlyn, Inc.1984-08-02
COBE AEPS (K842054)Cobe Laboratories, Inc.1984-08-02
DISPOSABLE PREPING PAD (K842453)Anago, Inc.1984-08-02
AMER. HISTO-ID SYS PRIMARY KIT (K842326)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
AMER. HISTO-ID SYS PRIMARY IGA 2720-21 (K842330)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
PARTIALLY THREADED BONE FIX. PIN (K842293)Warsaw Orthopedic, Inc.1984-08-02
GX CEPH (K842463)Gendex Corp.1984-08-02
ALLIED ASSOC. THERAPEUTIC EXER EQUIP- (K842429)Allied Associates, Inc.1984-08-02
PCI W/CATH-SEAL SIDE FLOW FITTING (K842259)Universal Medical Instrument Corp.1984-08-01
ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP (K842428)Allied Associates, Inc.1984-08-01
ULTRAMED 11S601 (K842801)Robert Bosch Corp.1984-08-01
AXIOM FEMORAL VENUS CATHETER (K842084)Axiom Medical, Inc.1984-08-01
ALLIED ASSOC. THERAP. EXERCISE EQUIP- (K842431)Allied Associates, Inc.1984-08-01
MT-700 MT-750 FT-350 (K842704)Cryomedics, Inc.1984-08-01
VACOMED 4 (K842802)Robert Bosch Corp.1984-08-01
ALL-HANDS STERILE FIELD-0201 (K842545)All-Hands Medical Supply, Inc.1984-08-01
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Every clearance here is in the API, with alerts when new ones post.