Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DELSONIC 2000 (K990546)Sds Dental, Inc.1999-11-05
ECHO SCAN, EASY SCAN (K993394)Tomtec Imaging Systems GmbH1999-11-05
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED (K992924)Latexx Partners Bhd.1999-11-05
PASCO MIC AND MIC/ID PANELS, CEFDINIR (K992853)Pasco Laboratories, Inc.1999-11-04
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 (K990229)Justec Medical Products, Inc.1999-11-04
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY (K984631)Becton Dickinson Microbiology Systems1999-11-04
BIO-RAD CODA NEONATAL GALT ASSAY (K993536)Bio-Rad1999-11-04
BRAVO MULTI-MODALITY SYSTEM (K991054)Nicolet Biomedical, Inc.1999-11-03
OLYMPUS NA-10J-KB ASPIRATION NEEDLE (K991672)Olympus America, Inc.1999-11-03
FACE-2-FACE CPR PROTECTION SHIELD (K991617)Whiteline Plastics, Inc.1999-11-03
SYNERCID, 15 UG, BBL SENSI-DISC (K993186)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-11-03
DEVILBISS 5 LITER OXYGEN CONCENTRATOR (K991722)Sunrise Medical Hhg, Inc.1999-11-03
SIEMENS FIO2 SENSOR (K991884)Siemens Medical Solutions USA, Inc.1999-11-03
MUSE CARDIOVASCULAR INFORMATION SYSTEM (K992637)General Electric Medical Systems Information Techn1999-11-03
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS (K992726)Pasco Laboratories, Inc.1999-11-03
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) (K993306)Paladin Medical, Inc.1999-11-03
AXON MP-1 MICROPOSITIONER (K990683)Axon Instruments, Inc.1999-11-03
THE BRUNO POWERBASE, MODEL PSB-2200 (K991954)Bruno Independent Living Aids, Inc.1999-11-02
SYNTHES CERCLAGE POSITIONING PIN (K992891)Synthes (Usa)1999-11-02
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM (K992492)Roche Diagnostics Corp.1999-11-02
CDTOX A OIA (K991829)Biostar, Inc.1999-11-02
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4. (K992310)Rupiani Medical1999-11-02
COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION (K993517)Medison America, Inc.1999-11-02
BARD HYDROPHILIC COATED GUIDE WIRES (K993000)C.R. Bard, Inc.1999-11-02
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F (K992843)Ohio Medical Instrument Co., Inc.1999-11-02
DECAP (K993147)The Kipp Group1999-11-02
SERAQUEST EB NA IGG (K991975)Quest Intl., Inc.1999-11-02
AD-TECH'S FORAMEN OVALE ELECTRODE (K990788)Ad-Tech Medical Instrument Corp1999-11-02
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN (K992717)Pasco Laboratories, Inc.1999-11-02
KSEA DE LA PLAZA BLEPHAROPLASTY SET (K991592)KARL STORZ Endoscopy-America, Inc.1999-11-02
TRAY-LINK (K992001)Silicon-Und Composite Spezialitaten GmbH1999-11-02
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) (K991015)Lamda Polytech , Ltd.1999-11-02
MITEK MINI ANCHOR (K992623)Mitek Products1999-11-02
IF8000 (K991241)Dan Med, Inc.1999-11-02
WHEELCHAIR (MANUAL, NOT ELECTRICAL) (K992884)Foshan Machinery & Equipment Import & Export Co.1999-11-02
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR (K992599)Dideco S.P.A.1999-11-01
SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM (K984203)Shantou Institute of Ultrasonic Instuments1999-11-01
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM (K990826)Siemens Medical Solutions USA, Inc.1999-11-01
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (K992323)Datex-Ohmeda, Inc.1999-11-01
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA (K992512)Imcor1999-11-01
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K (K993387)Baxter Healthcare Corp1999-11-01
RAPICURE 200 (CURING AND WHITENING LIGHT) (K993223)Mediphotonix, LC1999-11-01
IL TEST VON WILLEBRAND FACTOR (K992704)Instrumentation Laboratory CO1999-11-01
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN (K991483)Abbott Laboratories1999-11-01
QUANTECH CK-MB ASSAY (K984433)Quantech , Ltd.1999-11-01
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD (K993034)Medica, Inc.1999-11-01
ABSOGEL CHEMOTHERAPHY GLOVES (K990677)Ampri Rubberware Industries Sdn Bhd1999-11-01
HRW WRIST ARRAY COIL (K993477)Mri Devices Corp.1999-11-01
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR (K992976)Kamiya Biomedical Co.1999-11-01
DR. JAHANGER'S CUTTER (K990738)M.S. Jahanger, MD1999-10-29
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES (K992841)Tg Medical Sdn. Bhd.1999-10-29
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A (K992574)Trimedyne, Inc.1999-10-29
ATD AUTOMATIC BRIDGE REMOVER (K992649)J. Morita USA, Inc.1999-10-29
MAPS 10000 (K992560)Web Link Medical1999-10-29
PALMAZ XL TANSHEPATIC BILIARY STENTS (K993091)Cordis Corp.1999-10-29
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM (K992953)Ansell Perry1999-10-29
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) (K993093)Pamitex Industries Sdn Bhd1999-10-29
RESPALERT (K992618)Harwill Medical (Pty) , Ltd.1999-10-29
QUICKSTRIP ONE STEP OPIATES TEST (K993490)Syntron Bioresearch, Inc.1999-10-29
QUICKPAC II ONE STEP OPIATES TEST (K993491)Syntron Bioresearch, Inc.1999-10-29
NUTRISAFE EXTENSION TUBE (K991918)Vygon Corp.1999-10-29
MASS (MICRO-ACCESS SPINE SYSTEM) (K992583)Omni-Tract Surgical, Div. Minn. Scientific, Inc.1999-10-29
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K993287)Pan-Century Rubber Products Sdn. Bhd.1999-10-29
KONICA LASER IMAGER, DRYPRO MODEL 722 (K992586)Konica Corp.1999-10-29
PROWLER PLUS INFUSION CATHETER (K993266)Cordis Neurovascular, Inc.1999-10-28
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE (K992169)Advanced Cardiovascular Systems, Inc.1999-10-28
DUAL LUMEN CATHETER, MODEL DL-35-90 (K991601)Endologix, Inc.1999-10-28
SERAQUEST EB VCA IGG (K990410)Quest Intl., Inc.1999-10-28
K-ASSAY APO B (K993354)Kamiya Biomedical Co.1999-10-28
SPRING-WOUND EPIDURAL CATHETER (K991879)Micor, Inc.1999-10-28
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM (K993245)Alba Critical Care, Ltd.1999-10-28
MODEL IRC 1001 AEROSOL COMPRESSOR (K992643)Invacare Corp.1999-10-27
ROTORBLADE SUTURE ANCHOR (K993373)Li Medical Technologies, Inc.1999-10-27
ALPHA INFUSION PUMP (K992551)Advanced Infusion, Inc.1999-10-27
VIRTUOSO LX SMART CPAP SYSTEM (K993433)Respironics, Inc.1999-10-27
CRICOTHYROTOMY TUBE (K983000)Polamedco, Inc.1999-10-27
ZMR HIP SYSTEM-REVISION TAPER (K992667)Zimmer, Inc.1999-10-27
ILLUSION (K993192)Bisco, Inc.1999-10-27
SHELLY PROTECTED AV FISTULA NEEDLE (K992653)Diasol, Inc.1999-10-27
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES (K992156)Ansell Perry1999-10-27
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE (K992830)Safeskin Corp.1999-10-27
OXYCONALPHA WITH OPTION ECG (K984465)Erich Jaeger B.V.1999-10-27
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES (K993258)Supermax Sdn Bhd1999-10-27
ST-302 INFRAREX (K990233)Skylark Device Co., Ltd.1999-10-27
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES (K983613)Shanghai Jiatai Plastic Products Co., Ltd.1999-10-27
BARIATRIC LAPAROSCOPE, MODEL 367 (K993045)Stryker Endoscopy1999-10-27
SDB CERCLAGE SYSTEM (K992616)Pioneer Surgical Technology1999-10-27
COOK ULTRA QUIET VACUUM PUMP & REGULATOR (K992070)Cook Urological, Inc.1999-10-27
IV ADMINISTRATION SET (K992266)New Alliance of Independent Medical Distributors,1999-10-27
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 (K992421)Accutron, Inc.1999-10-27
HEX BUTTON (K992617)Pioneer Surgical Technology1999-10-27
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES (K993240)Shinemound Enterprise, Inc.1999-10-27
TUBULAR ELECTRODE DEVICE (K992542)Conway Stuart Medical, Inc.1999-10-27
IQ NASAL MASK, MODEL P/N 50160 (K993269)Sleepnet Corporation1999-10-27
ARIA LX CPAP SYSTEM (K993307)Respironics, Inc.1999-10-27
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES (K993231)Shinemound Enterprise, Inc.1999-10-27
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM (K993097)Pamitex Industries Sdn Bhd1999-10-27
NEXT GENERATION RODDING SYSTEM (K992784)United States Surgical, A Division of Tyco Healthc1999-10-27
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 (K992601)Oriental System Technology, Inc.1999-10-27
ELECTRIC MOBILITY CAVALIER SCOOTERS (K991281)Electric Mobility, LLC1999-10-27
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