Atlas FDA

1998

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

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RecordFirmDate
HISTOFREEZER DEVICE (K982358)OraSure Technologies, Inc.1998-10-02
OTI FEMORAL LOCK TOTAL HIP SYSTEM (K982598)Osteoimplant Technology, Inc.1998-10-02
STRYKER HIP ARTHOROSCOPY SET (K982375)Stryker Endoscopy1998-10-02
CONTEMPORARY ACETABULAR COMPONENT (K982670)Howmedica Corp.1998-10-02
NC-STAT (K982359)Neurometrix, Inc.1998-10-02
AESCULAP SPINE SYSTEM EVOLUTION (K980484)Aesculap, Inc.1998-10-02
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP (K982538)Belmont Instrument Corp.1998-10-02
TRIMETHOPRIM/SULPHAMETHOXAZOLE (K983027)Ab Biodisk1998-10-02
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K983023)Cordis Corp.1998-10-01
CHOLESTRON PRO II CHOLESTEROL TEST (K981345)Lifestream Diagnostics, Inc.1998-10-01
LINER 1:HARD RELINE LIQUID (K981861)Harry J. Bosworth Co.1998-10-01
UPRO (K981295)Abbott Laboratories1998-10-01
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT (K982848)Roche Diagnostic Systems, Inc.1998-10-01
VYGON DOUBLE LUMEN UMBILICAL CATHETER (K981630)Schiff & Co.1998-10-01
IMX HOMOCYSTEINE (K980812)Axis Biochemicals, Asa1998-10-01
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC (K983161)Sabre-K , Ltd.1998-09-30
TEMPFIL F - 2 (K982459)Sybron Dental Specialties, Inc.1998-09-30
UMECO OPTIMA 694 RUBY LASER SYSTEM (K982113)Umeco, Inc.1998-09-30
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP (K982256)Mckinley, Inc.1998-09-30
ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE (K982868)Ab Biodisk1998-09-30
DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER (K982781)Thermal Waste Technology, Inc.1998-09-30
SEARE BIOMEDICAL NASAL IMPLANTS (K982753)Seare Biomedical Corp.1998-09-30
SEARE BIOMEDICAL MALAR IMPLANTS (K982763)Seare Biomedical Corp.1998-09-30
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K982806)Perusahaan Getah Asas Sdn. Bhd.1998-09-30
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS (K982349)Siemens Medical Solutions USA, Inc.1998-09-30
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS (K982891)California Medical Laboratories, Inc.1998-09-30
EAGLESOFT CHAIRSIDE (K982422)Eaglesoft, A Patterson Co.1998-09-30
AVOCET PT (K980839)Avocet Medical, Inc.1998-09-30
OMNIFLATOR 6630(6-630-00) (K973447)Northgate Technologies, Inc.1998-09-30
DUOSTAR (K974170)Mti Corp./ Electrostar S.A.-Haiti1998-09-30
MEDIVISION CYSTOSCOPE (K982620)Medivision Scope Service Center, Inc.1998-09-30
NITRILE PATIENT EXAMINATION GLOVE (K982440)Perusahaan Getah Asas Sdn. Bhd.1998-09-30
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (K972866)International Technidyne Corp.1998-09-30
A1 ACOUSTIC RHINOMETER (K972140)G.M. Instruments , Ltd.1998-09-30
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES (K973203)Sangstat Medical Corp.1998-09-30
MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 (K982779)Medental Intl.1998-09-30
ORTHO IMPLANT AND ACCESSORIES (K982509)Straumann USA1998-09-30
SEARE BIOMEDICAL CHIN IMPLANTS (K982752)Seare Biomedical Corp.1998-09-30
EXTRACRANIAL RADIOTHERAPY SYSTEM (K982463)Howmedica, Inc.1998-09-30
SEARE BIOMEDICAL PECTORALIS IMPLANT (K982762)Seare Biomedical Corp.1998-09-30
SEARE BIOMEDICAL SILICONE SHEETING (K983041)Seare Biomedical Corp.1998-09-30
SYNTHETIC EXAMINATION GLOVE, POWDERED (K981876)Hsing YI Plastics Processing Co, Ltd.1998-09-30
HANDMASTER NMS1 (K982482)N.E.S.S. Nuromuscular Electrical Stimulation Syst1998-09-30
METRON QA-IDS I.V. PUMP TESTER (K982020)Metron U.S., Inc.1998-09-30
SEARE BIOMEDICAL SILICONE BLOCK (K983043)Seare Biomedical Corp.1998-09-30
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 (K981711)Dade Behring, Inc.1998-09-30
JOAN II (K982648)Celanese Acetate Co.1998-09-30
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 (K982822)Baxter Healthcare Corp1998-09-30
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A (K981337)Mesure Technology1998-09-30
CO2 GAS WARMING UNIT (6-800-00) (K972675)Northgate Technologies, Inc.1998-09-30
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K982704)Shanghai Antares Industries, Inc.1998-09-30
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K982807)Perusahaan Getah Asas Sdn. Bhd.1998-09-30
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM (K982623)Aesculap, Inc.1998-09-30
XKNIFE-4 (K981055)Radionics, Inc.1998-09-29
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983130)Kamiya Biomedical Co.1998-09-29
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983241)Kamiya Biomedical Co.1998-09-29
PHILIPS OMNIDIAGNOST (K982993)Philips Medical Systems, Inc.1998-09-29
AUTOMATED MEDICAL REPORT WRITER (K981553)Woodson and Associates, LLC1998-09-29
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (K981306)Diamedix Corp.1998-09-29
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM (K981834)Perception, Inc.1998-09-29
DYNAMIC SHIELDING RADIATION TABLE (K982446)American Biophysics, Inc.1998-09-29
HYBRID CAPTURE SYSTEM CMV DNA ASSAY (K974901)Digene Corp.1998-09-29
COMBISON 530D WITH POWER DOPPLER MODE (K974813)Medison America, Inc.1998-09-29
LSVP INTERNATIONAL BIOPSY FORCEPS (K982983)Lsvp Intl., Inc.1998-09-29
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P (K983147)Princeton BioMeditech Corp.1998-09-28
COAMATIC PLASMIN INHIBITOR (K981817)Instrumentation Laboratory CO1998-09-28
PGK DEVICE (MODIFIED) (K980997)Pgk, Inc.1998-09-28
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 (K981394)Braemar Corp.1998-09-28
IS-VZU IGG TEST SYSTEM (K981867)Diamedix Corp.1998-09-28
IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 (K981226)Dako Diagnostics , Ltd.1998-09-28
AST (K983131)Abbott Laboratories1998-09-28
COBAS INTEGRA REAGENT CASSETTES (K982382)Roche Diagnostic Systems, Inc.1998-09-28
SILVERLON CONTACT WOUND DRESSING (K981299)Argentum International, LLC1998-09-25
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES (K981940)Dexide, Inc.1998-09-25
BLUNT SYRINGE CANNULA (K971924)B.Braun Medical, Inc.1998-09-25
A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR (K982481)A&D Engineering, Inc.1998-09-25
HUMAPEN AND HUMAPEN ERGO (K982842)Eli Lilly and Co.1998-09-25
POC ENT ENDOSCOPE - SINUSCOPE (K983123)Precision Optics Corp.1998-09-25
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT (K982330)Depuy, Inc.1998-09-25
PRESS-MATE ADVANTAGE (K973637)Colin Medical Instruments Corp.1998-09-25
THE BONE TIE (K982719)Surgicraft , Ltd.1998-09-25
HYDROCISION ARTHROJET SYSTEM (K982266)Hydrocision, Inc.1998-09-25
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS (K983152)Osteonics Corp.1998-09-25
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L (K980817)Interpore Intl.1998-09-25
DEVILBISS SUCTION UNIT (K982304)Sunrise Medical Hhg, Inc.1998-09-25
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (K982279)Bci Intl., Inc.1998-09-25
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A (K982300)Toshiba America Medical Systems, In.C1998-09-25
LASETTE LASER SKIN PERFORATOR (K982230)Cell Robotics, Inc.1998-09-24
ELECSYS MYOGLOBIN STAT ASSAY (K983176)Boehringer Mannheim Corp.1998-09-24
FREE T4 MICROWELL EIA, MODEL #7019 (K982954)Biomerica, Inc.1998-09-24
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 (K981985)Beckman Coulter, Inc.1998-09-24
AIR TECHNIQUES' AIRDENT II (K981564)Air Techniques, Inc.1998-09-24
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 (K974572)Chugai Pharmaceuticals Co., Ltd.1998-09-24
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL (K982172)Coulter Corp.1998-09-24
XENON LIGHT SOURCE, MODELS LS6180, LS6035 (K982962)Contec Medical Vision, Ltd.1998-09-23
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H (K974899)Gambro Healthcare1998-09-23
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C (K982427)Trex Medical Corp.1998-09-23
MAYFIELD ACCISS OPTICAL SYSTEM (K982244)Ohio Medical Instrument Co., Inc.1998-09-23
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT (K982960)Medical Device Technologies, Inc.1998-09-23
EWC: ECG CABLE AND LEADWIRE SYSTEMS (K982817)Ewc1998-09-23
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