Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MAGSTIM DOUBLE 70-2 COIL (K130403)The Magstim Company , Ltd.2013-08-23
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM (K130244)Delbio Incorporation2013-08-23
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL (K131978)Biotronik, Inc.2013-08-23
TEMPUS(TM) CERVICAL PLATE SYSTEM (K131374)Neurostructures, LLC2013-08-23
ACCUSONIC ADVANTAGE (K124010)Metron Medical Australia, Pty, Ltd.2013-08-23
VANISHPOINT BLOOD COLLECTION SET (K122355)Retractable Technologies, Inc.2013-08-23
PRE-FORMED GUIDEWIRES (K130798)Lake Region Medical, Inc.2013-08-23
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER (K130137)Coltene/Whaledent2013-08-23
GYNECARE TVT EXACT CONTINENCE SYSTEM (K132054)ETHICON, Inc.2013-08-23
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K132268)Surgical Specialties Corporation Dba Angiotech2013-08-23
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM (K131878)Medyssey USA, Inc.2013-08-23
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY (K130268)Becton, Dickinson & CO2013-08-23
CARDIODAY (K130516)Getemed Medizin- Und Informationstechnik AG2013-08-23
AUTOBAND LIGATOR (K132535)Endochoice, Inc.2013-08-23
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) (K131581)Hologic, Inc.2013-08-22
PROGIGY SUPPORT CATHETER (K130714)Radius Medical, LLC2013-08-22
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) (K130301)Elimedical Devices (Fujian), Inc.2013-08-22
GIO DIGITAL PRESSURE GUAGES (K122627)Galemed Corp.2013-08-22
AVENIR CEMENTED HIP STEM (K131884)Zimmer GmbH2013-08-22
SIM (K130951)Simavita Pty Limited2013-08-22
SURGIQUEST AIRSEAL IFS (K132169)Surgiquest, Inc.2013-08-22
CRYOBALLOON FOCAL ABLATION SYSTEM (K131523)C2 Therapeutics2013-08-22
OPTI CCA-TS2 (K131126)Opti Medical Systems, Inc.2013-08-22
POWDERED VINYL EXAMINATION GLOVES (K122100)Wang Tong Xinghua Co., Ltd.2013-08-22
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS (K130076)Merz Dental GmbH2013-08-22
INSUFLOW SYNERGY XL PORT (K132204)Lexion Medical, LLC2013-08-22
SYMBOTEX(TM) COMPOSITE MESH (K131969)Sofradim Production2013-08-22
CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL (K131432)Kuraray Noritake Dental, Inc.2013-08-22
AERODR SYSTEM WITH P-31 (K130936)Konica Minolta Medical & Graphic, Inc.2013-08-22
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) (K131736)Hologic, Inc.2013-08-22
FLOWER SMALL AND MEDIUM IMPLANT SET (K131657)Flower Orthopedics Corporation2013-08-22
PALTOP DENTAL IMPLANT - STERILE ACCESSORIES (K131451)Paltop Advanced Dental Solutions, Ltd.2013-08-22
GMK FULL PE TIBIAL COMPONENTS (K131310)Medacta International2013-08-22
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS (K131707)3B Medical, Inc.2013-08-22
MOUNTAINEER OCT SPINAL SYSTEM (K132332)Medos International SARL2013-08-22
SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352)Sa Scientific , Ltd.2013-08-22
ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND (K132099)ArthroCare Corporation2013-08-22
DISPOSABLE NEUTRAL ELECTRODE GP202 (K130027)Cathay Manufacturing Corp.2013-08-22
LEGACY3 6MM LENGTH IMPLANTS (K131097)Implant Direct Sybron Manufacturing, LLC2013-08-22
WET PLATINUM PERSONAL LUBRICANT (K130012)Trigg Laboratories, Inc.2013-08-22
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 (K131085)Mespere Lifesciences, Inc.2013-08-22
3DVH (K131862)Sun Nuclear Corporation2013-08-21
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM (K132304)Philips Ultrasound, Inc.2013-08-21
IMDX FLU A/B AND RSV FOR ABBOTT M2000 (K131584)Intelligent Medical Devices, Inc.2013-08-21
CORVIEW (K131158)Marrek, Inc.2013-08-21
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM (K130696)I-Sens, Inc.2013-08-21
VITEK MS (DEN130013)bioMerieux, Inc.2013-08-21
SWING-OFF SCREW (K130627)Advanced Interventional Technology, LLC2013-08-21
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454)Physio-Control, Inc.2013-08-21
JUSHA-M32 MEDICAL DISPLAY (K131391)Nanjing Jusha Display Technology Co., Ltd.2013-08-21
STAXX IBL SYSTEM (K131071)Spine Wave, Inc.2013-08-20
SURESUBTRACTION ORTHO (K130960)Toshibamedical Systems Corporation2013-08-20
MULTILINK HYBRID ABUTMENT CEMENT (K130436)Ivoclar Vivadent, AG2013-08-20
KIMGUARD ONE STEP STERILIZATION WRAP (K113806)Kimberly-Clark Health Care2013-08-20
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (K122766)Microgenics Corp.2013-08-20
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM (K132228)Samsung Medison Co., Ltd.2013-08-20
CAS PSI SHOULDER (K131129)Zimmer Cas2013-08-20
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR (K130749)Siemens Medical Solutions USA, Inc.2013-08-20
GUARDIAN URETHRAL SHEATH (K131803)Solace Therapeutics2013-08-20
MAPCHECK2, ARCCHECK (K131466)Sun Nuclear Corporation2013-08-20
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (K131254)Kimberly-Clark Corp.2013-08-20
PAGODA PEDICLE SCREW SYSTEM (K131785)Ortho Development Corp.2013-08-20
STERICAN CANNULA (K131842)B.Braun Medical, Inc.2013-08-20
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (K123563)Magellan Diagnostics2013-08-20
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION (K132365)Accel Spine2013-08-20
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT (K131488)Alfa Wassermann Diagnostics Technologies, LLC2013-08-19
AXERA 2 ACCESS SYSTEM (K132263)Arstasis, Inc.2013-08-19
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET (K131687)Medical Components, Inc.2013-08-16
SMARTFLOW CATHETER (K123605)Mri Interventions, Inc.2013-08-16
INTELLIVUE PATIENT MONITOR (K131829)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013-08-16
ENDO E CLASS (K123608)Saeyang Microtech Co., Ltd.2013-08-16
QUICKIE & ZIPPIE SERIES (K123975)Sunrise Medical2013-08-16
QUATTRO GL SUTURE ANCHOR (K131325)Cayenne Medical, Inc.2013-08-16
VERIFY PROCESS INDICATOR FOR RELIANCE EPS (K130160)STERIS Corporation2013-08-16
ENDO A CLASS (K123582)Saeyang Microtech Co., Ltd.2013-08-16
PERF-GEN PULSATILE PERFUSION SOLUTION (K121736)Waters Medical Systems, LLC2013-08-16
SYMBIA (K131634)Siemens Medical Solutions USA, Inc.2013-08-16
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (K132334)Cook, Inc.2013-08-16
JIAJIAN CMN STIMULATOR (K130768)Wuxi Jiajian Medical Instrument Co., Ltd.2013-08-16
NEWA SKIN THERAPY SYSTEM (K130793)Endymion Medical, Ltd.2013-08-16
TRS CRANIAL BONE VOID FILLER(TRS C-BVF) (K123633)Tissue Regeneration Systems, Inc.2013-08-16
ABG III MONOLITHIC HIP STEM (K123604)Howmedica Osteonics Corp.2013-08-16
COVAGEN (K123756)Covalon Technologies, Ltd.2013-08-16
D-LUX (K130163)DiaDent Group International2013-08-16
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) (K131052)Actuated Medical, Inc.2013-08-16
INTERMITTENT PNEUMATIC COMPRESSION DEVICE (K123830)Dalian Labtek Science & Development Co., Ltd.2013-08-16
AMECO SHEATH INTRODUCER (K131144)Ameco Medical Industries2013-08-15
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN (K123766)Novo Nordisk, Inc.2013-08-15
CONTRAST CONSERVATION SYSTEM (K131478)Osprey Medical, Inc.2013-08-15
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (K131351)Alfa Wassermann Diagnostic Technologies, LLC2013-08-15
ORTHOVISION (K131570)Ewoosoft Co., Ltd.2013-08-15
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K132072)Nipro Diagnostics, Inc.2013-08-15
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM (K122181)Visgeneer, Inc.2013-08-15
ANYONETM INTERNAL IMPLANT SYSTEM (K123988)Megagen Implant Co., Ltd.2013-08-15
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS (K132341)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-08-15
DYNASENSE SYSTEM (K130752)Centauri Medical, Inc.2013-08-15
ORTHOHELIX STAPLE SYSTEM (K130832)Orthohelix Surgical Designs, Inc.2013-08-15
KINEX BIOACTIVE (K130392)Globus Medical, Inc.2013-08-15
LVIVO EF SYSTEM (K130779)Diacardio, Ltd.2013-08-15
GYMFORM ABS-A-ROUND (K130074)Well Brain International , Ltd.2013-08-15
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Every clearance here is in the API, with alerts when new ones post.