Atlas FDA

2020

2,923 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Resoundant Acoustic Driver System (K201389)Resoundant, Inc.2020-07-10
DigitalDiagnost C50 (K201725)Philips Healthcare (Suzhou) Co., Lit.2020-07-10
Paragon 28 APEX 3D Total Ankle Replacement System (K192994)Paragon 28, Inc.2020-07-10
DreamStation 2 System, DreamStation 2 Advanced System (K200480)Respironics, Inc.2020-07-10
NextAR TKA Platform (K193559)Medacta Inernational SA2020-07-10
SmartLinx Vitals Plus Patient Monitoring System (K200856)Capsule Technologie Sas2020-07-10
Automatic Upper Arm Blood Pressure Monitor (K193624)Dongguan E-Test Technology Co., Ltd.2020-07-10
Disposable Specimen Retrieval Bag (K201243)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2020-07-10
HD Steth (K201299)Hd Medical, Inc.2020-07-10
Eclipse Treatment Planning System v16.1 (K201607)Varian Medical Systems, Inc.2020-07-10
ExcelsiusGPS Cranial 1.0 Module (K200047)Globus Medical, Inc.2020-07-10
X-Cube 90 (K200449)Alpinion Medical Systems Co., Ltd.2020-07-10
Sonicision Cordless Ultrasonic Dissector (K200427)Covidien, LLC2020-07-10
Infrascanner (K200203)Infrascan, Inc.2020-07-10
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System (K200568)B&J Manufacturing , Ltd.2020-07-10
AI-Rad Companion Engine (K193294)Siemens Medical Solutions USA, Inc.2020-07-10
ASSISTO Universal Applicator Clamping Device (K201279)Geomed Medizin-Technik GmbH & Co. KG2020-07-10
Ezra Plexo Software (K192969)Ezra Ai, Inc.2020-07-10
XACT Robotic System (K201586)Xact Robotics, Ltd.2020-07-09
SR-8100 Portable X-ray Unit (K200637)Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2020-07-09
i-Rapha Solution (K201296)Irm, Inc.2020-07-09
DuraDiagnost (K201640)Philips Healthcare (Suzhou) Co., Ltd.2020-07-09
Optiflux Enexa F500 Dialyzer (K192928)Fresenius Medical Care Reanal Therapies Group, LLC2020-07-09
GC Temp Print (K193113)GC America, Inc.2020-07-09
GTK Trocars (K193272)Guangzhou T.K Medical Instrument Co., Ltd.2020-07-09
Zimmer, Inc. Hip Joint Prostheses MR Labeling I (K200823)Zimmer, Inc.2020-07-09
Rapid LVO (K200941)Ischemaview, Inc.2020-07-09
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) (K200061)Galil Medical, Inc.2020-07-09
ETHICON Linx Esophagus Sizing Tool (K201035)Torax Medical, Inc.2020-07-09
B&J DVT Compression Devices MHH800/MHH800SQ (K200154)B&J Manufacturing , Ltd.2020-07-08
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955)Vascutek, Ltd.2020-07-08
Digital Thermometer (K200599)Joytech Healthcare Co. , Ltd.2020-07-08
Delta Multihole TT Pro Acetabular System (K200656)Lima Corporate S.P.A.2020-07-08
ACTIV.A.C. Negative Pressure Wound Therapy System (K201571)Kci USA, Inc.2020-07-08
VisCalor (K201307)Voco GmbH2020-07-08
Arthrex DynaNite Compression Plate (K193345)Arthrex, Inc.2020-07-08
CAPERE Thrombectomy System (K201216)Vascular Medcure, Inc.2020-07-08
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA (K200676)Zirkonzahn Srl2020-07-08
Intraosseous Fixation System (K201556)Extremity Medical, LLC2020-07-08
CMDR 2C (Multiple Models) (K201575)Minxray, Inc.2020-07-08
Dental Glass Ceramics Blocks (K192231)Aidite (Qinhuangdao) Technology Co., Ltd.2020-07-08
Looking Glass 4K Integrated Visualization System (K201593)Conmed Corporation2020-07-08
Arthrex Eclipse Shoulder Prosthesis System (K201542)Arthrex, Inc.2020-07-08
REXSIN (K200392)Sm Eng Co., Ltd.2020-07-07
uMR570 (K201540)Shanghai United Imaging Healthcare Co., Ltd.2020-07-06
Arthrex MaxForce MTP Compression Plates and Screws (K201235)Arthrex, Inc.2020-07-06
RC-Prime Root Canal Preparation Cream (K200330)Pac-Dent, Inc.2020-07-06
Deep Recon (K193073)Shanghai United Imaging Healthcare Co., Ltd.2020-07-06
MIS Ti-base Abutment (K191152)Dentsply Sirona2020-07-06
Fujifilm Ultrasonic Processor (K200850)Fujifilm Corporation2020-07-06
Lollipop BiteBlock (K200652)Radtec Medical Devices, Inc.2020-07-06
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (K200795)Medtronic, Inc.2020-07-03
Oxxiom (K200537)True Wearables, Inc.2020-07-03
VenaOne (K200285)Vena Group, LLC2020-07-02
IC-WHCD100 (Inspire) (K183471)Good Doctors Co., Ltd.2020-07-02
Traxcess 7 Mini Guidewire (K201487)MicroVention, Inc.2020-07-02
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ (K201599)Shenzhen Beacon Display Technology Co., Ltd.2020-07-02
Contour ProtegeAI (K193252)Mim Software, Inc.2020-07-02
InMode System with the Morhpeus8 Applicators (K200947)InMode , Ltd.2020-07-02
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (K192385)Ivwatch, LLC2020-07-02
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector (K200674)Atrility Medical, LLC2020-07-02
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (K193259)Little Doctor Electronic (Nantong)Co.,Ltd2020-07-02
Agape Cooling Personal Lubricant (K200894)CC Wellness, LLC2020-07-02
Terason uSmart 3200T Plus Ultrasound System (K201633)Teratech Corporation2020-07-02
GC Fuji Triage EP (K193484)GC America, Inc.2020-07-02
Luna XD Ti Interbody Fusion System (K193172)Benvenue Medical, Inc.2020-07-02
InferRead Lung CT.AI (K192880)Beijing Infervision Technology Co., Ltd.2020-07-02
ulrichINJECT CT Motion (K192872)Ulrich GmbH & Co. KG2020-07-02
Psoria-Shield AURORA (K192411)Psoria-Shield2020-07-02
3M Attest Steam Chemical Integrator Test Pack (K200766)3M Company2020-07-02
SherpaPak Pediatric Liver Transport System (K201048)Paragonix Technologies2020-07-02
StimPlus Patch, StimPlus Patch, StimPlus Patch (K200561)Jkh Health Co., Ltd.2020-07-01
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449)Medtronic, Inc.2020-07-01
Versana Premier (K200138)Ge Medical Systems Ultrasound And2020-07-01
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System (K200880)Stryker GmbH2020-07-01
syngo.via View&GO (K201477)Siemens Healthcare GmbH2020-07-01
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (K200248)Allwin Medical Devices, Inc.2020-07-01
Dental Electrical Motor iRoot Pro (K191276)Changzhou Bomedent Medical Technology Co.,Ltd2020-06-30
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End (K200874)Innovasis, Inc.2020-06-30
LassoStar Circular Mapping Catheter (K193632)Biosense Webster, Inc.2020-06-30
Kinos Axiom Total Ankle System (K192778)Kinos Medical2020-06-30
Altapore MIS (K201464)Baxter Healthcare Corporation2020-06-30
Litho 150, Cyber Ho 150 (K201455)Quanta System Spa2020-06-30
Surgical Drills (K200265)Implant Direct Sybron Manufacturing, LLC2020-06-30
Terragene Chemdye (K200272)Terragene S.A.2020-06-30
Cadence Total Ankle System (K201507)Integra LifeSciences Corporation2020-06-29
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K201423)Beckman Coulter, Inc.2020-06-29
Arthrex DynaNite K-Wire (K200068)Arthrex, Inc.2020-06-29
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green (K200420)Ethicon Endo-Surgery, LLC2020-06-29
Somnera System (K200698)Fresca Medical, Inc.2020-06-29
Electronic stimulator (K200354)Shenzhen Dongjilian Electronics Co., Ltd.2020-06-29
ARTIS pheno (VE2) (K201156)Siemens Medical Solution USA, Inc.2020-06-29
H500 Multi-Sensing Oximetry System (K192900)Nonin Medical, Inc.2020-06-29
Edge Air(1417) Digital Flat Panel X-ray Detector (K201503)Osko, Inc.2020-06-29
Twin-Pass Dual Access Catheter (K193119)Vascular Solutions, LLC2020-06-29
OMNIBotics Knee System (K200888)Corin, Ltd.2020-06-27
Ion Endoluminal System (K201146)Intuitive Surgical, Inc.2020-06-26
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (K201181)ABBOTT MEDICAL2020-06-26
Streamline Navigated Instruments (K200095)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2020-06-26
JDentalCare Implant System JDIcon (K182081)Jdentalcare Srl2020-06-26
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Every clearance here is in the API, with alerts when new ones post.