Atlas FDA

2012

3,135 FDA 510(k) clearances · Clearance year

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RecordFirmDate
U-RIGHT TD-1240 THERMOMETER (K113159)Taidoc Technology Corporation2012-01-06
RADIANCE (K112060)Gmv Aerospace and Defence S.A.2012-01-06
GLUCOSE TEST SYSTEM (K113137)Roche Diagnostics2012-01-06
IVAS 20MM (10 GAUGE) BALLOON CATHETER (K113477)Stryker Instruments, Instruments Div.2012-01-06
AVITA INFRARED THEROMETER WITH BLUETOOTH (K110559)Avita Corporation2012-01-06
SONOTT FLOWLAB(R) (K111730)Em-Tec GmbH2012-01-06
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE (K111861)Siemens Medical Systems USA2012-01-06
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER (K112301)Materialise NV2012-01-06
APTUS WRIST ARTHRODESIS PLATES (K112169)Medartis AG2012-01-06
TOUCHPACS SUITE (K112008)Touch Medical Solutions, Inc.2012-01-06
MIRAGE QUATTRO (K113127)Resmed, Ltd.2012-01-06
MTA ANGELUS (K112046)Angelus Industria DE Productos Odontologicos2012-01-06
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE (K111165)KARL STORZ Endoscopy-America, Inc.2012-01-06
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K112523)Siemens Healthcare Diagnostics, Inc.2012-01-06
APEX ARC HIP STEM (K113242)Omni Life Science, Inc.2012-01-05
VALET MICRO CATHETER (K112035)Volcano Corporation2012-01-05
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K112458)Medica-Rents Co., Ltd.2012-01-05
NMI 2.8 MICROCATHETER (K113638)Navilyst Medical, Inc.2012-01-05
STRYKER UNIVERSAL NEURO 3 SYSTEM (K112557)Stryker2012-01-05
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS (K113038)Smith & Nephew, Inc.2012-01-05
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955)Nova Biomedical Corporation2012-01-05
ELECTRO-GEL (K111717)Electro-Cap Intl., Inc.2012-01-05
PROMOS MODULAR SHOULDER SYSTEM (K113012)Smith & Nephew, Inc.2012-01-05
HALO60 ABLATION CATHETER (K112454)Barrx Medical, Inc.2012-01-05
DIGITAL X-RAY IMAGING SYSTEM (K111103)Rf Co., Ltd.2012-01-05
ORTHOSCAN MOBILE DI MINI C-ARM (K113708)Orthoscan, Inc.2012-01-05
FOCUS MIS SYSTEM (K112643)L&K BIOMED Co., Ltd.2012-01-04
CERTUS 140 2.45GHZ ABLATION SYSTEM (K113237)Neuwave Medical, Inc.2012-01-04
DYNA LOCKING CANNULATED SCREW (K112240)U&I Corp.2012-01-04
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL (K113211)Instrumentation Laboratory CO2012-01-04
DNE EXTERNAL FIXATION SYSTEM (K113106)Dne, LLC2012-01-04
AVIVO MOBILE PATIENT MANAGEMENT (K113187)Corventis, Inc.2012-01-04
NORMATEC MVP (K112890)NormaTec Industries, LP2012-01-04
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 (K113609)Exactech, Inc.2012-01-04
BIGBOSS CATHETER (K113589)Bridgepoint Medical2012-01-04
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Every clearance here is in the API, with alerts when new ones post.