Atlas FDA

2013

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

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RecordFirmDate
SPECULAR MICROSCOPE CEM-530 (K130565)Nidek Co., Ltd.2013-11-27
ZIP MIS INTERSPINOUS FUSION SYSTEM (K133091)Aurora Spine2013-11-27
GENESIS LED WANDS (K131142)Genesis Biosystems, Inc.2013-11-27
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM (K133329)Samsung Medison Co., Ltd.2013-11-27
JUSHA-M52C MEDICAL DISPLAY (K131390)Nanjing Jusha Display Technology Co., Ltd.2013-11-27
ARCHON ANTERIOR CERVICAL PLATE SYSTEM (K131025)Nuvasive, Inc.2013-11-27
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) (K131591)Pega Medical, Inc.2013-11-27
ROGS (K131016)Molecular Products , Ltd.2013-11-27
E-CUBE 7 (K132687)Alpinion Medical Systems Co., Ltd.2013-11-27
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM (K133282)Reverse Medical Corporation2013-11-27
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS (K132658)Teleflex Medical2013-11-27
MYLABSEVEN, MYLABALPHA (K132231)Esaote, S.p.A.2013-11-27
SHASER V-MINI RX (K132170)Shaser, Inc.2013-11-26
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC (K131913)Philips Medizin Systeme Boeblingen GmbH2013-11-26
KNIT-PAK+ (K132526)Premier Dental Products Co.2013-11-26
NEWTRON BOOSTER (K131997)Satelec - Acteon Group2013-11-26
BD MAX STAPHSR ASSAY, INSTRUMENT (K132822)Geneohm Sciences Canada, Inc. (Bd Diagnostics)2013-11-26
TRIATHLON TRITANIUM METAL-BACKED PATELLA (K132624)Stryker Orthopaedics2013-11-26
DISPOSABLE INFUSION SET (K131646)Shanghai Jinta Medical Co., Ltd.2013-11-26
PRODIGY CHOICE (K122340)Prodigy Diabetes Care, LLC2013-11-26
EMOTION ECG MOBILE (K131699)Mega Electronics , Ltd.2013-11-26
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298)Exactech, Inc.2013-11-26
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (K131369)KARL STORZ Endoscopy-America, Inc.2013-11-26
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN (K133330)Roche Diagnostics2013-11-26
SOLAX (K131302)Dongguan Prestige Sporting Goods Co., Ltd.2013-11-26
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM (K132740)Spinefrontier, Inc.2013-11-26
STERITEC GREEN CARD PACK BOWIE-DICK TEST (K132372)Steritec Products Mfg Co, Inc.2013-11-26
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) (K132699)Tyrx, Inc.2013-11-26
SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR (K122024)Spsmedical Supply Corp.2013-11-26
ASPIRE RX-LP6 ASPIRATION CATHETER (K131998)Control Medical Technology, LLC2013-11-26
CYBERWAND STERILE PROBE SET (K132795)Cybersonics, Inc.2013-11-26
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR (K131828)Jiangsu Handsafe Glove Co., Ltd.2013-11-26
NEURODYN MULTIWAVE, AUSSIE SPORT (K131629)Ibramed Equipamentos Medicos2013-11-26
CV3000 HOLTER ANALYSIS SYSTEM (K131897)Vales & Hills Biomedical Tech. , Ltd.2013-11-26
CHARRUAPACS SYSTEM (K133357)Charruasoft SA2013-11-25
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM (K132504)Corelink, LLC2013-11-25
DANA REUSABLE BI TEST PACK (K130135)Dana Products, Inc.2013-11-25
ANAX 5.5 SPINAL SYSTEM (K132101)U&I Corporation2013-11-25
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA (K132544)Tomtec Imaging Systems GmbH2013-11-25
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE (K132029)Spinal USA2013-11-25
INBODY (K130777)Biospace Corporation Limited2013-11-25
CD HORIZON SPINAL SYSTEM (K132639)Medtronic Sofamor Danek USA, Inc.2013-11-25
CAPNOMASK (K131339)Mediplus , Ltd.2013-11-25
ARTHREX COMPRESSION FT SCREWS (K132217)Arthrex, Inc.2013-11-25
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM (K132884)Zimmer Spine, Inc.2013-11-25
VALVED TEARAWAY INTRODUCER GENERATION II (K132498)Medcomp (Medical Components, Inc.)2013-11-25
FDR D-EVO FLAT PANEL DETECTOR SYSTEM (K132509)Fujifilm Medical Systems U.S.A, Inc.2013-11-25
BIA / VITALITY ANALYZER (K130856)Ipgdx, LLC2013-11-25
BLACK COLOURED CONDOM (K132597)Karex Industries Sdn. Bhd.2013-11-25
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133399)Cardiovascular Systems Incorporated2013-11-22
CRESCENT SPINAL SYSTEM (K133216)Medtronic Sofamor Danek, Inc.2013-11-22
PC ECG (K131819)Edan Instruments, Inc.2013-11-22
EASYCARE ONLINE (K132371)Resmed, Ltd.2013-11-22
MAGNETOM PRISMA, MAGNETOM PRISMA FIT (K132119)Siemens Medical Solutions USA, Inc.2013-11-22
ELECSYS CK-MB CALCHECK 5 (K133284)Roche Diagnostics2013-11-22
REDSENSE ALARM SYSTEM (K130554)Redsense Medical AB2013-11-22
CLARITY LPC LASER SYSTEM (K130199)Lutronic Corporation2013-11-22
ADHESIVE ELECTRODES (K132588)Top-Rank Health Care Equipment Co., Ltd.2013-11-22
V-STICK VASCULAR ACCESS SET (K130730)Argon Medical2013-11-22
BREATH SHAKE (K121587)Cheen Houng Ent. Co. , Ltd.2013-11-22
OTOMAG BONE CONDUCATION HEARING SYSTEM (K132189)Sophono, Inc.2013-11-22
SENSE-4BABY SYSTEM (K132918)Sense4baby , Inc.2013-11-22
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM (K123090)General Life Biotechnology Co., Ltd.2013-11-22
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067)Siemens Healthcare Diagnostics, Inc.2013-11-22
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING (K131826)Jiangsu Toptouch Glove Co., Ltd.2013-11-22
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER (K132288)I-Sens, Inc.2013-11-22
PIEZON 150 (K132443)E.M.S Electro Medical Systems S.A2013-11-22
VIRTUOSO SYSTEM FOR IHC ER (SPI) (K130515)Ventana Medical Systems, Inc.2013-11-22
V8 TRANSLUMINAL BAV CATHETER (K132728)Intervalve, Inc.2013-11-22
SP-FIX SPINOUS PROCESS FIXATION PLATE (K132191)Globus Medical, Inc.2013-11-22
SOFIA DISTAL ACCESS CATHETER (K131482)MicroVention, Inc.2013-11-22
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE (K132306)Persyst Development Corp.2013-11-21
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT (K130514)Audifon-USA, Inc.2013-11-21
INFLAMMA DRY (K132066)Rapid Pathogen Screening, Inc.2013-11-21
MALDI BIOTYPER CA (MBT-CA) SYSTEM (K130831)Bruker Daltonics, Inc.2013-11-21
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (K123977)Randox Laboratories, Ltd.2013-11-21
AGAMATRIX HEALTH MANAGER (K132821)Agamatrix, Inc.2013-11-20
BRONCHOSCOPY ELBOW (K132168)Respironics, Inc.2013-11-20
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, (K133008)Beacon Endoscopic2013-11-20
MONACO (K132971)Impac Medical Systems, Inc.2013-11-20
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR (K132808)Welch Allyn, Inc.2013-11-20
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE (K130212)Wuxi Yushou Medical Applicances Co., Ltd.2013-11-20
MULTICAM 3000 ECO (K132347)Inter Medical Medizintechnik GmbH2013-11-20
I2C (K132847)Ion Beam Applications S.A.2013-11-20
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES (K130230)Wuxi Yushou Medical Applicances Co., Ltd.2013-11-20
WRIGHT GRADIENT 52 - TORSO (K131387)Wright Therapy Products, Inc.2013-11-20
RETROARC RETROPUBIC SLING SYSTEM (K132655)American Medical Systems, Inc.2013-11-20
NMI PICC III (K133264)Navilyst Medical, Inc.2013-11-20
APEX SPINE SYSTEM (K132603)Spinecraft, LLC2013-11-20
AFFIX II SPINOUS PROCESS PLATE SYSTEM (K132411)Nu Vasive, Incorporated2013-11-20
MRI MARKER (K131689)C4 Imaging, LLC2013-11-20
ISIRONA MAGELLAN (K130707)Isirona, LLC2013-11-20
EVEREST SPINAL SYSTEM (K132757)K2m, Inc.2013-11-20
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW (K132893)Icon Orthopaedic Concepts Dba Edge Orthopaedics2013-11-20
HAMILTON-MR1 (K122438)Hamilton Medical AG2013-11-20
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER (K132712)Medtronic, Inc.2013-11-19
MISEQDX UNIVERSAL KIT 1.0 (DEN130042)Illumina, Inc.2013-11-19
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM (K132779)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-11-19
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (K131377)Arthrosurface, Inc.2013-11-19
SUMITOMO PROTON THERAPY SYSTEM (K130426)Sumitomo Heavy Industries, Ltd.2013-11-19
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Every clearance here is in the API, with alerts when new ones post.