Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
R.TEST EVOLUTION (K993788)Novacor Div.2000-08-04
RANDOX C-REACTIVE PROTEIN (K001009)Randox Laboratories, Ltd.2000-08-04
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST (K994400)Alfa Scientific Designs, Inc.2000-08-04
WATER PURIFIER (K001878)Waterclave, LLC2000-08-03
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) (K993442)Vygon Corp.2000-08-03
DETRUSAN 500 (K994109)Innovamed USA, Inc.2000-08-03
TAMPONS (K001641)Rostam , Ltd.2000-08-03
EXCELSIOR 1018 MICROCATHETER (K994155)Boston Scientific, Target2000-08-03
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 (K002212)Micro Therapeutics, Inc.2000-08-03
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 (K002053)Orthosoft, Inc.2000-08-03
VYGON 2 FR EPICUTANEO PUR-CATHETER (K993052)Vygon Corp.2000-08-03
BREAS PV 100 CPAP SYSTEM (K001553)Vital Signs, Inc.2000-08-03
LUBRIGEL PERSONAL LUBRICANT (K001077)Sheffield Laboratories, Div. of Faria Limited, LLC2000-08-02
DND 101 (K001590)Urogyn , Ltd.2000-08-02
GALEO HYDRO AND GALEO HYDRO J-TIP (K001736)Biotronik, Inc.2000-08-02
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE (K990100)Te ME NA S.A.R.L.2000-08-02
SIGMA (K001928)Instrumentarium Imaging, Inc.2000-08-02
STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER (K001825)Standard Imaging, Inc.2000-08-02
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER (K001409)Hyperbaric Technologies, Inc.2000-08-02
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A (K002009)Agilent Technologies, Inc.2000-08-02
WATER FOR TISSUE CULTURE, MODELS 1500 (K993140)Conception Technologies2000-08-02
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (K001555)Sims Portex , Ltd.2000-08-02
CHASE CARDIOVASCULAR PATCH (K001662)Chase Medical, Inc.2000-08-02
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 (K001182)Microlife Corp.2000-08-01
A.V. FISTULA NEEDLE (K001496)Exelint International, Co.2000-08-01
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS (K993524)Alaris Medical Systems, Inc.2000-08-01
PHORESOR MODEL PM2000 (K001410)Iomed, Inc.2000-08-01
ULTRASOUND SCANNER, TYPE 1101 (K002085)B & K Medical A/S2000-08-01
WIN-1 TANGO (K000204)Duracare Medical Equipment, L.C.2000-08-01
EXPLORER CVS TRANSCRANIAL DOPPLER (K990517)Diagnostic Medical Systems2000-08-01
DA VINCHI EMG/EP ISA1004EP (K001467)Airsep Corp.2000-08-01
COAXIAL DILATOR SET (K000737)Xentek Medical, Inc.2000-08-01
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM (K002185)Medison America, Inc.2000-08-01
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM (K001400)Siemens Medical Solutions USA, Inc.2000-08-01
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM (K992905)Codman & Shurtleff, Inc.2000-08-01
SURGIFLATOR-40 (K001533)W.O.M. Gmhb2000-07-31
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM (K001883)Ansell Healthcare, Inc.2000-07-31
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (K001690)Johnson & Johnson Medical, Inc.2000-07-31
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K001539)Bausch & Lomb, Inc.2000-07-31
DC TITAN (K001798)Austenal, Inc.2000-07-31
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 (K001515)The Prometheus Group2000-07-31
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K002175)Sgmp Co., Ltd.2000-07-31
ADVANCED UROSCIENCE INJECTION NEEDLE (K002323)Advanced Uroscience, Inc.2000-07-31
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER (K002101)AngioDynamics, Inc.2000-07-31
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE (K002176)Sgmp Co., Ltd.2000-07-31
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 (K002211)Baxter Healthcare Corp2000-07-28
SYNTHES BIORESORBABLE SUTURE ANCHOR (K994161)Synthes (Usa)2000-07-28
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 (K001873)Fresenius Medical Care North America2000-07-28
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 (K001378)Bionx Implants, Inc.2000-07-28
DATA MASTER PERFUSION MONITORING SYSTEM (K001388)Dideco2000-07-28
MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001753)Barco NV Display Systems2000-07-27
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT (K001374)Biomet Manufacturing, Inc.2000-07-27
HARDY DISK CLARITHROMYCIN, 15MCG (K001728)Hardy Diagnostics2000-07-27
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P (K001739)Allegiance Healthcare Corp.2000-07-27
INVERNESS MEDICAL EARLY PREGNANCY TEST (K002049)Selfcare, Inc.2000-07-27
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES (K000050)Top Quality Mfg., Inc.2000-07-27
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES (K001527)Fotona D.D.2000-07-27
CARDIOVISE ECG INTERPRETATIVE SOFTWARE (K001349)Inovise Medical, Inc.2000-07-27
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 (K002192)Ansell Perry2000-07-27
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE (K001616)Abbott Laboratories2000-07-27
MODIFICATION TO PROVIDENT HIP SYSTEM (K001745)Stelkast Company2000-07-27
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS (K001536)Sulzer Orthopedics, Inc.2000-07-27
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST (K994398)Alfa Scientific Designs, Inc.2000-07-27
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER (K002106)Biomet, Inc.2000-07-27
E-Z LINK CROSS CONNECTOR (K001372)Depuyacromed2000-07-27
SOLAR SHOULDER OFFSET HUMERAL HEAD (K001419)Howmedica Osteonics Corp.2000-07-27
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS (K001385)Howmedica Osteonics Corp.2000-07-27
MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001748)Barco NV Display Systems2000-07-27
EPI-STAR SURGICAL LASER SYSTER (K990119)Nidek, Inc.2000-07-27
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) (K001497)Multisafe Sdn. Bhd.2000-07-26
SMILIE PC (K001445)Julie Alliance2000-07-26
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) (K001619)Multisafe Sdn. Bhd.2000-07-26
DRX HBA1C (K000887)Metrika, Inc.2000-07-26
GASTRIC LAVAGE VALVE (K990365)T-Med Vac Corporation2000-07-26
GENERIC BLOOD GLUCOSE TEST STRIP (K001092)Inbios Intl., Inc.2000-07-26
STACKABLE CAGE SYSTEM (K001340)Depuyacromed2000-07-26
TRI-LOCK HIP STEM (K001982)DePuy Orthopaedics, Inc.2000-07-26
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K001959)Hartalega Sdn Bhd2000-07-26
VOCOM SILICONE SYSTEM (K001466)Smith & Nephew, Inc.2000-07-26
PATIENT MATCHED TITANIUM ALLOY TROCHLEA (K001350)Biomet, Inc.2000-07-26
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE (K001836)Shanghai Poseidon Plastic Products Co., Ltd.2000-07-26
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS (K002033)Becton Dickinson Infusion Therapy Systems, Inc.2000-07-26
RESPIEVENTS, VERSION 4.2 (K001369)Non-Invasive Monitoring Systems, Inc.2000-07-26
OPTICAL TRACKING SYSTEM (OTS) (K001950)Radionics, Inc.2000-07-26
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS (K002115)A&D Engineering, Inc.2000-07-25
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT (K001957)Howmedica Osteonics Corp.2000-07-25
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES (K001989)Zimmer, Inc.2000-07-25
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW (K001323)Nuvasive, Inc.2000-07-25
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K001375)Best Manufacturing Company2000-07-25
MEDSCOPE (K001314)All-Pro Imaging Corp.2000-07-25
SL-PLUS AND SLR-PLUS STEMS (K001942)Plus Orthopedics2000-07-25
BLAINE SCARCARE PATCH (K001608)Blaine Labs, Inc.2000-07-25
SURGITRON IEC II (K001407)Ellman Intl., Inc.2000-07-24
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (K001032)Otsuka Pharmaceutical Co., Ltd.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET (K001931)Wako Chemicals USA, Inc.2000-07-24
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES (K002071)Tissue Technologies, Inc.2000-07-24
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA (K001929)Wako Chemicals USA, Inc.2000-07-24
BONUS MECHANICAL WHEELCHAIR (K001391)Bonus Ent. Corp.2000-07-24
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) (K001558)Trek Diagnostic Systems, Inc.2000-07-24
SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR) (K001890)Otto Bock Orthopaedische Industrie, Kg.2000-07-24
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