Atlas FDA

1984

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

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RecordFirmDate
H.R. JAKOBI SURG. INSTRUMENTS #11 13/20 (K834180)Imm Enterprises , Ltd.1984-01-27
DRESSING CHANGE TRAYS (K833126)Intermed, Inc.1984-01-27
PAREMA K BAND NON-STERILE (K833867)Mark One Healthcare Products1984-01-27
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 (K833078)Cordis Corp.1984-01-27
SUN BED BY VERRE ET QUARTZ UVA-FRANCE (K833229)H & M Douglas Enterprises, Inc.1984-01-27
UV-A SUNTANNING EQUIPMENT-SILGMANN (K833511)Thomas G. Mason1984-01-27
SURE-CUT (K833467)Diverse Technologies, Inc.1984-01-27
ARTHROSCAN VIDEO SYSTEM (K834069)Concept, Inc.1984-01-27
YASARGIL FENESTRATED ANEURYSM CLIP & (K833652)Advanced Biosearch Assn.1984-01-27
JAKOBI SURG. INSTRUMENTS #12 40/41 (K834198)Imm Enterprises , Ltd.1984-01-27
ALPHA NON-INVASIVE BP CARDULE (K832764)Spacelabs, Inc.1984-01-27
UV-A SUN TANNING EQUIPMENT (K833527)Tan America Mfg.1984-01-27
ACETAMIDE AGAR SLANTS (K834509)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-01-27
PROPPER SERACULT (K834297)Propper Mfg. Co., Inc.1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 (K834184)Imm Enterprises , Ltd.1984-01-27
HOLTA-MED INFORMER PLAYBACK (K832354)Holta-Med1984-01-27
VASOSCAN (K833902)Sonicaid, Inc.1984-01-27
OP-CON SURG. INSTRUMENTS #11 (K834175)Imm Enterprises , Ltd.1984-01-27
POROCOAT SCHATZKER ACETABULUM (K833464)Depuy, Inc.1984-01-27
ADJUST-A-TEMP EXTRA FINE TIP (K840378)Suncoast Medical Manufacturers, Inc.1984-01-27
JAKOBI SURG. INSTRUMENTS #11 11/13/14 (K834195)Imm Enterprises , Ltd.1984-01-27
KOSMEDICO GMBH SUN LAMP (K833350)Kosmedico, Kosmetische & Medizinisch1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 (K834541)Imm Enterprises , Ltd.1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS 40/41 (K834176)Imm Enterprises , Ltd.1984-01-27
HYBRID PERIPHERAL DILATION CATHETER (K834220)American Edwards Laboratories1984-01-27
JAKOBI SURG. INSTRUMENTS #11 14/45 (K834185)Imm Enterprises , Ltd.1984-01-27
H.R. JAKOBI SURG. INSTRU. SECT. 48 (K834542)Imm Enterprises , Ltd.1984-01-27
TRIFLEX SURGEON'S GLOVES (K832448)Travenol Laboratories, S.A.1984-01-27
INSTRUMENT CABINET (K833882)Jedmed Instrument Co.1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #9 48 (K834179)Imm Enterprises , Ltd.1984-01-27
IURA UNIVERSAL WHEELCHAIR/STRETCHER- (K840125)Trade West, Inc.1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 (K834181)Imm Enterprises , Ltd.1984-01-27
SUNTANNING BOOTHS AND BEDS (K832794)Tan-N-Trim1984-01-27
MODIF. OF EMIT URINE BARBITURATE (K833577)Syva Co.1984-01-26
MODIF. OF EMIT URINE CANNABINOID (K833580)Syva Co.1984-01-26
AMBULASE XAM-15 XANAR SURG. LASER (K833325)Xanar, Inc.1984-01-26
RAYDEN MEDICAL MINI PULSE VOLUME RECORD (K833155)Burditt & Calkins-Siemens-Elema1984-01-26
MODIF. OF EMIT URINE BENZODIAZEPINE (K833578)Syva Co.1984-01-26
ROTARY VASCULAR KNIFE (K833547)Formedco, Inc.1984-01-26
P.T.I. DRESSING CHANGE TRAYS (K833758)Packaging Technologies, Inc.1984-01-26
MODIF. OF EMIT URINE AMPHETAMINE (K833579)Syva Co.1984-01-26
MODIF. OF EMIT URINE OPIATE ASSAY (K833581)Syva Co.1984-01-26
CRYSTALCONE FACE MASK-MED-W/HOOKRING (K834536)Warne Surgical Products, Ltd.1984-01-25
STERILE WET DRESSING PACK (K834532)W.G. Whitney Corp.1984-01-25
BURLINGTON ANTIMICROBIAL STOCKINEETTE (K833122)Balfour, Inc.1984-01-25
PREPACELL THIN NEEDLE ASPIRATION TRAY (K833719)Applied Medical Devices, Inc.1984-01-25
PUMP INFUSION WEARABLE INFUSION PUMP (K833966)Oximetrix, Inc.1984-01-25
PMT-OPTICA LINE (K831118)Pmt, Inc.1984-01-25
BURLINGTON STERILE ANTIMICROBIAL STOCK (K833121)Balfour, Inc.1984-01-25
LYMPHANGIOGRAPHY SET SPECIAL 30G (K834071)Hyperion, Inc.1984-01-25
DOPPLER PHANTOM FLOW CONTROL SYS (K834481)Radiation Measurements, Inc.1984-01-25
ACCURATE MEASUREMENT DEVICE KG-AMD (K833674)Sorensen Research1984-01-25
TISSUE MIMICKING ULTRASOUND PHANTOMS (K834482)Radiation Measurements, Inc.1984-01-25
FLO-GARD 8000 COMPUTER CONTROL INFUSI (K834154)Travenol Laboratories, S.A.1984-01-25
SELECTRODE SYSTEM (K832634)Bio-Stimu Trend Corp.1984-01-25
SKIN TECH. SURGI-STRIPS (K833258)Lee Tec Corp.1984-01-25
SINGLE-USE SURGICAL DRAPES (K833877)Procter & Gamble Mfg. Co.1984-01-25
AMER. V. MUELLER SURG. STAPLES ILA (K833698)American Heyer Schulte1984-01-25
STERILE SOLUTION WARMER (K833944)National Fabtronix, Inc.1984-01-25
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD (K832796)Syncor Intl. Corp.1984-01-24
C3 ANTISERUM CONTROL (K834604)Technicon Instruments Corp.1984-01-24
NATURELLE II & LITE II-N72-N74-L (K833774)Jeneric Ind.1984-01-24
EMIT QST PHENOBARBITAL ASSAY (K834216)Syva Co.1984-01-24
TECHNICON RA-1000 SYSTEM (K833992)Technicon Instruments Corp.1984-01-24
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB (K834294)Emd Chemicals, Inc.1984-01-24
NEUROTRON 100 (K833086)Neutro-Tronics1984-01-24
MICROLAB M DILUTER/DISPENSER (K833959)Syva Co.1984-01-24
PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (K833789)Medical & Scientific Designs, Inc.1984-01-24
FILAFEX ESTHETIC ORTHODINIC WIRE (K833788)Berkley and Co.1984-01-24
URINE THC CANNABINOIDS DIRECT RIA KIT (K833911)Immunalysis Corporation1984-01-24
THEOFAST TEST KIT FOR QUANTITATIVE THEO (K834244)Allergenetics1984-01-24
C4 ANTIGEN ANTIBODY CONTROL (K834605)Technicon Instruments Corp.1984-01-24
BEAR VENTI--VOICE (K834555)Bear Medical Systems, Inc.1984-01-24
IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (K833406)Corning Medical & Scientific1984-01-24
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN (K833402)Technicon Instruments Corp.1984-01-24
LYPHOCHEK THERAPEUTIC DRUG CONTROL (K833794)Bio-Rad1984-01-24
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT (K834052)Abbott Laboratories1984-01-24
COAT-A-COUNT NHS-PROLACTIN KIT AND (K833925)Diagnostic Products Corp.1984-01-24
LABORATORY DATA MGMT SYSTEM SDMS (K831838)Vickers America Medical Corp.1984-01-24
BIO-SCIENCE LABORATORIES T4 REAGENT (K834023)Biosan Laboratories, Inc.1984-01-24
K-FLEX OSTOMY POUCH (K840266)Coloplast A/S1984-01-23
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS (K834140)Intl. Diagnostic Technology1984-01-20
CHLORIDE REAGENT SET (K832438)Amresco, Inc.1984-01-20
RESPITRACE 300SC (K823780)Respitrace Corp.1984-01-20
DECUBITUS CARE ABSORBENT DRESSING (K832407)American Pharmaseal Div. Ahsc1984-01-19
ORTHO B-HCG SLIDE TEST FOR PREGNANCY (K833137)Ortho Diagnostic Systems, Inc.1984-01-18
PAEDIATRIC FACE MASK 1-3 W/WO RING (K834454)Warne Surgical Products, Ltd.1984-01-18
DURAZYME CPK (K833781)American Monitor Corp.1984-01-18
T4 RIA (K833850)Syncor Intl. Corp.1984-01-18
AUTO AIC ANALYZER SYSTEM (K833772)Helena Laboratories1984-01-18
ECG INTERFERENCE FILTER TF-03 (K832888)La Jolla Technology, Inc.1984-01-18
ACID BASE LABORATORY ABL4 (K833696)Radiometer America, Inc.1984-01-18
YASARGIL STANDARD ANEURYSM CLIP & (K833650)Advanced Biosearch Assn.1984-01-18
RESCUE MASK (K834250)Rondex Products, Inc.1984-01-18
TANDEM R-TOTAL B-GCG KIT (K833194)Hybritech, Inc.1984-01-18
KODAK EKTACHEM 700 ANALYZER (K833833)Eastman Kodak Company1984-01-17
LOEFFLER MEDIUM TUBE (K834426)Otisville Biotech, Inc.1984-01-17
TECHMEDICA-HEWSON SHOULDER CLEAT (K834411)Techmedica, Inc.1984-01-17
CDC ANAEROBE BLOOD AGAR PLATE (K834418)Otisville Biotech, Inc.1984-01-17
MED-OPEDIC SLEEP SYSTEM (K834344)Bemco Mattress Co.1984-01-17
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