Atlas FDA

2021

3,023 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Surgical Mask (K202409)Allmed Medical Products Co., Ltd.2021-03-09
Nordiwell Surgical Face Mask (K210181)Changzhou Combat Protective Equipment Co., Ltd.2021-03-09
Blood Pressure Monitor (K202891)Guangdong Transtek Medical Electronics Co., Ltd.2021-03-09
Neodent EasyGuide Kit Cases (K203618)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-03-09
Disposable Medical Face Mask (K202710)Wanxinda (Guangzhou) Technology Product Co., Ltd.2021-03-09
Infrared Thermometer (K201508)Dongguan Prestige Sporting Goods Co., Ltd.2021-03-09
ZOLL Propaq M (K202375)ZOLL Medical Corporation2021-03-09
iCE-SG Subcutaneous Electrode Arrays (K201678)Ice Neurosystems, Inc.2021-03-08
Perfit ZR HT Dental Zirconia blank (K203351)Vatech Acucera, Inc.2021-03-08
Compressible Limb and Circulation Therapy System (K200660)Wonjin Mulsan Co., Ltd.2021-03-08
Disposable Medical Face Mask (K202439)Hunan Eexi Technology & Service Co., Ltd.2021-03-08
Versalock Periprosthetic Femur Plates System-GMReis (K201728)GM Dos Reis Industria e Comercio Ltda.2021-03-08
iHealth Wireless No-Touch Forehead Thermometer (K202753)Andon Health Co, Ltd.2021-03-08
Century Perfusion System (K202125)Century Hlm, LLC2021-03-07
Single-use medical face mask (K201974)Guangdong Horigen Mother & Baby Products Co., Ltd.2021-03-07
CPR BAND (K201581)Credo2021-03-06
Apex 3D Total Ankle Replacement System (K210390)Paragon 28, Inc.2021-03-06
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors (K202076)Shen Wei USA, Inc.2021-03-05
Cios Select (VA21) Flat Panel (K210309)Siemens Medical Solutions USA, Inc.2021-03-05
Akesis Galaxy RTi (K203146)Akesis, Inc.2021-03-05
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove (K202078)Shen Wei USA, Inc.2021-03-05
Vivid E80/ Vivid E90/ Vivid E95 (K202658)GE Medical Systems Ultrasound and Primary Care Diagnostics2021-03-05
NeuroCap (Model DEC22) (K202913)Memory MD, Inc.2021-03-05
Republic Spine Dark Star Spinal System (K201420)Republic Spine, LLC2021-03-05
Andorate Universal Endoscope Tip Guard (K202838)Ga Health Company Limited2021-03-05
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) (K191441)Maxstar Industrial Co., Ltd.2021-03-05
ClearUP Sinus Relief (DEN200006)Tivic Health Systems, Inc.2021-03-05
FlexSys (K203054)Gme German Medical Engineering GmbH2021-03-05
Surgical Mask (K203425)Bdc Dental Corporation , Ltd.2021-03-05
NeoWave Pain Relief and Recovery System, Model# T16-2020 (K202693)Eva Medtec, Inc.2021-03-05
SafeSept Blunt Needle (K210328)Pressure Products Medical Device Manufacturing, LLC2021-03-05
Reprocessed Inquiry Steerable Diagnostic EP Catheter (K203261)Innovative Health, LLC2021-03-05
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform (K202300)Optellum, Ltd.2021-03-05
InMode Evolve System with the Tone Applicator (K201285)InMode , Ltd.2021-03-05
OEC 3D (K203346)Ge Oec Medical Systems, Inc.2021-03-05
NuVision ICE Catheter (K201775)Nuvera Medical, Inc.2021-03-05
MI DeTACH (K210006)Biorep Technologies, Inc.2021-03-04
Cios Select (VA21) Image Intensifier (K210307)Siemens Medical Solutions USA, Inc.2021-03-04
Disposable medical mask (K202137)U-Play Products Corporation2021-03-04
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323)Canon Medical Systems Corporation2021-03-04
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation (K202018)Hill-Rom, Inc.2021-03-04
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ (K210019)Unimed Medical Supplies, Inc.2021-03-04
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 (K210324)Carefusion 2200, Inc.2021-03-04
BD Intraosseous Infusion System (K203193)Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]2021-03-04
Surgical Face Mask (K210225)Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.2021-03-04
AlignRT Plus (K203387)Vision Rt, Ltd.2021-03-04
AtriClip LAA Exclusion System (K210293)AtriCure, Inc.2021-03-03
WIRION Embolic Protection System (K210282)Cardiovascular Systems, Inc.2021-03-03
3M Attest Rapid Readout Biological Indicator, 1295 (K210277)3M Company2021-03-03
Ponto Bone Anchored Hearing System, MONO Surgery Kit (K203807)Oticon Medical AB2021-03-03
Promaxo MRI System (K202518)Promaxo, Inc.2021-03-03
Medical mask (Model: KKF-1A) (K202316)Han Zhaoqing Sporting Goods Company Limited2021-03-03
LOQTEQ Distal Lateral Femur Plate 4.5 System (K210043)Aap Implantate AG2021-03-03
Cultura Collection and Transport System (K201674)Merit Medical Systems, Inc.2021-03-03
Geistlich Mucograft®, Geistlich Mucograft® Seal (K210280)Geistlich Pharma AG2021-03-03
FineCross M3 (K203521)Ashitaka Factory of Terumo Corporation2021-03-03
EOGas 4 Endo-SteriTest RRBI (K202879)Andersen Sterilizers, Inc.2021-03-03
FORZA Ti Spacer System (K203576)Orthofix, Inc.2021-03-03
Biograph Vision Quadra PET/CT System (K210262)Siemens Medical Solutions USA, Inc.2021-03-03
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (K203764)Imperative Care, Inc.2021-03-03
Mars 1417X Wireless Digital Flat Panel Detector (K210316)Iray Technology Taicang , Ltd.2021-03-03
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System (K201965)CHISON Medical Technologies Co., Ltd.2021-03-02
Able Medical Devices Valkyrie Thoracic Fixation System (K202889)Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021-03-02
GMK Revision & Hinge Extension - TiNbN Coating (K210010)Medacta International S.A.2021-03-02
X-PLO2R (K203086)Belluscura, LLC2021-03-02
OverStitch Sx Endoscopic Suturing System (K210266)Apollo Endosurgery, Inc.2021-03-02
Mars1717X Wireless Digital Flat Panel Detector (K210314)Iray Technology Taicang , Ltd.2021-03-02
MaxFOV 2 (K203617)Ge Medical Systems, LLC2021-03-02
Ceragem Automatic Thermal Massager, Model CGM-MB-1901 (K202113)Ceragem Co., Ltd.2021-03-02
Surgical Mask-Model Number: Ear Loop, Flat-Pleated (K201852)Huizhou Foryou Medical Devices Co., Ltd.2021-03-02
Shoulder System - TiNbN Coating (K203755)Medacta International S.A.2021-03-02
MRI PPG Patient Cable (K203653)Ivy Biomedical Systems, Inc.2021-03-02
Arisure Closed System Drug Transfer Device (CSTD) (K201422)Yukon Medical, LLC2021-03-02
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) (K202356)Kanglongda Vietnam Protection Technology Company Limited2021-03-02
IFM Surgical Mask Model SM3 (K202214)Fssc, LLC2021-03-02
PleuraFlow System with FlowGlide (K203394)Clearflow, Inc.2021-03-02
Senhance Surgical System (K202166)Transenterix, Inc.2021-03-02
Fingertip pulse oximeter (K202776)Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.2021-03-01
Solitaire X Revascularization Device (K203358)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-03-01
imani i2 (K202037)Imani Co.2021-03-01
Med-Link Temp-pulse Oximeter (K202743)Shenzhen Med-Link Electronics Tech Co., Ltd.2021-03-01
OMNI Surgical System (K202678)Sight Sciences, Inc.2021-03-01
NuVasive Modulus ALIF System (K210271)Nu Vasive, Incorporated2021-03-01
Recon Support Catheter (K203275)C.R. Bard, Inc.2021-03-01
Analytic for Hemodynamic Instability (AHI) (DEN200022)Fifth Eye, Inc.2021-03-01
VALO Grand Corded and Accessory Lenses (K210550)Ultradent Products, Inc.2021-03-01
Nitrile Examination Gloves (Blue, Violet Blue, White) (K202402)Jiangsu Tianshuo Medical Products Co., Ltd.2021-03-01
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes (K201533)Avinent Implant System S.L.U.2021-03-01
Getinge GSS610N Series Steam Sterilizer (K201927)Maquet GmbH2021-03-01
QardioCore (K201644)Qardio, Inc.2021-02-28
Q-Collar (DEN200017)Q30 Sports Science, LLC2021-02-26
LTJ Screws and Washer (K210268)Azurmeds, Inc.2021-02-26
Laser Treatment System, Model: NYX and Grace (K210033)Canadian Pioneer Medical Technology Corporation2021-02-26
Ultrafast, Ultrafast Plus, Ultrafast Lite (K201387)Dentlight, Inc.2021-02-26
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System (K201968)CHISON Medical Technologies Co., Ltd.2021-02-26
Medical infrared forehead thermometer (K202111)Hunan Honggao Electronic Technolofy Co., Ltd.2021-02-26
AsoAligner (K201104)Aso International Manila, Inc.2021-02-26
Solax Electric Scooter (Model: S202261B) (K202549)Dongguan Prestige Sporting Goods Co., Ltd.2021-02-26
Indigo Aspiration System - Lightning Aspiration Tubing (K210323)Penumbra, Inc.2021-02-26
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System (K203819)Stryker GmbH2021-02-26
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Every clearance here is in the API, with alerts when new ones post.