Atlas FDA

2005

3,156 FDA 510(k) clearances · Clearance year

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RecordFirmDate
GE LOGIQ 7 ULTRASOUND BT05 (K052441)General Electric Co.2005-09-21
EBI DYNAFIX VISION FOOTPLATE SYSTEM (K052239)Ebi, L.P.2005-09-21
VENAFLO II VASCULAR GRAFT (K052282)Bard Peripheral Vascular, Inc.2005-09-20
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 (K051259)Theralight, Inc.2005-09-20
BLUEPHASE 16I (K051782)Ivoclar Vivadent, Inc.2005-09-20
NON-STERILE SURGICAL MASK (K051291)A.R. Medicom, Inc.2005-09-20
MAXIMUS 3.0 AND OS IMPLANTS (K052419)BioHorizons Implant Systems, Inc.2005-09-20
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH (K051357)Digitimer , Ltd.2005-09-20
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES (K051873)GE Healthcare2005-09-20
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM (K052444)Inion , Ltd.2005-09-20
MAYFIELD INFINITY SKULL CLAMP (K051440)Integra Lifesciences Corp.2005-09-20
O.A.S.I. SYSTEM (K051552)Lancer Orthodontics, Inc.2005-09-19
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 (K051750)Ultradent Products, Inc.2005-09-19
BIOBANDS (K051397)Biobands Distributors, Inc.2005-09-16
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ (K052412)GE Healthcare2005-09-16
MBCP (K051885)Biomatlante2005-09-16
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 (K052008)Imc-Heart Way LLC2005-09-16
NEURODRIVE SYSTEM (K051830)Alpha Omega , Ltd.2005-09-16
NUVASIVE NEUROVISION JJB SYSTEM (K051718)Nuvasive, Inc.2005-09-15
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K052382)Pt.Shamrock Manufacturing Corp.2005-09-15
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 (K051857)Weissburg Associates2005-09-15
CORONIS 3MP-21 AND MFGD 3621 (K052429)Barcoview2005-09-15
CORONIS 2MP-21 AND MFGD 2621 (K052403)Barcoview2005-09-15
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (K051997)Terumo Cardiovascular Systems Corp.2005-09-15
3I OSSEOTITE DENTAL IMPLANTS (K051461)Implant Innovations, Inc.2005-09-15
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER (K051313)Salter Labs2005-09-15
SCHUCO MIST AND SCHUCO DELUXE MIST (K051260)Allied Healthcare Products, Inc.2005-09-15
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX (K052247)Abbott Spine, Inc.2005-09-14
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K052355)U-Systems, Inc.2005-09-14
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM (K050382)Cynosure, Inc.2005-09-14
OSTEOPAL V (K050085)Heraeus Kulzer,GmbH2005-09-14
DORSAL NAIL PLATE, ANATOMICAL (K052248)Hand Innovations, LLC2005-09-14
PICONIBP OEM MODULE (K051366)Philips Medizin Systeme Boeblingen GmbH2005-09-14
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 (K051922)Cynosure, Inc.2005-09-14
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (K050524)Marda Medical, Inc.2005-09-14
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C (K052344)Eizo Nanao Corporation2005-09-14
SINGLE AMPLIFIER FOR BOTOX (K051852)Allergan, Inc.2005-09-14
ADVANTAGE SIM MD (K052345)GE Healthcare2005-09-14
ALCON MULTI-PURPOSE DISINFECTING SOLUTION (K050729)Alcon Research, Ltd.2005-09-14
ENDO-EASE ENDOSCOPIC OVERTUBE (K052084)Spirus Medical, Inc.2005-09-14
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K052325)Accuray Incorporated2005-09-14
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (K052454)Abbott Vascular Devices2005-09-14
POLARIS LV, LVA APPLICATOR (K052324)Syneron Medical, Ltd.2005-09-14
DUREPAIR DURA REGENERATION MATRIX (K052211)Medtronic Neurosurgery2005-09-14
ACCORDION (K052048)Percutaneous Systems, Incorporated2005-09-13
PRE-POWDERED STERILE EXAM GLOVES (K052214)Kanam Latex Industries Pvt. , Ltd.2005-09-13
CRONO GO. (K052219)Cane S.R.L.2005-09-13
B-BOP PLATE (K052152)New Deal, S.A.2005-09-13
SURGEON'S GLOVE, POWDER FREE (K052030)Shun Thai Rubber Gloves Industry Public Co., Ltd.2005-09-13
BD PEN NEEDLE (K051899)Becton, Dickinson & CO2005-09-13
COBRA SURGICAL SYSTEM (K051749)Estech, Inc.2005-09-13
CRONO SUPER PID (K052217)Cane S.R.L.2005-09-13
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K050760)Roche Diagnostics Corp.2005-09-13
CAPIOX AF125X ARTERIAL FILTER (K052205)Terumo Cardiovascular Systems Corp.2005-09-12
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA (K051565)Proton Healthcare , Ltd.2005-09-12
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (K052015)Dade Behring, Inc.2005-09-12
ANGIODYNAMICS, INC., MICRO ACCESS KITS (K051655)AngioDynamics, Inc.2005-09-12
BD PROBE TEC URINE PRESERVATIVE TRANSPORT (K052224)Becton, Dickinson & CO2005-09-12
POWDERED LATEX SURGEON'S GLOVE (K052031)Shun Thai Rubber Gloves Industry Public Co., Ltd.2005-09-12
COGNITRACE (K051825)Eemagine Medical Imaging Solutions GmbH2005-09-12
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION (K052302)Boston Scientific Corp2005-09-12
VCS S3Y (K051130)Cycling and Health Tech. Industry R&D Center/Chc2005-09-09
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS (K051614)Lifecore Biomedical, Inc.2005-09-09
MULTIWAVE XR (K051876)Pacific Quantum Instruments, Inc.2005-09-09
Z-CHAIR (K052353)Pride Mobility Products Corp.2005-09-09
ALL PURPOSE CUFF, MODEL 222APC (K051904)Suntech Medical, Inc.2005-09-09
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES (K051269)Radiant Innovation, Inc.2005-09-09
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 (K051810)Scantibodies Laboratory, Inc.2005-09-09
SYNTHES VECTRA-T SYSTEM (K051665)Synthes Spine2005-09-09
I-PORT (K052389)Patton Medical Devices2005-09-09
BIS EEG MONITOR, MODEL A-3000 (K052362)Aspect Medical Systems, Inc.2005-09-09
TRU-SWAB STOCOCK (K052330)Medegen Medical Manufacturing Services2005-09-09
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (K041820)Ciba Vision Corporation2005-09-09
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (K052117)I-Flow Corp.2005-09-09
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 (K052375)Alilife Technological Co., Ltd.2005-09-09
SATELLITE SPINAL SYSTEM (K051320)Medtronic Sofamor Danek2005-09-09
SPINA SYSTEM (K033231)North American Medical Corp (Nam)2005-09-09
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A (K052305)Siemens Medical Solutions USA, Inc.2005-09-08
DR. OPPEL ST-501 (K051956)Sometech Incorporated2005-09-08
SOMATOM DEFINITION (K052216)Siemens Medical Systems, Inc.2005-09-08
MODIFICATION TO XIA SPINAL SYSTEM (K052181)Stryker Spine2005-09-08
VOLAR PLATE SYSTEM (K052150)Dvo Extremity Solutions, LLC2005-09-08
ZIVF-AIRE (K041952)Zander Medical Supplies, Inc.2005-09-08
LEGEND ALL-POLY CUP (K051407)Ortho Development Corp.2005-09-08
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC (K052154)Omron Healthcare, Inc.2005-09-08
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES (K051676)Mazor Surgical Technologies , Ltd.2005-09-08
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134)Philips Medical Systems2005-09-08
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL (K052153)Omron Healthcare, Inc.2005-09-08
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES (K052167)GE Healthcare2005-09-08
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650)Dade Behring, Inc.2005-09-08
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES (K051986)Synthes (Usa)2005-09-08
MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 (K052337)Eizo Nanao Corporation2005-09-08
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK (K051297)Roche Diagnostics Corp.2005-09-08
THE NEEDLE CATCHER (K051281)E.D.Medical , Ltd.2005-09-08
LEVITRONIX CENTRIMAG BACK-UP CONSOLE (K051209)Levitronix, LLC2005-09-08
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE (K052158)Welch Allyn, Inc.2005-09-08
SUPERDIMENSION/BRONCHUS 4.1 (K052260)Superdimension, Ltd.2005-09-08
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES (K052078)Philips Medical Systems Nederland B.V.2005-09-07
WHITTLESTONE EXPRESSER (K051112)Whittlestone, Inc.2005-09-07
NSTRAND IMPLANTATION KIT (K052024)North American Scientific, Inc.2005-09-07
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Every clearance here is in the API, with alerts when new ones post.