Atlas FDA

1982

3,408 FDA 510(k) clearances · Clearance year

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RecordFirmDate
UNIVERSAL SLING, SLING & SWATHE (K823664)Warm & Form, Orthopedic Materials1982-12-30
INJECTION FILL TUBE (K823238)Vetrex Medical Corp.1982-12-30
DISPOSABLE TOOTH BRUSH (K823626)Fred Sammons, Inc.1982-12-30
CHOLESTEROL REAGENT (K823500)Ac Biochemical Laboratories, Inc.1982-12-30
ANTI SERA TO HUMAN OROSCOMUCOID (K823765)Kent Laboratories, Inc.1982-12-30
ROTATION BOOT (K823665)Warm & Form, Orthopedic Materials1982-12-30
MON-A-THERM MYOCARDIAL TEMP. SENSOR (K823435)Burditt & Calkins-Siemens-Elema1982-12-30
PERFILM MEMBRANE DRESSING (K822467)Chesebrough-Pond'S U.S.A. Co.1982-12-30
ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (K822240)American Mcgaw1982-12-30
PHADEBACT CSF TEST 20 (K822810)Pharmacia, Inc.1982-12-30
VENOUS RESERVOIR BAG #BMR-1400 (K823272)Bentley Laboratories, Inc.1982-12-30
VERTEX MONITORING CATHETER (K823253)Vertex Medical Corp.1982-12-30
RIB BELT (UNIVERSAL) (K823662)Warm & Form, Orthopedic Materials1982-12-30
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- (K823584)Brentwood Instruments, Inc.1982-12-30
UNIVERSAL BUCKS TRACTION (K823660)Warm & Form, Orthopedic Materials1982-12-30
BACKSTOP VALVE W/SIDE ARM (K823190)Vertex Medical Corp.1982-12-30
ELECTROCARDIOGRAPH #334 (K823488)Birtcher Corp.1982-12-30
ABDOMINAL BINDER (K823663)Warm & Form, Orthopedic Materials1982-12-30
MOUTH STICK KIT (K823625)Fred Sammons, Inc.1982-12-30
CERVICAL COLLAR (K823667)Warm & Form, Orthopedic Materials1982-12-30
CLAVICLE SUPPORT (K823661)Warm & Form, Orthopedic Materials1982-12-30
MYOTEST NERVE STIMULATOR (K823583)Prothia USA, Inc.1982-12-30
NEUROMEDICS PACETRON HEART RATE MONITOR (K823290)Intermedics, Inc.1982-12-30
ESA CAMERA (K823516)Concept, Inc.1982-12-30
PICTURES & WORD IDENTIFICATION CVA PAT (K823608)Fred Sammons, Inc.1982-12-30
MODEL 8300 TESTER (K823197)Medicon, Inc.1982-12-30
CLEAR VINYL MONITORING CONNECTOR (K823340)Vertex Medical Corp.1982-12-30
HOLTER KIT MODEL #5000 SERIES (K823414)Andover Medical, Inc.1982-12-30
ENZYMATIC GLUCOSE DETERMINATION (K823474)The Dow Chemical Co.1982-12-30
ELECTRODE, PACEMAKER, PERMANENT (K823033)Pacesetter Systems1982-12-30
TUOHY-BORST ADAPTER W/SIDE ARM (K823192)Vertex Medical Corp.1982-12-30
HOLDER FOR MOUTH STICK (K823624)Fred Sammons, Inc.1982-12-30
TERUFUSION THREE-WAY STOPCOCK (K823469)Terumo Medical Corp.1982-12-30
PELVIC TRACTION BELT (K823659)Warm & Form, Orthopedic Materials1982-12-30
REUSABLE METAL STOPCOCK (K823254)Vertex Medical Corp.1982-12-30
MODELS DPT 1000/DPT 1000NS (K823286)Bio-Med Corp.1982-12-30
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT (K822944)Travenol Laboratories, S.A.1982-12-30
FORMED STEEL DEVICE KEEP LEGS SEPARATED (K823629)Fred Sammons, Inc.1982-12-30
INSULATED THERMOELASTOMER MITT (K823622)Fred Sammons, Inc.1982-12-30
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS (K822818)Marquette Electronics, Inc.1982-12-30
OXYGENATORS #BOS-10, 105, 5S (K823456)Bentley Laboratories, Inc.1982-12-30
JACKET & SET (K823533)Shiley, Inc.1982-12-30
BENZING RETROGRADE ADMIN. SET (K823373)Beech Medical, Inc.1982-12-30
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM (K823567)Syva Co.1982-12-30
DELUXE KNEE IMMOBILIZER(UNIVERSAL) (K823658)Warm & Form, Orthopedic Materials1982-12-30
UNIVERSAL WRIST SPLINT & FOREARM SPLINT (K823666)Warm & Form, Orthopedic Materials1982-12-30
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE (K823256)Vertex Medical Corp.1982-12-30
DISPOSABLE PLASTIC STOPCOCK (K823191)Vertex Medical Corp.1982-12-30
IMMUNOGLOBULIN CONTROL (K823566)Syva Co.1982-12-30
ADJ. WOODEN BOARD FOR WRITING (K823612)Fred Sammons, Inc.1982-12-30
FEP-RINGED GORE-TEX@ VASCULAR GRAFT (K821826)W. L. Gore & Associates, Inc.1982-12-29
5012 PARABOLIC STIMULATOR (K822923)Life-Tech Intl., Inc.1982-12-28
5011 GANZFELD STIMULATOR (K822922)Life-Tech Intl., Inc.1982-12-28
FEMALE EXTERNAL URINARY APPLIANCE (K823450)Diamed Division Ill. Tool Works, Inc.1982-12-28
CBM, CORE BUILD-UP MATERIAL (K823732)Scientific Pharmaceuticals, Inc.1982-12-28
ARM THROUGH FOR WHEELCHAIR BK-6459-01 & (K823636)Fred Sammons, Inc.1982-12-28
ROD W/HOOK TO PULL CLOTHES ON (K823604)Fred Sammons, Inc.1982-12-28
REAMER TYPE K ENDODONTIC (K823686)United Dental Mfg., Inc.1982-12-28
MINI-VAC DRAIN SYSTEM (K822902)Angus Medical Co.1982-12-28
FIBROSYSTEM (K823520)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-12-28
FILE TYPE K ENDODONTIC (K823684)United Dental Mfg., Inc.1982-12-28
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY (K823507)Hybritech, Inc.1982-12-28
HUMAN PLASMA CONTROL FOR CEA-ROCHE (K822219)Hoffmann-La Roche, Inc.1982-12-28
HARRIS HEMATOXYLIN (K823328)Accra Laboratories, Inc.1982-12-28
PARA 12 (K823498)Streck Laboratories, Inc.1982-12-28
ARTHROSCOPIC IRRIGATION SETS-2C4030/31 (K823496)Travenol Laboratories, S.A.1982-12-28
NEW FREEDOM THIN UNSCENTED MAXI PADS (K823241)Kimberly-Clark Corp.1982-12-28
FACTOR VIII RELATED ANTIGEN ROCKET EID (K823267)Helena Laboratories1982-12-28
CHAIR OR BED LEG EXTENDERS (K823634)Fred Sammons, Inc.1982-12-28
ALKPHOR SYSTEM (K823445)California Immuno Diagnostic, Inc.1982-12-28
HEMATOLOGY ANALYZER (K823344)Abbott Diagnostics1982-12-28
INTRAOCULAR LENS GUIDE (K823222)American Medical Optics1982-12-28
PEDIATRIC URINE COLLECTOR (K823411)Sage Products, Inc.1982-12-28
PAPINCOLABU STAIN EA-36/50/65 & OG-6 (K823329)Accra Laboratories, Inc.1982-12-28
HEARING AID UNITRON #UE4-H (K823669)Unitron Industries, Inc.1982-12-28
H. INFLUENZA B ANTISERA FOR CIE (K823348)Diagnostica, Inc.1982-12-28
PLASTIC BREAK RESISTANT MIRROR (K823606)Fred Sammons, Inc.1982-12-28
CORDIA CMV (K823123)Cordis Corp.1982-12-28
FORMED PLASTIC PANTY HOSE AID (K823603)Fred Sammons, Inc.1982-12-28
ULTRA CHEM BAN-UV #65080 & 65081 (K823472)Emd Chemicals, Inc.1982-12-28
PORTABLE ELECTRIC CAN OPENER (K823605)Fred Sammons, Inc.1982-12-28
MOXALACTAM (K822866)Lilly Research Laboratories1982-12-28
AMEDA HAND BREAST PUMP (K823591)Burditt & Calkins-Siemens-Elema1982-12-28
DADE ESR KIT (K823368)American Dade1982-12-28
CORNING 170 PH/BLOOD GAS ANALYZER (K823570)Corning Medical & Scientific1982-12-28
LEATHER & VELCRO SHOE FASTENER (K823628)Fred Sammons, Inc.1982-12-28
CARPET SWEEPER (K823607)Fred Sammons, Inc.1982-12-28
PORCELAIN ARTIFICIAL TEETH (K823744)Dentsply Intl.1982-12-28
LEATHER I VELCRO SHOE FASTENER REPAIR (K823627)Fred Sammons, Inc.1982-12-28
CANDIDA DETECTION SYSTEM (K823016)Ramco Laboratories, Inc.1982-12-28
5031 BRIGHT FLASH STIMULATOR (K822915)Life-Tech Intl., Inc.1982-12-28
OXYGEN CONCENTRATOR (K823524)C.R. Bard, Inc.1982-12-28
INFLATABLE HEAVY PLASTIC EXERCISER (K823623)Fred Sammons, Inc.1982-12-28
COULTER-COUNTER #S PLUS IV & LYSE S +D (K823355)Coulter Electronics, Inc.1982-12-28
CURAY ANTERIOR/POSTERIOR RESTORATIVE (K823510)Scientific Pharmaceuticals, Inc.1982-12-28
DILULAB 230 (K823522)Innovative Medical Systems, Inc.1982-12-28
IMMOPHASE TM HPL RADIOIMMUNOASSAY (K823292)Corning Medical & Scientific1982-12-28
IVFLO-HP & IVFIL-HP (K823690)Tri-Med, Inc.1982-12-28
REMOVAWELL PLATE LID (K823557)Dynatech Corp.1982-12-28
5010 VISUSTIM (K822919)Life-Tech Intl., Inc.1982-12-28
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Track 1982 automatically

Every clearance here is in the API, with alerts when new ones post.