Atlas FDA

2012

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

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RecordFirmDate
SYNGO RT INTERFACE (K120363)Siemens Medical Solutions USA, Inc.2012-03-20
NEWDEAL INTERPHALANGEAL IMPLANT (K103623)Newdeal Sas2012-03-20
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM (K113475)Endoscopic Technologies, Inc. D/B/A Estech2012-03-20
BIOBOLT (K120540)Arthrex, Inc.2012-03-20
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER (K112100)Vascular Solutions, Inc.2012-03-20
MAMMOTOME ELITE BIOPSY SYSTEM (K112411)Devicor Medical Products, Inc.2012-03-20
V1 SYSTEM (K111756)Olympus Medical Systems Corp.2012-03-20
PIPELINE CR PRIMARY KNEE SYSTEM (K113122)Pipeline Orthopedics2012-03-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110536)Zibo Tengyue Plastic Products Co., Ltd.2012-03-19
PLEURX PERITONEAL CATHETER SYSTEM (K113854)Care Fusion2012-03-19
CLEARCORRECT SYSTEM (K113618)Clearcorrect, Inc.2012-03-19
HIVOX BIOTEK INC. (K112392)Hivox Biotek, Inc.2012-03-19
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) (K112078)Maruchi2012-03-19
METHA HIP SYSTEM (K112682)Aesculap Implant Systems, LLC2012-03-19
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN (K120544)St Jude Medical2012-03-19
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR (K112268)Codan US Corp.2012-03-19
FILTEK BULK FILL FLOWABLE RESTORATIVE (K120453)3M Espe Dental Products2012-03-19
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 (K120557)Biomet Spine & Bone Healing Technologies2012-03-19
ABL90 FLEX (K120197)Radiometer Medical Aps2012-03-19
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) (K113808)C.R. Bard, Inc.2012-03-19
CHESAPEAKE SPINAL SYSTEM (K120031)K2m, Inc.2012-03-16
E-CUBE 9 (K120060)Alpinion Medical Systems Co., Ltd.2012-03-16
RNARETAIN (K113420)Asuragen, Inc.2012-03-16
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE (K113763)Nobles Medical Technologies Ii, Inc.2012-03-16
UNIVERSAL MAXILLARY MOLAR (K110337)Oco Biomedical2012-03-16
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) (K113239)Health & Life Co., Ltd.2012-03-16
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K113811)C.R. Bard Inc., Bard Electrophysiology Division2012-03-16
DEFLEX ACRILATO (K113788)Nuxen S.R.L.2012-03-16
ENDO-EXPRESS (R) HANDPIECE (K111541)Essential Dental Systems, Inc.2012-03-16
BD BACTEC Plus Aerobic/F Culture Vials (plastic) (K113558)Becton, Dickinson and Company2012-03-16
HORIZON CARDIOLOGY ECG MANAGEMENT (K113515)Mckesson Israel , Ltd.2012-03-16
INSORB ABSORBALBE STAPLE (K120373)Incisive Surgical, Inc.2012-03-16
GORE(R) EMBOLIC FILTER (K120480)W.L. Gore & Associates2012-03-16
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN (K113766)Varian Medical Systems, Inc.2012-03-16
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P (K120485)Nihon Kohden America, Inc.2012-03-16
ELECTROCARDIOGRAPH (K120188)Edan Instruments, Inc.2012-03-16
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 (K113320)Exactech, Inc.2012-03-16
1.5T GEM FLEX COIL (K113474)Neocoil, LLC2012-03-16
FEMTO LDV (K112154)Sie Ag,Surgical Instument Engineering2012-03-16
NUVASIVE NVM5 SYSTEM (K112718)Nuvasive, Inc.2012-03-16
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (K112998)Zoll Circulation2012-03-15
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 (K111933)Covidien2012-03-15
CAREFUSION NICOLET EDX (K112052)Carefusion 209, Inc.2012-03-15
B-GENIN, R-GENIN (K113791)Berkeley Advanced Biomaterials, Inc.2012-03-15
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH (K120120)Aga Medical Corporation2012-03-15
ENDOSCOPIC APPLICATOR (K120608)Micromedics, Inc.2012-03-15
CITIEFFE TITANIUM NAILING SYSTEM (K113387)Citieffe2012-03-15
IM-11 PNEUMATIC MICROINJECTOR (K113712)Narishige Co., Ltd.2012-03-15
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) (K120677)Trireme Medical, Inc.2012-03-15
LEVEEN SUPERSLIM NEEDLE ELECTRODE (K113090)Boston Scientific Corporation2012-03-15
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR (K113749)Full Synergy Medical Products, Inc.2012-03-15
CONQUEST 40 PTA DILATATION CATHETER (K120660)Bard Peripheral Vascular, Inc.2012-03-15
QUIDEL MOLECULAR INFLUENZA A+B (K113777)Quidel Corp.2012-03-15
CONCENTRIC BALLOON GUIDE CATHETER (K112404)Concentric Medical, Inc.2012-03-15
FOUNDATION SPINAL SYSTEM (K120074)The Skeletal Design Partnership , Ltd.2012-03-14
ENFLOW IV FLUID WARMER (K112902)Vital Signs, Inc.2012-03-14
VIAVALVE SAFETY IV CATHETER (K113700)Smiths Medical Asd, Inc.2012-03-14
AIR-BAG SYSTEM (K112969)Niigata Mechatronics Co., Ltd.2012-03-14
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM (K102189)Latexx Manufacturing Sdn.Bhd.2012-03-14
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE (K111820)Bm Korea Co., Ltd.2012-03-14
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA (K113756)Encore Medical L.P.2012-03-14
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439)Bio-Rad Laboratories, Inc.2012-03-14
ORTHOSIZE (K120115)Orthosize, LLC2012-03-14
VETA PERITONEAL DIALYSIS CATHETER (K113354)Pfm Medical, Inc.2012-03-13
AILERON INTERSPINOUS FIXATION SYSTEM (K113157)Life Spine2012-03-13
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS (K112144)Tornier2012-03-13
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM (K113688)Biolitec Medical Devices, Inc.2012-03-13
OSTEOCOOL (TM) RF ABLATION SYSTEM (K111523)Baylis Medical Co., Inc.2012-03-13
NUVASIVE COROENT NO-PROFILE SYSTEM (K112561)Nuvasive, Inc.2012-03-13
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION (K103329)Delbio Incorporation2012-03-13
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM (K103116)Bestgen Biotech Corp.2012-03-13
ASFORA BULLET CAGE (K112648)Medical Designs, LLC2012-03-13
WILDCAT CATHETER (K113838)Avinger, Inc.2012-03-12
RELIANCE LUMBAR IBF SYSTEM (K113540)Reliance Medical Systems, LLC2012-03-12
VISUAL-ICE CRYOABLATION SYSTEM (K113860)Galil Medical, Inc.2012-03-12
ADAPTIVE WEDGE (K110662)Adaptive Specialty, LLC2012-03-12
PIONEER POSTERIOR CERVICO THORACIC SYSTEM (K112757)Pioneer Surgical Technology, Inc.2012-03-12
TRAUMA INTERNAL FIXATION SYSTEMS (K111663)DePuy Orthopaedics, Inc.2012-03-12
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL (K112663)Enhatch Orthopaedics, LLC2012-03-12
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST (K113624)Guangzhou Wondfo Biotech Co., Ltd.2012-03-12
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER (K113429)Nipro Medical Corporation2012-03-12
MICT TSH (K110761)Magnabiosciences, LLC2012-03-09
SATURN 8000 (K120380)New Medical Co., Ltd.2012-03-09
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS (K112638)Nova Biomedical Corporation2012-03-09
PIPELINE TOTAL HIP SYSTEM (K112802)Pipeline Orthopedics2012-03-09
QLAB QUANTIFICATION SOFTWARE (K120525)Philips Healthcare Group2012-03-09
HBIDB - HUMAN BRIAN INDEX SOFTWARE (K112077)Corscience GmbH & Co. KG2012-03-09
HEMO-CATH 10F, HEMO-CATH 12.5F (K113487)Medical Components, Inc.2012-03-09
SURGICAL RETRACTORS (K112659)Surgical Innovations Plc2012-03-09
LANX SPINAL FIXATION SYSTEM (K120399)Lanx, LLC2012-03-09
ASCEND SHOULDER SYSTEM (K113413)Tornier, Inc.2012-03-09
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (K113423)Kimberly-Clark Corp.2012-03-09
MODIFIED CONCENTIRC MICROCATHETER (K113260)Concentric Medical, Inc.2012-03-09
SYNCHRONY RESPIRATORY TRACKING SYSTEM (K120233)Accuray Incorporated2012-03-09
YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR (K120526)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2012-03-08
IFS LASER SYSTEM (K113151)Abbott Medical Optics, Inc.2012-03-08
POWER ADAPTOR INSTRUMENT ACCESSORY (K120434)Stryker Corp.2012-03-08
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES (K113810)Alma Lasers, Inc.2012-03-08
LIASYS 450 (K113131)Ams2012-03-08
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED (K120044)Arthrex, Inc.2012-03-08
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Every clearance here is in the API, with alerts when new ones post.