Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

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RecordFirmDate
THE MIDVIEW-MEDCON'S DICOM VIEWER (K971181)Medcon , Ltd.1997-07-29
LASER PERIPHERALS HOLMIUM BARE FIBERS (K972272)Laser Peripherals, LLC1997-07-29
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K972177)Absolute Synthetic Technologies Malaysia Sdn. Bhd.1997-07-29
CARDIAC STATUS CONTROLS/TROPONIN I (K972687)Spectral Diagnostics, Inc.1997-07-28
FIRST MEDIC PULSE OXIMETRY MODULE (K955890)Colorado Medtech, Inc.1997-07-28
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES (K972291)Allegiance Healthcare Corp.1997-07-28
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (K972528)Dyna Corp.1997-07-28
A-V IMPULSE SYSTEM MODEL 6060 (K964425)Powell,Goldstein,Frazer & Murphy1997-07-28
POWDER-FREE PATIENT EXAMINATION GLOVES (K971949)Tekmedic (M) Sdn Bhd1997-07-28
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) (K971744)Berkley Medical Resources, Inc.1997-07-28
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER (K971695)Fisher & Paykel Electronics , Ltd.1997-07-28
FOSFOMYCIN, 200 MG, SENSI-DISC (K972098)Becton Dickinson Microbiology Systems1997-07-28
TINAQUANT MYOGLOBIN ASSAY (K972513)Boehringer Mannheim Corp.1997-07-28
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 (K963777)Stephenson Industries, Inc.1997-07-28
MM-1 MOVEMENT MONITOR (K971318)Axon Instruments, Inc.1997-07-28
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP (K971604)Alexander Mfg. Co.1997-07-28
CARD GUARD, MODEL CG-7100 (K964836)Card Guard Scientific Survival , Ltd.1997-07-28
ANNULOFLO SYSTEM (K970375)Carbomedics, Inc.1997-07-25
RAMY PISTON SYRINGE (K971664)Alshifa Medical Syringes Mfg. Co., Ltd.1997-07-25
SUCTION INSTRUMENTATION (K972074)Walter Lorenz Surgical, Inc.1997-07-25
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III (K972144)Sigma Diagnostics, Inc.1997-07-25
IMMULITE FREE T4 (2-STEP) (K971792)Diagnostic Products Corp.1997-07-25
VIBRA-SURGE SYSTEM MODEL VS2120 (K971533)Sonics & Materials, Inc.1997-07-25
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (K972123)Smith1997-07-25
POCKET COUNT OR SAFETCOUNT (K972302)Sage Products, Inc.1997-07-25
CARDIAC STATUS CONTROLS (K972408)Spectral Diagnostics, Inc.1997-07-25
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT (K971660)Olympus America, Inc.1997-07-25
VON WILLEBRAND REAGENT (K972116)Behring Diagnostics, Inc.1997-07-25
D'ARC EYE CARE SUNGLASSES (K972490)M & R Dist.1997-07-25
PERCUTANEOUS VENOUS INTRODUCER 10264 (K965167)Medamicus, Inc.1997-07-25
ELECSYS PSA ASSAY (K964351)Boehringer Mannheim Corp.1997-07-25
PROTEGE LIQUID OXYGEN SYSTEM (K971545)Healthdyne Technologies, Inc.1997-07-25
ARROW-TREROTOLA PTD CATHETER (K970080)Arrow Intl., Inc.1997-07-25
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION (K972172)R&D Systems, Inc.1997-07-24
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST (K971825)Randox Laboratories, Ltd.1997-07-24
CYBERREN (K970989)Cybernius Medical , Ltd.1997-07-24
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT (K971742)Depuy, Inc.1997-07-24
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM (K972348)Hewlett-Packard Co.1997-07-24
DENTALIS KEZ ENDODONITC SEALER (K971642)Neodental Chemical Products Co., Ltd.1997-07-24
CHOLESTECH BUN/CREATININE TEST SYSTEM (K972012)Cholestech Corp.1997-07-24
CYTOLOGY BRUSH (K971849)Team Technologies, Inc.1997-07-24
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE (K971511)Radionics, Inc.1997-07-24
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION (K972170)R&D Systems, Inc.1997-07-24
CEDIA DIGOXIN CALIBRATORS (K972433)Boehringer Mannheim Corp.1997-07-24
COLORMATE III (K964590)Chromatics Color Sciences Intl., Inc.1997-07-24
AMS COAGULOOP RESECTION ELECTRODE (K971512)American Medical Systems, Inc.1997-07-24
PATTISON ESOPHAGEAL DILATOR (K971615)Tri-Med Specialties, Inc.1997-07-24
IMPLEX CONTINUUM POROUS PATELLAR (K971789)Implex Corp.1997-07-24
RAMY INTEGRATED NEEDLE SYRINGE (K972452)Alshifa Medical Syringes Mfg. Co., Ltd.1997-07-24
REACH ANTIBACTERIAL TOOTHBRUSH (K971589)Personal Products Co.1997-07-24
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES (K971518)KARL STORZ Endoscopy-America, Inc.1997-07-24
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS (K971607)Boston Scientific Corp1997-07-24
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT (K971180)C.R. Bard, Inc.1997-07-24
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. (K972338)Geriatric Products, Inc.1997-07-24
CORELIFE (K964230)Core Healthcare , Ltd.1997-07-24
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS (K971668)GE Medical Systems1997-07-24
POSEIDON CARDIAC MONITORING SYSTEM (PCMS) (K964408)Instromedix, Inc.1997-07-23
B SMART MODEL 1 (K961817)Koven Technology, Inc.1997-07-23
CAMOUFLAGE CUFF SAVERS (K963987)N.A. Braggs Medical, Inc.1997-07-23
MYRINGOTOMY TUBE - BOBBIN WITH TAB (K972400)Mednet Locator, Inc.1997-07-23
MIRACLE-EAR DIGITAL BTE (K972344)Miracle-Ear, Inc.1997-07-23
ULTIMA TPS CEMENTED STEM (K965198)Johnson & Johnson International1997-07-23
STREP A OIA MAX (K962060)Biostar, Inc.1997-07-23
FREERIDER, MODEL FR510-F (K971387)Freerider USA, Inc.1997-07-23
FREERIDER, MODEL FR168-4 (K971388)Freerider USA, Inc.1997-07-23
BETTER HEARING, INC. MODEL L-1 HEARING AID (K971298)Better Hearing, Inc.1997-07-23
MICRO-SEAL ACETABULAR SYSTEM (K971718)Whiteside Biomechanics, Inc.1997-07-23
TARGET 2 VERSION 1.1 (K965010)GE Medical Systems1997-07-23
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) (K971968)Remington Medical, Inc.1997-07-23
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM (K971784)Zeus Scientific, Inc.1997-07-23
CARDIAC PHASED ARRAY COIL (K971667)GE Medical Systems1997-07-23
ENVOY GUIDING CATHETER (K965247)Cordis Neurovascular, Inc.1997-07-23
MIRACLE-EAR ITE DIGITAL (K972346)Miracle-Ear, Inc.1997-07-23
JAZZ PP AGC-O, JAZZ PP (K972542)Trutone1997-07-23
MYRINGOTOMY TUBE (K971943)Mednet Locator, Inc.1997-07-23
SLED, FINGER, HANDLE (K971942)Biosound Esaote, Inc.1997-07-23
INTRODUCER SHEATH AND DILATOR (K971165)Boston Scientific Corp1997-07-23
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR (K971669)Cobe Cardiovascular, Inc.1997-07-23
TWIST PPAGC-1, TWIST PP (K972543)Trutone1997-07-23
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER (K971516)Cordis Corp.1997-07-23
FENWAL 40 MICRON TRANSFUSION FILTER (K972159)Baxter Healthcare Corp1997-07-23
DEEG-LITE (K972202)Grass-Telefactor Product Group1997-07-23
AMMONIA/IRON STANDARD KIT (K972333)Verichem Laboratories, Inc.1997-07-23
ARTHROCARE ELECTROSURGERY SYSTEM (K971532)Arthrocare Corp.1997-07-23
TARGET CARDIAC TROPONIN I TEST (K972094)Texas Immunology, Inc.1997-07-23
DAHLBERG/MIRACLE-EAR (K972345)Miracle-Ear, Inc.1997-07-23
MERIDIAN DSP (K972431)Micro-Ear Technology, Inc.1997-07-23
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES (K971843)Laserscope1997-07-23
SHARPLAN ERBIUM: YAG LASER (4020) (K971648)Sharplan Lasers, Inc.1997-07-23
PERSONALLAB AUTOMATED MICROPLATE ANALYZER (K971761)Biochem Immunosystems (U.S.), Inc.1997-07-22
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) (K972404)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-07-22
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 (K971437)Murray Electronics1997-07-22
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD (K963898)Medtronic Vascular1997-07-22
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT (K971797)Louisville Laboratories, Inc.1997-07-22
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) (K972041)Sigma Diagnostics, Inc.1997-07-22
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K971754)Pointe Scientific, Inc.,1997-07-22
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM (K962950)Varian Medical Systems, Inc.1997-07-22
TOX A/B TEST (K971182)Techlab, Inc.1997-07-22
OPUS ETHANOL (K972011)Behring Diagnostics, Inc.1997-07-22
LAPAROTOMY BLADDER NECK SUSPENSION KIT (K971801)Louisville Laboratories, Inc.1997-07-22
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Every clearance here is in the API, with alerts when new ones post.