Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DEPUY ACE SPIDER PLATE (K984458)Depuy Ace Medical Co.1998-12-31
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS (K981680)Dayton Water Systems1998-12-31
'RAPID DRUG SCREEN' 9-PANEL (K983770)American Bio Medica Corp.1998-12-31
INSTATRAK 3000 (K983529)Visualization Technology, Inc.1998-12-31
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM (K983976)Metagen, LLC1998-12-30
ANTERIOR CERVICAL PLATING SYSTEM (K984342)United States Surgical, A Division of Tyco Healthc1998-12-30
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC (K982549)Radionics, Inc.1998-12-30
COMFEEL SEASORB DRESSING (K983519)Coloplast Corp.1998-12-30
DIGORA FOR WINDOWS 2.0 (K983267)Orion Corporation Soredex1998-12-30
ULTIMA AIRFLOW PRESSURE SENSOR (K984431)Braebon Medical Corp.1998-12-30
MOUNTABLE ENDOSCOPIC KNIFE (K982142)A.M. Surgical, Inc.1998-12-30
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM (K983873)Syntec Scientific Corp.1998-12-30
SYSTEM U3 FOR TETRACYCLINE (K983571)Ab Biodisk1998-12-30
XRE COLLIMATOR WITH SPECTRAL FILTER (K984414)Trex Medical Corp.1998-12-30
DEPUY ACROMED MOSS SPINAL SYSTEM (K984378)Depuy, Inc.1998-12-30
BODYFORM THORACO-LUMBAR FIXATION SYSTEM (K983622)Theken Surgical,Llc1998-12-30
AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 (K983761)Aaron Medical Industries1998-12-30
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 (K983055)Guidant Corp.1998-12-30
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II (K983747)Beckman Coulter, Inc.1998-12-30
ROCS TPS (K982791)Radiation Oncology Computer Systems1998-12-30
NEUROMAG VECTORVIEW (K984401)Philips Medical Systems (Cleveland), Inc.1998-12-30
JELBOND NP (K984164)Jelenko Co.1998-12-29
VARIABLE PRESSURE SYRINGE PUMP (K974332)Alaris Medical Systems, Inc.1998-12-29
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 (K983535)Hans Hermann GmbH1998-12-29
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER (K982337)Haidylena Medical Egypt1998-12-29
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY (K983990)Ortho-Clinical Diagnostics, Inc.1998-12-29
GREINER VACUETTE BLOOD COLLECTION TUBE (K983952)Greiner Meditech, Inc.1998-12-28
PULMOTRACK,MODEL 1010 (K980878)Karmel Medical Acoustic Technologies , Ltd.1998-12-28
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (K983484)Empi1998-12-28
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER (K982562)Integrated Orbital Implants, Inc.1998-12-28
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION (K984535)Puritan Bennett Corp.1998-12-28
AUTOSTAT II ENA SCREEN ELISA (K983921)Cogent Diagnotics , Ltd.1998-12-28
UNIPOLAR OPTICAL BIOPSY FORCEPS (K983811)Olympus Winter & Ibe GmbH1998-12-24
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR (K983559)Icu Medical, Inc.1998-12-24
TRIP TONOMETRY CATHETER, 16F (K983366)Datex-Engstrom, Inc.1998-12-23
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 (K984211)Medscand AB1998-12-23
AIA-PACK TROPONIN I ASSAY (K984359)Tosoh Medics, Inc.1998-12-23
VITALCARE DISPOSABLE VAGINAL SPECULUM (K983716)Vitalcare Group, Inc.1998-12-23
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT (K984145)Olympus Diagnostica GmbH1998-12-23
AGATHA-A-H2010 (K983374)Midian Intl.1998-12-23
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K982897)Pt. Maja Agung Latexindo1998-12-23
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 (K984384)Thermo Bioanalysis Corp.1998-12-23
SYSTEM U3 FOR NORFLOXACIN (K983486)Ab Biodisk1998-12-23
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A (K983516)Toshiba America Medical Systems, In.C1998-12-23
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) (K984019)Kossan Latex Industries(M)Sdn Bhd1998-12-23
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) (K984020)Kossan Latex Industries(M)Sdn Bhd1998-12-23
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K984500)Cordis Corp.1998-12-23
PROGUARD, RR-1, RR-2 (K982832)Emerson & Co. Srl1998-12-23
POSITRON OPTION, MODEL NSCO-050A (K983514)Toshiba America Medical Systems, In.C1998-12-23
SOLARTEC SOURCE 270, MODEL # 90123 (K983714)Cogent Light Technologies, Inc.1998-12-23
MICRO DYNAMIC MESH (K983528)Howmedica Corp.1998-12-23
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K984014)Beckman Coulter, Inc.1998-12-23
SUPER PORCELAIN STAIN- PURE WHITE (K983470)Noritake Co., Inc.1998-12-22
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) (K981554)Micra Instruments , Ltd.1998-12-22
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 (K984473)Bio-Rad1998-12-22
REAADS IGA ANTI-B2GP 1 TEST KIT (K982434)Corgenix, Inc.1998-12-22
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME (K980675)Summit Technology, Inc.1998-12-22
OPTICOAT T3 EIA KIT (K981824)Biotecx Laboratories, Inc.1998-12-22
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT (K983914)Corgenix, Inc.1998-12-22
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS (K982344)Wesley Jessen Corp.1998-12-22
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D (K983653)Cardiac Pathways Corp.1998-12-22
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 (K984319)Bio-Rad1998-12-22
SUPER SEAL (K983477)Phoenix Dental, Inc.1998-12-22
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM (K984173)Zeus Scientific, Inc.1998-12-22
CS/3 COMPACT AIRWAY MODULE, M-COVX (K982091)Datex-Engstrom, Inc.1998-12-22
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST (K981363)Tcpi, Inc.1998-12-22
LS SERIES 200 FLOVISION SYSTEM (K971981)Systam1998-12-22
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 (K984479)Bio-Rad1998-12-22
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (K984476)Bio-Rad1998-12-22
ROGOZINSKI SPINAL ROD SYSTEM (K983904)United States Surgical, A Division of Tyco Healthc1998-12-22
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 (K984470)Bio-Rad1998-12-22
ADVENT (K984112)Bisco, Inc.1998-12-22
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS (K983773)Benz Research and Development Corp.1998-12-22
TYPE 3 FEMORAL COMPONENTS (K983404)Howmedica Corp.1998-12-22
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 (K984478)Bio-Rad1998-12-22
CROSSLAPS ELISA (K972788)Devices and Diagnostics Consulting Group1998-12-22
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 (K984327)Bio-Rad1998-12-22
DEPUY ACE TIMAX META PLATE (K983853)Depuy Ace Medical Co.1998-12-22
PHUSIS ABSORBABLE INTERFERENCE SCREW (K970829)Tornier1998-12-22
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 (K984464)Bio-Rad1998-12-22
CO2 LASER COUPLER (K983965)L.A.S.E.R., Inc.1998-12-22
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 (K984475)Bio-Rad1998-12-22
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) (K983899)United States Surgical, A Division of Tyco Healthc1998-12-22
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 (K984462)Bio-Rad1998-12-22
LIGHT DIAGNOSTICS RABIES DFA REAGENT (K972975)Light Diagnostics1998-12-22
MIR SPIROBANK SPIROMETER (K983909)Mir Medical Intl. Research Srl1998-12-21
OWEN MUMFORD 3ML AUTOPEN (K983974)Owen Mumford USA, Inc.1998-12-21
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE (K983342)Philips Medical Systems (Cleveland), Inc.1998-12-21
MODEL MS-1 HANDPIECE (K983413)Parkell, Inc.1998-12-21
EMBRYO TRANSFER CATHETERS/SETS (K983594)Cook Ob/Gyn1998-12-21
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED (K982901)Vitalcare Group, Inc.1998-12-21
SYNTHES 1.3 MM SELF-DRILLING SCREW (K983485)Synthes (Usa)1998-12-21
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER (K983568)Contract Latex Dippers Sdn Bhd1998-12-21
INTRATUBAL TRANSFER SETS (K983591)Cook Ob/Gyn1998-12-21
PHILIPS INTEGRIS 3D RA OPTION (K983877)Philips Medical Systems North America, Inc.1998-12-21
INSIGHT DIAGNOSTIC IMAGING WORKSTATION (K982535)Neo Imagery Technologies, Inc.1998-12-21
SYNCHRON SYSTEMS LIPID CALIBRATOR (K983640)Beckman Coulter, Inc.1998-12-21
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE (K983731)Pall Medical1998-12-21
GIFT CATHETER SET/S (K983590)Cook Ob/Gyn1998-12-21
STRYKER WEDGE SUTURE ANCHOR (K983557)Stryker Endoscopy1998-12-18
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Every clearance here is in the API, with alerts when new ones post.