Atlas FDA

2011

3,124 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TRANS1 AXIALIF PLUS (K102334)Trans1 Incorporated2011-03-14
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM (K103156)Kci USA, Inc. (Kinetic Concepts, Inc.)2011-03-14
SILVER ANTIMICROBIAL WOUND GEL (K110458)Advanced Medical Solutions Limited2011-03-14
OSSPRAY SYLC CR (K103114)Osspray, Ltd.2011-03-14
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 (K101552)Foshan Care Medical Technology Co., Ltd.2011-03-14
ECHO BLASTER (K102253)Telemed2011-03-14
NEWFIX EXTERNAL FIXATION SYSTEM (K101338)Technologia Y Diseno Industrial, S.A DE C.V2011-03-14
STCC (K100698)Cardinal Spine, LLC2011-03-14
STEALTH 360 ORBITAL PAD SYSTEM (K110389)Cardiovascular Systems, Inc.2011-03-11
NP15 (K102515)Weinmann Gerate Fur Medizin GmbH + Co. KG2011-03-11
MERIT EMBOLECTOMY CATHETER MODEL ASAP100 (K100569)Merit Medical Systems, Inc.2011-03-11
LINA XCISE MODEL MOR-1515 (K101458)Lina Medical Aps2011-03-11
FUKUDA DENSHI (K103134)Fukuda Denshi USA, Inc.2011-03-11
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS (K101607)Biomet 3i, Inc.2011-03-11
AIDA DIAGNOSTIC ULTRASOUND SYSTEM (K103148)Panasonic Healthcare Co., Ltd.2011-03-11
COUDE/ OR TIEMANN (K103371)Degania Silicone , Ltd.2011-03-11
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO (K102692)Hangzhou Jincheng Medical Supplier Manufacture Co.2011-03-11
HEAD FIATION DEVICE (HFD 100) (K103493)Imris, Inc.2011-03-11
E4D COMPASS (K110511)D4D Technologies2011-03-11
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP (K110343)Mayborn Baby and Child / Jackel International, Ltd.2011-03-11
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD (K103712)Depuy Mitek, A Johnson & Johnson Company2011-03-11
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE (K102919)Maquet Cardiopulmonary, AG2011-03-11
STELLAR 300 (K103763)Larsen & Toubro Limited2011-03-11
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS (K101608)Biomet 3i, Inc.2011-03-11
CIV-OB (PLUS) (K103172)Civnet Communication, Ltd.2011-03-11
DISCOVRED (K102821)Phoenix Dental, Inc.2011-03-11
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM (K101913)Anthogyr Sas2011-03-11
COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102102)VATECH Co., Ltd.2011-03-11
ISOGRAY TREATMENT PLANNING SYSTEM (K103146)Dosisoft SA2011-03-11
VERIFY 270FP CHALLENGE PACK (K103053)STERIS Corporation2011-03-10
CERACELL DENTAL (K103709)Curasan AG2011-03-10
AIRSTRIP REMOTE PATIENT MONITORING (RPM) (K110503)Airstrip Technologies, LP2011-03-10
NOVEL TAPERED HIP STEM (K103479)Stryker Corp.2011-03-10
DYSIS (K092433)Forth Photonics Hellas SA2011-03-10
EASY CUFF (K102704)Joan Spiegel, MD2011-03-10
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) (K103123)Micro-Mega Societe Anonyme2011-03-10
ET III SA ULTRA WIDE SYSTEM (K103537)Hiossen, Inc.2011-03-10
DEPUY CORAIL HIP SYSTEM, REVISION STEM (K093736)DePuy Orthopaedics, Inc.2011-03-10
VOLUSON S6, VOLUSON S8 (K103649)GE Healthcare2011-03-09
TRINITY ACETABULAR SYSTEM (K103518)Corin USA2011-03-09
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110361)Zoll Medical Corporation, World Wide Headquarters2011-03-08
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING (K103191)Maquet Cardiopulmonary, AG2011-03-08
IPL THERAPY SYSTEM (K101901)Beijing Starlight Science & Technology Development2011-03-08
SYMMETRIC TOTAL KNEE AGUMENTS (K100370)Signal Medical Corp.2011-03-07
GEM OPTION FOR 1.5 MRI SYSTEMS (K103335)GE Healthcare2011-03-07
EU-TTG IGA AND EU-TTG IGG (K102964)Grifols USA, Inc.2011-03-07
BD FACS SAMPLE PREP ASSISTANT III (SPA III) (K102064)Becton, Dickinson & CO2011-03-07
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES (K101250)Given Imaging , Ltd.2011-03-07
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 (K101854)Siemens Healthcare Diagnostics2011-03-07
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP (K103400)Stryker Corporation2011-03-07
THORACIC VCAR (K103480)Ge Medical Systems, LLC2011-03-07
MICRO DIARY SPIROMETER (K100928)Viasys Respiratory Care, Inc.2011-03-07
PALLA M SPINAL SYSTEM (K102574)Korea Bone Bank Co., Ltd.2011-03-07
QUANTUM SPINAL SYSTEM, QUANTUM MIS (K101790)Pioneer Surgical Technology2011-03-07
ASAHI GUIDE WIRE EXTENSION 165CM (K101985)Asahi Intecc Co., Ltd.2011-03-07
ALEUTTIAN (K103169)K2m, Inc.2011-03-07
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO (K102642)Sonoscape Company Limited2011-03-04
EZ-MISTER (K093584)N.M. Beale Co., Inc.2011-03-04
FOCUS EMG DEVICE (K102610)Teleemg, LLC USA2011-03-04
PARIETEX PROGRIP (K103682)Sofradim Production2011-03-04
STERRAD 100NX STERILIZER EXPRESS CYCLE (K092622)Advanced Sterilization Products2011-03-04
SYNAPSE 3D CEREBRAL ANALYSIS (K103687)Fujifilm Medical System U.S.A., Inc.2011-03-04
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) (K102320)Daesung Maref Co., Ltd.2011-03-04
TRIO TRAUMA SPINAL SYSTEM (K103292)Stryker Corporation2011-03-04
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR (K110145)Biomet, Inc.2011-03-04
FLAATZ 750E (K102474)Drtech Corp.2011-03-04
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM (K110354)Synthes USA2011-03-04
OLECRA INTRAMEDULLARY FIXATION SYSTEM (K110322)Mylad Orthopedic Solutions2011-03-04
BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP (K103585)Harry J. Bosworth Co.2011-03-04
RAUMEDIC- ICP-MONITORING SYSTEM (K103206)Raumedic AG2011-03-04
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W (K110393)Ekf-Diagnostic GmbH2011-03-04
SOMATOM DEFINITION AS (K103127)Siemens Medical Solutions USA, Inc.2011-03-04
PULMOTRACK 2020 SYSTEM (K102229)Karmelsonix2011-03-04
VIEWPOINT 6 (K103458)GE Healthcare2011-03-04
CERAMIC FEMORAL HEAD (K103497)United Orthopedic Corp.2011-03-04
BARCO MAMMO TOMOSYNTHESIS (K103792)Barco N.V.2011-03-04
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING (K102464)Maquet Cardiopulmonary, AG2011-03-04
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE (K093830)Medline Industries, Inc.2011-03-03
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES (K102554)Avita Corporation2011-03-03
AXIS PACS, HMS PACS (K103679)Axis Health Care, LLC2011-03-03
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K110295)Boston Scientific Corp2011-03-03
PERMOBIL M300 / M400 (K103477)Permobil AB2011-03-03
SPACELABS MULTI-PARAMETER MODULE (K103142)Spacelabs Healthcare, Inc.2011-03-03
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (K102403)Sam Medical Products2011-03-03
NUVASIVE TRAVERSE PLATE SYSTEM (K103750)Nuvasive, Inc.2011-03-03
ZENITH PEDICLE SYSTEM (K102636)Apollo Spine, Inc.2011-03-03
RESTORATION ACETABULAR WEDGE AUGMENTS (K102019)Howmedica Osteonics2011-03-03
INTERLOCK FIBERED IDC OCCLUSION SYSTEM (K102912)Boston Scientific2011-03-03
VANGUARD REMOVABLE MOLDED POLY TIBIA (K102580)Biomet Manufacturing Corp2011-03-03
TROPHON CHEMICAL INDICATOR (K103126)Nanosonics Limited2011-03-03
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES (K101820)Yty Industry (Manjung) Sdn Bhd2011-03-03
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (K103002)Synthes (Usa)2011-03-02
LAGUNA PEDICLE SCREW SYSTEM (K103748)Phygen, LLC2011-03-02
SPAULDING IQ ELECTROCARDIOGRAPH (K110065)Spaulding Clinical Research, LLC2011-03-02
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION (K101850)Spacelabs Healthcare, Ltd.2011-03-02
SURGISURE TISSUE REMOVAL SYSTEM (K103741)Interlace Medical, Inc.2011-03-02
INPECTRA STO2 SPOT CHECK (K103613)Hutchinson Technology, Inc.2011-03-02
CONCORDE BULLET CAGE SYSTEM (K103488)Johnson and Johnson2011-03-02
BLOOD PRESSURE CUFF (K102825)APK Technology Co., Ltd.2011-03-02
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (K110456)Pharmajet, Inc.2011-03-02
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Every clearance here is in the API, with alerts when new ones post.