Atlas FDA

1984

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

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RecordFirmDate
SURGEONS CHOICE PI VASCULAR STAPLING (K843399)Surgeons Choice, Inc.1984-11-05
AZTECH INDUSTRIES SUNTANNING BED AZ100 (K844039)Aztech Industries, Inc.1984-11-05
GILL'S IRRIGATOR/ASPIRATOR NEEDLE (K843925)Concept, Inc.1984-11-05
SNYDER HEMOVAC WOUND DRAINAGE DEVICES (K843906)Snyder Laboratories, Inc.1984-11-05
AMER. EDWARDS LAB FLEXISCOPE (K842410)American Edwards Laboratories1984-11-05
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA (K842511)Johnson & Johnson Professionals, Inc.1984-11-05
HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHY (K842691)Health Technology Services1984-11-05
SUSPENSION 7 (K843985)Cgr Medical Corp.1984-11-05
ROCHE REAGENT FOR AST (K843109)Roche Diagnostic Systems, Inc.1984-11-05
DISPOSABLE LATEX BANDAGE (K842301)Inmed Corp.1984-11-05
DERMIZIP SKIN CLOSURE DEVICE (K844072)Kells Medical, Inc.1984-11-05
TRENDS LANCET (K843882)Orange Medical Instruments, Inc.1984-11-05
SUTURE TRAY (K843525)Pro-Lab, Inc.1984-11-05
I.V. TEAMATE (K842479)Medical Delivery Systems1984-11-02
TEMPTREND PEDS AXILLARY TEMP. INDICATOR (K841913)Biosynergy, Inc.1984-11-02
HDL PRECIPATATING REAGENT SET (K843894)Livonia Diagnostics, Inc.1984-11-02
ABBOTT HTSH EIA DIAGNOSTIC KIT (K843540)Abbott Laboratories1984-11-02
VITAJET JET INSULIN INJECTION DEVICE (K843784)Vitajet Industriae Comercioltda.1984-11-02
PHARMACIA B2-MICRO RIA (K842772)Pharmacia, Inc.1984-11-01
IN THE CANAL HEARING AID RC, REDICANAL (K843921)Omni Hearing Systems1984-11-01
APTA-BRONCHOSCREEN (K843852)Erich Jaeger, Inc.1984-11-01
COLORZYME NDNA TEST SYSTEM (K843225)Immuno Concepts, Inc.1984-11-01
TERM GUARD 5000 UTERINE ACTIVITY (K843011)Tokos Medical Corp.1984-11-01
AW TEST (K843848)Erich Jaeger, Inc.1984-11-01
DNA STAT TEST KIT (K843904)Whittaker Bioproducts, Inc.1984-11-01
SUN-ONE (K842048)Ensun Medical Products, Inc.1984-11-01
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE (K843962)R&D Systems, Inc.1984-11-01
PERICARDIAL PATCH (K833763)American Edwards Laboratories1984-11-01
AUTOFLOUR III SYSTEM (K841984)Tech America Diagnostics1984-11-01
MICROPROCESSOR 7200A VENTILATOR (K843424)Puritan Bennett Corp.1984-11-01
INTERMEDICS SYRINGE PUMP 710-02 (K843548)Intermedics, Inc.1984-10-31
AUTOMATIC MULTICLIP DISPOS. LIGATING (K843336)Davis & Geck, Inc.1984-10-31
ARTAP ARTERIAL BLOOD SAMPLING DEVICE (K843360)Analytical Products, Inc.1984-10-31
MSI SURGI-GRADE SUTURE TRAY (K843564)Medical Sterilization, Inc.1984-10-31
PHARMA-PLAST INSULIN SYRINGE (K843473)Zimmar Consulting , Ltd.1984-10-31
PHARMA-PLAST SYRINGE WITH NEEDLE (K843472)Zimmar Consulting , Ltd.1984-10-31
DRAPE SURGICAL UTILITY DRAPE STERILE (K843496)Busse Hospital Disposables, Inc.1984-10-31
ONO/CO-TWO (TM) SYSTEMS (K844014)Micro-Bio-Logics1984-10-31
MEDICAL TAPE (K840446)Lectec Corp.1984-10-31
ULTRAXLONE ECL-01-1000 CELL LINE (K843577)Earl-Clay Laboratories, Inc.1984-10-31
CANNULA (K843187)ETHICON, Inc.1984-10-31
PHARMA-PLAST SYRINGE (K843471)Zimmar Consulting , Ltd.1984-10-31
SKIN TECH. ISOTEX 86L (K840609)Lectec Corp.1984-10-31
ETHANOL CONTROLS LOW & HIGH E5133/E5258 (K843872)Sigma Chemical Co.1984-10-31
PYRO-TIP (K841591)Suncoast Medical Manufacturers, Inc.1984-10-31
FIRST AID BANDAGE (K840951)Gainor Medical1984-10-31
UVA SUNTANNING UNITS VARIOUS MODELS (K843306)Topsolo Sun Systems1984-10-31
SURGICAL KNIVES & PROBES (K843497)Eder Instrument Co, Inc.1984-10-31
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (K843613)Immuno-Products Industries1984-10-31
AVI GUARDIAN 400 INFUSION PUMP (K843616)Avi, Inc.1984-10-31
STREP ID TRIPLATE (K844019)Remel Co.1984-10-31
ZINC OXIDE TAPE (K840950)Gainor Medical1984-10-31
WILCOX ROD & PLATE BENDER (K840547)Downs Surgical , Ltd.1984-10-31
TAL-CLIP (K843816)Talboy, Inc.1984-10-31
SIGMA SUDAN BLACK REAGENT 380-1 (K843684)Sigma Chemical Co.1984-10-31
AVI GUARDIAN MICRO 410 INFUSION PUMP (K843615)Avi, Inc.1984-10-31
MCGHAN TISSUE EXPANDER (K843704)Mcghan Medical Corp.1984-10-31
CONCEPT C-VAC (K842710)Concept, Inc.1984-10-31
ARTHROSCOPY LEG HOLDER (K843499)Eder Instrument Co, Inc.1984-10-31
AO-10 AUTOMATED OSMOMETER (K843997)bioMerieux, Inc.1984-10-31
ND-YAG LASER 8000 NEUROSURGERY APPLICA (K842703)Cooper Lasersonics, Inc.1984-10-31
JACOBS HIGH VACUUM SUCTION UNIT 05-2570 (K843693)J. Sklar Mfg. Co., Inc.1984-10-31
MEDICAL ADHESIVE FOAM TAPE (K840448)Lectec Corp.1984-10-31
AUTO SUTURE POLY GIA SURGICAL STAPLER (K843603)United States Surgical, A Division of Tyco Healthc1984-10-31
PHARMA-PLAST SINGLE USE OVERSHOES (K843475)Zimmar Consulting , Ltd.1984-10-31
RAICHEM X-HBDH REAGENT (K843774)Reagents Applications, Inc.1984-10-31
ULTRACLONE ECL-01-1100 (K843579)Earl-Clay Laboratories, Inc.1984-10-31
ULTRACLONE ECL-01-2100 CELL LINE (K843578)Earl-Clay Laboratories, Inc.1984-10-31
FLU VEN I.V. SET 0153-C PERMA-SET (K843692)Venusa , Ltd.1984-10-31
O.B. BASIN SET (K843982)Pro-Lab, Inc.1984-10-31
NISONSON WIRE & DRILL GUIDE SYS (K843348)Stryker Corp.1984-10-31
SKIN CLOSURE (K840945)Gainor Medical1984-10-31
PARATHYROID HORMONE C-TERMINAL RIA KIT (K843871)Diagnostic Products Corp.1984-10-30
PHOTOMETER 90IYS (K843668)Institute Virion , Ltd.1984-10-30
LINEAR ENZYMATIC URIC ACID SYSTEM (K843938)Simmler, Inc.1984-10-30
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (K843930)Euro-Diagnostics BV1984-10-30
BETA QUIK V (K843795)Pacific Biotech, Inc.1984-10-30
IMPEDANCE/8200 MONITOR-MODEL 8300 (K840358)Aequitron Medical, Inc.1984-10-30
DETECT-A-STREP (K843590)Antibodies, Inc.1984-10-30
SPOTTEST LOEFFLER METHYLENE BLUE STAIN (K843919)Difco Laboratories, Inc.1984-10-30
ANTI-SCHISTOSOMA SPECIES KIT (K842660)Amico Lab, Inc.1984-10-30
SERVO MED NYSTAGMOGRAPH NG-1 (K843004)Servo Med, Inc.1984-10-30
EMA LIV CENERA DENTAL CEMENT (K842995)Int'L Corp.1984-10-30
SIGMA PERIODIC ACID-SCHIFF STAIN 395 (K843752)Sigma Chemical Co.1984-10-30
PYR BROTH (K843987)Remel Co.1984-10-30
PARATHYROID HORMONE MID-MOLECULE RIA-KIT (K843870)Diagnostic Products Corp.1984-10-30
TOTAL CALCIUM REAGENT SET (K843895)Livonia Diagnostics, Inc.1984-10-30
STRAIGHT AND BUBBLE OXYGEN TUBING (K844083)Hudson Extrusions, Inc.1984-10-30
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K843534)Immunalysis Corporation1984-10-30
COBAS FP TDM CONTROLS (K843913)Roche Diagnostic Systems, Inc.1984-10-30
MUSE-DP (K840932)Marquette Electronics, Inc.1984-10-30
RETIC-SET (K843619)R&D Systems, Inc.1984-10-30
FOCUS URIC ACID (K844011)Abbott Laboratories1984-10-30
POLYVINYL CHLORIDE CANNULAS (K844084)Hudson Extrusions, Inc.1984-10-30
SCOTT SELECTICULT-HSV ISOLATION & (K841680)Scott Laboratories, Inc.1984-10-30
MAGNESIUM REAGENT SET (K843893)Livonia Diagnostics, Inc.1984-10-30
TDX REA CREATININE (K843916)Abbott Laboratories1984-10-30
URIC ACID REAGENT SET (K844075)Livonia Diagnostics, Inc.1984-10-30
CREATININE REAGENT SET (K844024)Livonia Diagnostics, Inc.1984-10-30
HUMAN SERUM ANTICONVULSANT DRUG CONTROL (K843818)Quantimetrix Corp.1984-10-30
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Every clearance here is in the API, with alerts when new ones post.