Atlas FDA

1985

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

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RecordFirmDate
SURGICAL BLADES (K854620)Niraj Industries1985-12-17
SURGICAL INSTRUMENT TRAY (K854746)Zbi, Inc.1985-12-17
AMERICAN STERILE MAYO STAND TRAY (K854759)American Hospital Supply Corp.1985-12-17
MODIFIED MYDRIATIC SPECTACLE (K854140)La Rue Optical1985-12-17
MALIS MICRO BIPOLAR COAGULATOR (K854592)Valley Forge Scientific Corp.1985-12-17
TIP OFF FORCEPS (K854541)Keller Instruments, Inc.1985-12-17
ZIMMON BILIARY STENT SET (K851962)Wilson-Cook Medical, Inc.1985-12-17
THE CALIFORNIA SPLINT (K854752)Intl. Medication Systems, Ltd.1985-12-17
PVL-4.8-200 BALLOON STONE EXTRACTOR (K851954)Wilson-Cook Medical, Inc.1985-12-17
X-RAY DETECTABLE COTTON BALLS (K854714)American Silk Sutures, Inc.1985-12-17
HYPODERMIC NEEDLE AND STYLET (K854579)Berkley and Co.1985-12-17
FANA 60 (K854314)American Bio-Reagents, Inc.1985-12-16
ALL-IN-ONE HARD CONTACT LENS SOLUTION (K853807)Maurry Biological Co.1985-12-16
HARD CONTACT LENS SOAKING SOLUTION (K853811)Maurry Biological Co.1985-12-16
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED (K854045)American Bentley1985-12-16
ROOT CANAL FILLING RESIN (K854253)Dentsply Intl.1985-12-16
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (K854440)Keeler Instruments, Inc.1985-12-16
SPINAL STABILIZING UNIT (K851864)Counterstress Products, Inc.1985-12-16
LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM (K852365)Link America, Inc.1985-12-16
PUPILSCAN (K854169)Fairville Medical Optics, Inc.1985-12-16
WETTING SOLUTION FOR HARD CONTACT LENSES (K853810)Maurry Biological Co.1985-12-16
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH (K854479)Nipro Company, Ltd.1985-12-16
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT (K853697)Biostar Medical Products, Inc.1985-12-16
HD-SECURA HEMADIALYSIS MACHINE (K854367)Organon Teknika Corp.1985-12-16
STORZ IAS DISPOSABLE PACK (K853430)Storz Instrument Co.1985-12-16
DSL PROGESTERONE RIA (DSL #3400) (K854649)Diagnostic Systems Laboratories, Inc.1985-12-13
THE GRONINGEN VOICE PROSTHESIS (K853940)Hood Laboratories1985-12-13
IN-HOME VISION MONITORING KIT (K854047)Rich-Larky Company, Inc.1985-12-13
700-123 EYE SHADE (K853043)Health Saver Products1985-12-13
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE (K854724)Lifetrac, Inc.1985-12-13
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 (K854776)Carrom Healthcare, Inc.1985-12-13
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650)Diagnostic Systems Laboratories, Inc.1985-12-13
HOLLOW FIBER DIALYZER (K854586)Travenol Laboratories, S.A.1985-12-13
HESSBURG LIGHT GUARD (K853035)Visitec Co.1985-12-13
PORTASPIR II (K851560)Roseburg SA1985-12-13
RAICHEM CO2 REAGENT (K854544)Reagents Applications, Inc.1985-12-13
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH (K854580)Coloplast A/S1985-12-13
RESNICK EMITTER, ARTIFICIAL LARYNX (K854158)Dynamed Audio, Inc.1985-12-13
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 (K853961)Visitec Co.1985-12-13
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 (K854309)Gambro, Inc.1985-12-13
KEELER AMOILS SURGICAL ASTIGOMETER (K854256)Keeler Instruments, Inc.1985-12-13
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) (K853729)Ryder Intl. Corp.1985-12-13
KESTREL CONTACT LENS STORAGE CASE(NORYL) (K853728)Ryder Intl. Corp.1985-12-13
CLIRANS TAF HOLLOW FIBER DIALYZER (K854280)Terumo Medical Corp.1985-12-13
PARAAMAX CHLORIDE DETERMINATION BY ISE (K854651)American Dade1985-12-13
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM (K854330)Par Technology Park1985-12-13
L.E.D. GOGGLES, MODEL 580-LEDGOG (K852533)Bio-Logic Systems Corp.1985-12-12
ANTI-EPSTEIN-BARR VIRUS KIT (K842662)Amico Lab, Inc.1985-12-12
NIFA NON INVASIVE FLUTTER ASSEMBLY (K844853)Emergency Management Products, Inc.1985-12-12
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (K853987)Pall Biomedical Products Co.1985-12-11
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT (K854483)Kallestad Laboratories, Inc.1985-12-11
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT (K840367)Smec, Inc.1985-12-11
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL (K853950)American Bentley1985-12-11
CARDIORATER CR 51 (K853673)Cardiac Recorders, Ltd.1985-12-11
DELTA-LITE CASTING RESIN (K854554)Johnson & Johnson Professionals, Inc.1985-12-11
EMERSON MODEL 3MV-OAA ALARM MODULE (K854799)J. H. Emerson Co.1985-12-11
MGA 2000 GAS ANALYSER (K854076)Airspec , Ltd.1985-12-11
MA-400 EMB FEEDBACK DEVICE (K853806)Spectral Data Systems1985-12-10
CHURCHILL-HE VENTED IV SET (K854636)Churchill Corp.1985-12-10
CHURCHILL-HS SUSPENDED NON-VENTED IV SET (K854630)Churchill Corp.1985-12-10
MODEL 210 INFUSION PUMP (K854073)Avi, Inc.1985-12-10
MODEL 200 INFUSION PUMP (K854074)Avi, Inc.1985-12-10
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (K854232)American Pharmaseal Div. Ahsc1985-12-10
EASY EYES TM LENS CARRYING CASE (K853870)Applied Laboratories, Inc.1985-12-10
MEDAJET XL - JET INJECTOR (K850754)Mada Medical Products, Inc.1985-12-10
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (K854735)Portable Medical Laboratories, Inc.1985-12-10
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT (K853930)Quantimetrix Corp.1985-12-10
CHURCHILL-HS SUSPENDED VENTED IV SET (K854627)Churchill Corp.1985-12-10
STERILE SALINE SOLUTION (K854155)I M, Inc.1985-12-10
CHURCHILL-H EXTENSION TUBE (K854629)Churchill Corp.1985-12-10
SUPPORT ARM (K854162)Healthmate, Inc.1985-12-09
PERIPHERAL NERVE STIMULATOR MODEL A400 (K852962)Fisher & Paykel Allied Products , Ltd.1985-12-09
RT3600(115V) RT3600(220/240V) (K853249)General Electric Co.1985-12-09
FLUID MANAGEMENT SYSTEM (K852645)Haemonetics Corp.1985-12-09
PULMO-AIDE MODEL 5610D (K854520)The Devilbiss Co.1985-12-09
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM (K854338)Kirschner Medical Corp.1985-12-09
TITANIUIM BONE SCREW (K853869)George Tiemann & Co.1985-12-09
MEDILOG M6 (K852892)Oxford Medilog, Inc.1985-12-09
ATRIUM PLASMA TFE SYNTHETIC ARTERY (K853725)Atrium Medical Corp.1985-12-09
KIRSCHNER SPINAL PRODUCT SYSTEM (K854524)Kirschner Medical Corp.1985-12-09
MILLAR/GALANTE PRECOATED TOTAL KNEE (K853661)Zimmer, Inc.1985-12-09
TRICON UNICOMPARTMENTAL KNEE SYSTEM (K854325)Richards Medical Co., Inc.1985-12-09
DISPOSABLE SYRINGES & NEEDLES (K854563)Medelec Intl. Corp.1985-12-09
LIFEPAK 8 MODIFICATION (K853732)Physio-Control Corp.1985-12-09
MODEL 804 (TENS) (K853442)Oriental Medical Supplies, Inc.1985-12-09
REGULATOR-INHALATOR SYSTEM (K853971)Stephenson Industries, Inc.1985-12-09
MURPHY ADJUSTABLE SPLINT (K854270)Comfortex, Inc.1985-12-09
NEURO PULSE II (K853836)Nagata Engineering Co.1985-12-09
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 (K853072)Camino Laboratories, Inc.1985-12-09
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD (K854069)Intermedics, Inc.1985-12-09
LIFE WATCH RESPIRATORY MONITOR (K853840)The Perkin-Elmer Corp.1985-12-09
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 (K853791)Norton Performance Plastics Corp.1985-12-09
AUTO MASH (K854604)Dynatech Corp.1985-12-06
EMPI, NMS/SUE CUTANEOUS ELECTRODE (K854513)Empi1985-12-06
AMIZYME-HSV TYPES 1 & 2 TEST KITS (K842531)Amico Lab, Inc.1985-12-06
ANTI-CYTOMEGALOVIRUS KIT (K842661)Amico Lab, Inc.1985-12-06
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST (K853738)Ortho Diagnostic Systems, Inc.1985-12-06
DEDO SUCTION CANNULA (K854005)Dedo Manufacturer, Inc.1985-12-06
MULTI MASH 2000 (K854603)Dynatech Corp.1985-12-06
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (K842663)Amico Lab, Inc.1985-12-06
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Track 1985 automatically

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