Atlas FDA

2017

3,200 FDA 510(k) clearances · Clearance year

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RecordFirmDate
3M Comply Hydrogen Peroxide Indicator Tape (K170563)3M Company2017-07-27
TIGR Matrix Surgical Mesh (K163005)Novus Scientific AB2017-07-27
Fully Automatic Blood Pressure Monitor (K171282)Andon Health Co, Ltd.2017-07-27
ARIX Ankle Distal Tibia System (K170313)Jeil Medical Corporation2017-07-27
SML-OSA2 Appliances (K162816)Selane Products, Inc.2017-07-27
FETAL PILLOW (DEN150053)Safe Obstetric Systems, Ltd.2017-07-27
Nasal Alar SpO2 Sensor (K171423)Xhale, Inc.2017-07-27
truFreeze System (K172041)CSA Medical, Inc.2017-07-27
VacLok AT Vacuum Syringe (K163597)Merit Medical Systems, Inc.2017-07-27
Bunegin-Albin Air Aspiration Set (K163031)Cook Incorporated2017-07-27
VISCO 360 Viscosurgical System (K171905)Sight Sciences, Inc.2017-07-27
wireless thermometer (K170769)Ech (Changzhou) Medical Instrument Co., Ltd.2017-07-26
NHAC 16 (K171515)Lmt Medical Systems GmbH2017-07-26
Orbit Inserter (K163400)Ypsomed AG2017-07-26
BiopSee, Mobile US (K170841)Medcom GmbH2017-07-26
MagDen Dental Implant System (K162867)Shinhung Mst Co., Ltd.2017-07-26
HygePLUS Alginate Impression Material (K170812)Hygedent, Inc.2017-07-26
Hydrocleanse Antimicrobial Skin and Wound Care Solution (K171727)Sonoma Pharmaceuticals2017-07-26
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (K163536)Bruker Daltonik GmbH2017-07-26
PHMB Antimicrobial Foam Wound Dressing (K163062)Advanced Medical Solutions, Ltd.2017-07-25
CARTO 3 EP Navigation System, Version 6.0 and Accessories (K170600)Biosense Webster, Inc.2017-07-25
LightMed Dental Laser System (K170073)Lightmed Dentaltechnology Corp.2017-07-25
HP PRO Positioning Device (K171734)Orfit Industries NV2017-07-25
Monteris Medical NeuroBlate System (K171255)Monteris Medical, Inc.2017-07-25
Rubicon 14, 18 and 35 Support Catheters (K171913)Boston Scientific Corporation2017-07-25
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (K170997)Biosense Webster, Inc.2017-07-25
LumFuse-TP (K171630)Precifit Medical, Ltd.2017-07-25
CT Midline (K170770)Medical Components, Inc. (dba MedComp)2017-07-25
TomoTherapy Treatment Delivery System with iDMS (K171837)Accuray Incorporated2017-07-25
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (K171645)Strukmyer Medical2017-07-25
Spinal Manometer NRFit; Spinal Manometer LUER (K170305)PAJUNK GmbH Medizintechnologie2017-07-25
MagVita TMS Therapy System (K171967)Tonica Elektronik A/S2017-07-25
ANCHORMAN Tibial Ligament Fixation Device (K170388)Summit Medical , Ltd.2017-07-25
Radiance V4 (K171885)Gmv Soluciones Globales Internet S.A.U.2017-07-25
FTRD System Set (K170867)Ovesco Endoscopy AG2017-07-25
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color (K162312)Shen Wei USA, Inc.2017-07-25
Easyret (K170067)Quantel Medical2017-07-25
True Spinal Fixation System (K171559)Innovative Surgical Designs, Inc.2017-07-24
Custom Bars (K162633)Implant Direct Sybron Manufacturing, LLC2017-07-24
YELLOW 560 Fluorescence Module (K162991)Carl Zeiss Meditec, AG2017-07-24
MP LeFort I Plates (K171364)Stryker2017-07-24
DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates (K163486)Hnm Total Recon, LLC2017-07-24
Klassic HD® Hip System (K171962)Total Joint Othopedics, Inc.2017-07-24
Infant Transport Mattress Warmer with Disc (K163295)Rapid Aid Corp.2017-07-24
Rampart L Lumbar Interbody Fusion Device (K171724)Spineology, Inc.2017-07-24
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST (K162858)Careplus (M) Sdn Bhd2017-07-24
ARIX Diaphysis System (K171285)Jeil Medical Corporation2017-07-24
JAWS(TM) Nitinol Staple System (K170923)Paragon 282017-07-24
VITEK MS (K162950)bioMerieux, Inc.2017-07-22
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (K171441)Luminex Corporation2017-07-21
Vantage Elan 1.5T, V4.0 (K171597)Toshibamedical Systems Corporation2017-07-21
Ultimax-i, DREX-UI80 V1.60 (K170832)Toshibamedical Systems Corporation2017-07-21
True Form Reshapable Guide Wire (K170532)Merit Medical Systems, Inc.2017-07-21
Fujifilm Duodenoscope Model ED-530XT (K152257)Fujifilm Medical Systems U.S.A, Inc.2017-07-21
Vitrea View (K163232)Vital Images, Inc.2017-07-21
Teco Creatinine Enzymatic Reagent Kit (K161527)Teco Diagnostics, Inc.2017-07-21
External Moisturizing Gel (K171855)Combe Incorporated2017-07-21
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (K171753)Leica Biosystems Newcastle, Limited2017-07-21
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (K171003)3M Company2017-07-21
Progreat (K170223)Ashitaka Factory of Terumo Corporation2017-07-21
Portable Slit Lamp Microscope (K162778)Suzhou Kangjie Medical, Inc.2017-07-21
GelPOINT Path Transanal Access Platform (K171701)Applied Medical Resources Corp.2017-07-20
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color (K171616)Shandong Xingyu Gloves Co., Ltd.2017-07-20
DORA Disposable A.V. Fistula Needle Sets (K163025)Bain Medical Equipment (Guangzhou) Co., Ltd.2017-07-20
SIGN IM Nail (K163589)Sign Fracture Care International2017-07-20
Microlife Digital Infrared Ear Thermometer (K170219)Microlife Intellectual Property GmbH2017-07-20
dynaMX Intramedullary Implant (K170326)Arthrex, Inc.2017-07-20
CONCORDE LIFT (K171425)Medos International SARL2017-07-20
CADD® Infusion Disposables Portfolio with NRFit™ connectors (K162219)Smiths Medical Asd, Inc.2017-07-20
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System (K171439)Medos International SARL2017-07-20
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE (K171093)Sanrea Healthcare Products Pvt, Ltd.2017-07-19
CARDIOVIT FT-1 (K170182)Schiller AG2017-07-19
Mini Stick ENVI Non-Vascular Introducer Kit (K170775)AngioDynamics, Inc.2017-07-19
Disposable Standard Clamp (K170379)Standard Bariatrics2017-07-19
POD Packing Coil (K170852)Penumbra, Inc.2017-07-19
TiLock2 Spinal System (K171838)Genesys Spine2017-07-19
Dario Blood Glucose Monitoring System (K163159)Labstyle Innovations, Ltd.2017-07-19
Embrace Neonatal MRI System (K170978)Aspect Imaging, Ltd.2017-07-19
XPress BCD Breast Compression Device (K163388)Xpress Bcd, LLC2017-07-19
OLINDA EXM (K163687)Hermes Medical Solutions AB2017-07-19
QuantX (DEN170022)Quantitative Insights, Inc.2017-07-19
Nio Color 2MP (MDNC-2123) (K171812)Barco N.V.2017-07-19
Vela RX PTA Balloon Dilatation Catheter (K171290)Curatia Medical2017-07-19
Graftgun Universal Graft Delivery System (K170675)SurGenTec, LLC2017-07-19
MaxZero Extension Sets with Needless Connector (K171957)Carefusion 303, Inc.2017-07-19
Demi Ultra (K163064)Kerr Corporation2017-07-18
OSSIX BONE (K163714)Datum Dental, Ltd.2017-07-18
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (K162856)Bonart Co., Ltd.2017-07-18
ES2 Neuromonitoring Accessory Instruments (K171807)Stryker Corporation2017-07-18
Examion X-AQS (K170729)Examion GmbH2017-07-18
Arterys Viewer (K171544)Arterys, Inc.2017-07-18
Altrix Temperature Management Wraps (K171149)Stryker Medical2017-07-18
Faxitron Bioptics Speciemen Radiography System (K170786)Faxitron Bioptics, LLC2017-07-18
Inspire ICE aka Inspire ICE Clear Brackets (K171844)Ormco Corporation2017-07-18
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue (K162510)Ug Global Resources Sdn. Bhd.2017-07-18
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System (K171824)Edan Instruments, Inc.2017-07-18
CreoDent Solidex Customized Abutment and Screw (K170100)Creodent Prosthetics, Ltd.2017-07-18
20G x 5/8 Pro-Lock CT Safety Infusion Set (K171333)Medcomp (Dba Medical Components, Inc.)2017-07-18
JO Agapé Personal Lubricant (K171021)United Consortium2017-07-18
U2 Femoral Head (K162957)United Orthopedic Corporation2017-07-17
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Every clearance here is in the API, with alerts when new ones post.