Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
QSC-63-INT SHOULDER ARRAY COIL SET (K022910)Mri Devices Corp.2002-10-03
CSV12 SOFTWARE VIEWER (K022896)Acuson Corp.2002-10-03
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC (K020334)Jac-Cell Medic Corporation2002-10-03
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE (K022904)Wrp Asia Pacific Sdn. Bhd.2002-10-03
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS (K022475)Arthrocare Corp.2002-10-03
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE (K022485)Datex-Ohmeda2002-10-03
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) (K022808)Wrp Specialty Products Sdn. Bhd.2002-10-03
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM (K023053)Smith & Nephew, Inc.2002-10-03
AURORA SR (K022266)Syneron Medical, Ltd.2002-10-03
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V (K022300)Dental Vipi Ltda2002-10-03
DISPOSABLE N-PE MICROKERATOME BLADES (K022205)Oasis Medical, Inc.2002-10-03
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 (K020810)bioMerieux, Inc.2002-10-03
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE (K022867)Cliniqa Corporation2002-10-02
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE (K022936)Cliniqa Corporation2002-10-02
PROXILOCK HIP PROSTHESIS; SIZE 12/36 (K022966)Implex Corp.2002-10-02
TOKUYAMA REBASE II (K022641)Tokuyama America, Inc.2002-10-02
ENDIUS ATAVI SYSTEM (K022199)Endius, Inc.2002-10-02
LIGHT TIP (K022265)Svenska Dental Instruments AB2002-10-02
BIOVER (K011208)Biover AG2002-10-02
BONE GRAFT SYRINGE, MODEL 8600-00X0 (K023088)Wrightmedicaltechnologyinc2002-10-02
BREATHABLE SURGICAL GOWN (K023167)Allegiance Healthcare Corp.2002-10-02
CLEAN 'N' OIL (K022264)Svenska Dental Instruments AB2002-10-02
TOTAL HIP FEMORAL HEADS AND LINERS (K022958)Smith & Nephew, Inc.2002-10-02
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE (K022885)Cliniqa Corporation2002-10-02
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K022953)Schick Technologies, Inc.2002-10-02
SMITH & NEPHEW HIP SYSTEM (K022902)Smith & Nephew, Inc.2002-10-02
I-STETHOS LINK (K022298)Andromed, Inc.2002-10-01
UNITY NETWORK ID (K021454)General Electric Medical Systems Information Techn2002-10-01
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 (K021142)Fortune Medical Instrument Corp.2002-10-01
SNIFF POSITION PILLOWS/POPITZ PILLOWS (K023010)Aeolus International Corporation2002-10-01
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
PMX DISPOSABLE BAG MASK RESUSCITATOR (K014071)Allied Healthcare Products, Inc.2002-10-01
QIVA (K021495)Pie Medical Imaging BV2002-10-01
LIVESIRE ELECTROPHYSIOLOGY CATHETER (K022380)St Jude Medical2002-10-01
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY (K011493)Mentor Corp.2002-10-01
SPIFE LD-12 KIT, MODEL 3338 (K022455)Helena Laboratories2002-10-01
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES (K022181)Lumenis, Inc.2002-10-01
BIOLOGICAL SOUND MONITOR (BSM) SENSOR (K021389)Andromed, Inc.2002-10-01
WHISPER WEAR BREAST PUMP (K022140)Whisper Wear2002-09-30
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (K022409)Spectral Diagnostics, Inc.2002-09-30
HARMONY INR MONITORING SYSTEM (K022922)Lifescan, Inc.2002-09-30
FASTPACK TESTOSTERONE CALIBRATOR (K022533)Qualigen, Inc.2002-09-30
EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET (K022406)Exelint Intl. Co.2002-09-30
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K012138)Chroma Vision Medical Systems, Inc.2002-09-30
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (K022154)Fischer Industries, Inc.2002-09-30
BIO-RAD PLATELIA TOXO IGG TMB (K013839)Bio-Rad2002-09-30
BIO-RAD PLATELIA TOXO IGM TMB (K013837)Bio-Rad2002-09-30
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT (K023062)Abbott Laboratories, Inc.2002-09-30
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512)Immunicon Corp.2002-09-30
LDL CHOLESTEROL (AUTOMATED) (K022519)Jas Diagnostics, Inc.2002-09-30
EBV EA-D IGG ELISA KIT, MODEL EBG-100 (K021793)Pan Bio Pty. , Ltd.2002-09-27
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K022552)Cook, Inc.2002-09-27
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 (K022424)Nobel Biocare Uas, Inc.2002-09-27
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 (K021814)Beckman Coulter, Inc.2002-09-27
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS (K022901)Ortho-Clinical Diagnostics2002-09-27
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 (K021266)Ethicon Endo-Surgery, Inc.2002-09-27
PH AND AMINES EXTERNAL CONTROL SET (K022851)Quidel Corp.2002-09-27
DAYTRIPPER DIALYSATE WARMER (K020542)Stickman Industries, Inc.2002-09-27
GLOBAL ECG MANAGEMENT SYSTEM (GEMS) (K022297)Cardiocomm Solutions, Inc.2002-09-27
M2 SINGLE USE MICROKERTOME (K022560)Moria SA2002-09-27
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR (K022115)Terumo Corp.2002-09-27
HRK-63 KNEE ARRAY COIL (K022883)Mri Devices Corp.2002-09-27
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE (K013875)Med-Tec,Inc.2002-09-27
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM (K022103)Puritan Bennett Corp.2002-09-27
PULPDENT PUTTY DAM (K022522)Pulpdent Corporation2002-09-26
CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED) (K022792)Seal Polymer Industries Bhd.2002-09-26
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE (K023020)Agfa Corp.2002-09-26
CHLORAPREP (K021131)Centrix, Inc.2002-09-26
AUTO*THERM 395, MODEL ME 395 (K022458)Mettler Electronics Corp.2002-09-26
MICRORUPTER V (K023045)Meridian AG2002-09-26
ATLAS MONITOR, MODELS 200,210,220 (K022084)Welch Allyn, Inc.2002-09-26
DOCXS B SERIES ELECTRODES (K020903)Docxs, LLC2002-09-26
TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 (K023024)Vascular Control Systems, Inc.2002-09-26
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE (K020457)Axiamed, Inc.2002-09-26
REPLACE TIUNITE ENDOSSEOUS IMPLANT (K023113)Nobel Biocare Uas, Inc.2002-09-26
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 (K022992)Corgenix, Inc.2002-09-25
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K022775)Trek Diagnostic Systems, Inc.2002-09-25
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER (K022889)Siemens Medical Solutions USA, Inc.2002-09-25
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 (K022100)Image-Guided Neurologics, Inc.2002-09-25
CARDIS (K023015)Schwarzer GmbH2002-09-25
BARDPORT X-PORT ISP PORT (K022983)C.R. Bard, Inc.2002-09-25
INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM (K020786)Rosch AG Medizintechnic2002-09-25
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 (K022990)Corgenix, Inc.2002-09-25
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K021997)Trek Diagnostic Systems, Inc.2002-09-25
ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) (K022659)Purna Bina Sdn Bhd2002-09-25
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001 (K020879)Integrated Vascular Systems, Inc.2002-09-25
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 (K022187)Radi Medical Systems AB2002-09-24
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM (K022344)Centerpulse Spine-Tech, Inc.2002-09-24
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES (K021152)Computer Motion, Inc.2002-09-24
CADENCE SPINAL FIXATION SYSTEM (K022374)Sulzer Spine-Tech2002-09-24
SHORT AND LONG SOFT TISSUE ATTACHMENT (K022079)Biomet, Inc.2002-09-24
ICASE (K021248)Ikeeps, Inc.2002-09-24
PTS PANELS LIPID PANEL TEST STRIPS (K022898)Polymer Technology Systems, Inc.2002-09-24
NELLCOR N-200 PULSE OXIMETER, MODEL N-200 (K022819)Nellcor Puritan Bennett, Inc.2002-09-24
LIFEGUARD (K022755)Medtek, LLC2002-09-24
ADVIA TESTPOINT CSF CONTROL (K022968)Bayer Diagnostics Corp.2002-09-24
LUNEAU 3 MIRROR LENS (K022413)Luneau SA2002-09-24
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 (K020712)Biomedical Life Systems, Inc.2002-09-24
FIRST CHOICE & FIRST CHOICE PLUS (K022076)Body Clock Health Care, Ltd.2002-09-24
PULMOLAB EX671 EXERCISE TESTING SYSTEM (K020280)Morgan Medical , Ltd.2002-09-24
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Every clearance here is in the API, with alerts when new ones post.