Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY (K850412)Warner-Lambert Co.1985-05-08
IMED GRAVISET INTRAVASCULAR ADMIN. SET (K851360)Imed Corp.1985-05-08
SANDARE IRON-BINDING CAPACITY PROCEDURE (K851395)Sandare Chemical Co., Inc.1985-05-07
SUNTANNING EQUIPMENT (K851532)Oakport Intl., Inc.1985-05-07
ESCOTEK-EST 204 MULTI STIM (K844390)Nor-Am Patient Care Products, Inc.1985-05-07
ADJUSTABLE TREATMENT TABLES (K851690)I-Rep, Inc.1985-05-07
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM (K851361)Amersham Corp.1985-05-07
ESCOTEK EST 220 INTERFERENCE THERAPY UNIT (K844388)Nor-Am Patient Care Products, Inc.1985-05-07
SINUS AC-POWERED MUSCLE STIMULATOR (K850453)Zimmer Elektromedizin GmbH1985-05-07
PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV (K850888)Creative Care Systems, Inc.1985-05-07
SMART ALEX II MULTI-FILTER PHOTOMETER (K850993)Awareness Technology, Inc.1985-05-07
VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 (K851474)Vygon Corp.1985-05-07
ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI (K844389)Nor-Am Patient Care Products, Inc.1985-05-07
GELIPERM ABSORBIND GRANULATED GEL (K850819)Geistlich-Pharma1985-05-07
ESCOTEK-EST 221 VACUUM UNIT (K844387)Nor-Am Patient Care Products, Inc.1985-05-07
QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU (K851017)Quest Medical, Inc.1985-05-07
CORRECT FLO (K851299)Norton Performance Plastics Corp.1985-05-07
VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW (K851480)Vygon Corp.1985-05-07
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183 (K851478)Vygon Corp.1985-05-07
HYPAFIX POST OPERATIVE DRESSING (K850282)Smith & Nephew, Inc.1985-05-07
THE I.V. BAG (K844664)Kabivitrum, Inc.1985-05-06
QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM (K850455)Xre Corp.1985-05-06
CODMAN DISPOSABLE BIPOLAR CARD (K851487)Codman & Shurtleff, Inc.1985-05-03
STERILE DISPOSABLE PN DRAPE SYSTEM (K850912)Brant-Wald Surgicals, Inc.1985-05-03
DERMA PREP (K851612)Mowbray Co., Inc.1985-05-03
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER (K851443)Micro-Aire Surgical Instruments, Inc.1985-05-03
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 (K851475)Vygon Corp.1985-05-03
VYGON EXCHANGE TRANSFUSION TRAY 275.00 (K851477)Vygon Corp.1985-05-03
SHOULDER TRACTION KIT (K851656)Chattanooga Group, Inc.1985-05-03
UNIVERSAL COMPUTER INTERFACE SYSTEM (K851706)Vacumetrics, Inc.1985-05-03
PM CEMENTLESS SCREW-IN ACETABULAR CUP (K850773)Advanced Biosearch Assn.1985-05-02
COLUMBIZ CNA AGAR W/5% SHEEP BLOOD (K851580)Preferred Micro-Media1985-05-02
QUICKIE WHEELCHAIRS (K850536)Motion Designs, Inc.1985-05-02
TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO (K850864)Paco Research Corp.1985-05-02
CO-AX VENTILATOR CIRCUIT (K850600)Nova-Ventrx1985-05-02
GN BROTH (K851582)Preferred Micro-Media1985-05-02
COBAS MIRA (K851172)Roche Diagnostic Systems, Inc.1985-05-02
SYSTEM 8000 CELL COUNTER (K850386)Baker Instructions Corp.1985-05-02
PATHO DX LATEX AGGLUTINATION STREP B KIT (K845022)Diagnostic Products Corp.1985-05-02
HEKTOEN ENTERIC AGAR (K851583)Preferred Micro-Media1985-05-02
DERMATOPHYTE TEST MEDIUM (K851581)Preferred Micro-Media1985-05-02
ABCO SUTURE REMOVAL KITS-METAL & PLASTIC FORCEPS (K851313)Abco Dealers, Inc.1985-05-01
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (K851264)American Medical Optics1985-05-01
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E (K850361)Synectics-Dantec1985-05-01
ESCOTEK EST TRAC 401 (K844385)Nor-Am Patient Care Products, Inc.1985-05-01
KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES (K850631)Kirschner Medical Corp.1985-05-01
SUN MEDICAL LAMINARIA CERVICAL DILATOR (K845006)Sun Medical, Inc.1985-05-01
ESCOTEK-EST 301A ULTRA-SONIC UNIT (K844386)Nor-Am Patient Care Products, Inc.1985-05-01
76 ELW BITE CHECKER SILICONE (K851469)G-C Intl. Corp.1985-05-01
GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK (K850957)Warner-Lambert Co.1985-05-01
PHILIPS UV-A SOLARIUM TYPE HP 3150 (K851534)Philips Int'L B.V.1985-05-01
HI-LO TILT TABLE 625 (K850377)Tri W-G, Inc.1985-05-01
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE (K850332)Richards Medical Co., Inc.1985-05-01
DRESSING CHANGE KIT (K850887)Creative Care Systems, Inc.1985-05-01
ABCO INSTRUMENT PACKS & TRAYS (K851315)Abco Dealers, Inc.1985-05-01
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) (K844969)Cordis Corp.1985-05-01
I.V. START KIT (K851226)Perry, Div.1985-05-01
PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP (K851533)Philips Int'L B.V.1985-05-01
76 EMA LINING CEMENT (K851468)G-C Intl. Corp.1985-05-01
FETAL TELEMETRY SYSTEM (K844724)Advantage Medical Systems, Inc.1985-05-01
DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (K850255)Dow Corning Corp. Healthcare Industries Materials1985-05-01
PREGNA-ZYME (K850992)Armkel, LLC1985-05-01
ABDOMINAL PRESSURE CONTROL VALVE (K844829)L.A.S.E.R., Inc.1985-05-01
ZIMMER THREADED ACETABULAR CUP (K850766)Zimmer, Inc.1985-05-01
ABCO DRAPES/TOWELS (K851314)Abco Dealers, Inc.1985-05-01
EMIT 700 CANNABINOID 20 ASSAY (K851373)Syva Co.1985-05-01
ABCO ISOLATION MASKS (K851312)Abco Dealers, Inc.1985-05-01
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (K851263)American Medical Optics1985-05-01
PHILIPS UV-A SOLARIUM TYPE HP 3140 (K851535)Philips Int'L B.V.1985-05-01
PHILIPS UV-A SOLARIUM TYPE HP 3141 (K851536)Philips Int'L B.V.1985-05-01
SURGICRAFT COPELAND DISPOSABLE (K844608)A.W. Showell (Surgicraft) , Ltd.1985-05-01
SURGICAL CAP CALOT (K851558)Roseburg SA1985-04-30
MEDIPART XENON BREATHING KIT MP-02XM-I (K850367)Medipart Jerry Alexander1985-04-30
THAYER MARTIN AGAR & MODIFIED THAYER AGAR (K851587)Preferred Micro-Media1985-04-30
TDX ANALYZER W/NEPHELOMETRY CAROUSEL (K851253)Abbott Laboratories1985-04-30
AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA (K851262)American Medical Optics1985-04-30
FIAX TOXO-M ANTIBODIES TEST KIT (K850591)Intl. Diagnostic Technology1985-04-30
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE (K851589)Preferred Micro-Media1985-04-30
ENTERNAL FEEDING PUMP BATTERY OPER. (K841104)Fresenius USA, Inc.1985-04-30
MEDIPART XENON BREATHING KIT MP-OIXM-I (K850366)Medipart Jerry Alexander1985-04-30
MACCONKEY AGAR (K851586)Preferred Micro-Media1985-04-30
OVERSHOES (SURCHAUSSURES (K851554)Roseburg SA1985-04-30
K-SOL (K844249)Cilco, Inc.1985-04-30
TURQUOISE (K851559)Roseburg SA1985-04-30
DEMAND OXYGEN SAUER DOS2 MODEL 10 (K851235)Applied Membrane Technology, Inc.1985-04-30
ANGIOTEC SC 1221 SCAN CONVERTER (K850330)Angiotec1985-04-30
LEVINE EMB AGAR (K851584)Preferred Micro-Media1985-04-30
MANNITOL SALT AGAR (K851585)Preferred Micro-Media1985-04-30
MYCOLOGY AGAR W/ANTIBOTICS (K851590)Preferred Micro-Media1985-04-30
CHOCOLATE AGAR (K851588)Preferred Micro-Media1985-04-30
OP-FACE MASK(MASQUE DE CHIRUGIE) (K851556)Roseburg SA1985-04-30
QUADRA TITER MICRO PLATES (K850725)Microtech Medical Systems, Inc.1985-04-30
SANDARE IRON PROCEDURE (K851394)Sandare Chemical Co., Inc.1985-04-30
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL (K851202)Gilford1985-04-29
DOSI FLOW (K851058)Leventon, S.A.1985-04-29
PROLACTIN SYSTEM BY RIA (K851330)American Bioclinical, Inc.1985-04-29
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-2050 (K850477)Unisonic Products Corp.1985-04-29
MUELLER HINTON SENSITIVITY PLATE (K851518)Culture Kits, Inc.1985-04-29
ARCEE DENTAL POST (K851038)Arcee Dental Products Co.1985-04-29
INTRACARDIAC SUMP 12010 (K850385)Dlp, Inc.1985-04-29
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Track 1985 automatically

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