Atlas FDA

2020

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

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RecordFirmDate
3M Comply Hydrogen Peroxide Indicator Tape 1228 (K203285)3M Company2020-12-10
Cystoject Syringe Lever (K203321)Urogen Pharma, Ltd.2020-12-09
ClearPetra Suction-Evacuation Sheath (K203119)Well Lead Medical Co., Ltd.2020-12-09
Infrared Body Thermometer (K200781)Heitaida Technology Co., Ltd.2020-12-09
V30 system, V20 system, V10 system, V-VR Hand piece (K202247)Viora , Ltd.2020-12-09
Disposable Surgical Mask (K201893)Xiamen Probtain Medical Techology Co., Ltd.2020-12-09
Mini Spike Plus 6/8R (K201469)B.Braun Medical, Inc.2020-12-09
Accu-Joint Hemi Implant (K200951)Accufix Surgical, Inc.2020-12-08
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (K201253)Smith & Nephew2020-12-08
CD Horizon Spinal System Instruments (K203291)Medtronic Sofamor Danek USA, Inc.2020-12-08
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K202661)Olympus Medical Systems Corp.2020-12-08
easy Hairfull (K202983)Y & J Bio Co., Ltd.2020-12-08
Novapak Nasal Sinus Packing and Stent (K202623)Medtronic Xomed2020-12-08
Biofeedback Nerve and Muscle Stimulator (K202648)Shenzhen Konmed Technology Co., Ltd.2020-12-08
Taperloc® Complete Hip Stems (K200196)Biomet Orthopedics2020-12-08
CARES Screw - Retained Bars and Bridges (SRBB) (K201711)Medentika GmbH2020-12-08
iHelmet Laser Comb (K202631)Slinph Technologies Co., Ltd.2020-12-08
Graffiti (K202189)Ge Medical Systems Information Technologies, Inc.2020-12-08
Biomonitor III, Biomonitor IIIm (K201865)Biotronik, Inc.2020-12-08
Ophthalmic Yag Laser System YC-200 (K203130)Nidek Co., Ltd.2020-12-07
YUWELL Infrared Thermometer (K201864)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2020-12-07
GIA Stapler with Tri-Staple Technology (K202701)Covidien2020-12-07
BNA Platform (K202588)Elminda, Ltd.2020-12-07
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens (K200618)Visco Vision, Inc.2020-12-07
Vortex Radial Spray Catheter (K201183)CSA Medical, Inc.2020-12-07
Impella XR Sheath Set (K202330)Abiomed, Inc.2020-12-07
Callaly Tampliner (K201003)Calla Lily Personal Care, Ltd.2020-12-07
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (K203284)3M Company2020-12-07
HepaFat-AI (K201039)Resonance Health Analysis Services Pty, Ltd.2020-12-07
B-Secur HeartKey Software Library (K200884)B-Secur , Ltd.2020-12-07
Pulse Oximeter (K201384)Shenzhen Raysintone Technology Co., Ltd.2020-12-07
Pulse Oximeter (K202173)Shenzhen AOJ Medical Technology Co., Ltd.2020-12-07
Transtek Wrist Blood Pressure Monitor (K202599)Guangdong Transtek Medical Electronics Co., Ltd.2020-12-06
DVT-2600 (K203016)Daesung Maref Co., Ltd.2020-12-05
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K200876)Dexcom, Inc.2020-12-04
Nucleus.io (K203249)Nucleushealth, LLC2020-12-04
GoSpiro (K202837)Monitored Therapeutics, Inc.2020-12-04
Vagisan MoistCream Cremolum (K193444)Dr. August Wolff GmbH & Co. KG Arzneimittel2020-12-04
TTBIO EVOCLEAN Ultrasonic Scaler (K201317)Ttbio Corp.2020-12-04
TubeClear System (K200646)Actuated Medical, Inc.2020-12-04
Neocis Guidance System (NGS) with Yomi Plan v2.0 (K202264)Neocis, Inc.2020-12-04
Electronic Blood Pressure Monitor (K200716)Shenzhen Pango Electronic Co., Ltd.2020-12-04
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System (K200789)L&K BIOMED Co., Ltd.2020-12-04
Dynamic Gas Scavenging System 2 (DGSS - 2) (K193646)Anesthetic Gas Reclamation, Inc.2020-12-04
HealthJOINT (K202487)Zebra Medical Vision, Ltd.2020-12-04
FlowTriever Retrieval/Aspiration System (K201541)Inari Medical2020-12-04
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 (K193508)Oxoid Limited (Part of Thermo Fisher Scientific)2020-12-04
InBody (K200442)Inbody Co., Ltd.2020-12-04
Braces on Demand Bracket (K201940)Braces on Demand, Inc.2020-12-03
ORISE ProKnife (K200404)Boston Scientific Corporation2020-12-03
NuVasive ACP System (K203253)Nu Vasive, Incorporated2020-12-03
TempTraq (K201977)Blue Spark Technologies, Inc.2020-12-03
Medical Mask (K201729)Zhende Medical Co., Ltd.2020-12-03
Tricoglam Home Use (K193008)Advihair S.R.L.2020-12-03
AireHealth NebulizerTM (K201167)Airehealth, Inc.2020-12-03
NobelProcera Zirconia Implant Bridge (K202452)Nobel Biocare AB2020-12-03
Magic UCLA Abutment System (K202418)Innobiosurg Co., Ltd.2020-12-03
CombiDiagnost R90 (K203087)Philips Medical Systems Dmc GmbH2020-12-03
LineSider™ Spinal System (K203367)Integrity Implants, Inc.2020-12-03
aprevo Intervertebral Body Fusion Device (K202034)Carlsmed, Inc.2020-12-03
Auryon Atherectomy System (K202835)Eximo Medical, Ltd.2020-12-02
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K203053)Canon Medical Systems Corporation2020-12-02
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (K201072)Ensemble Orthopedics, LLC2020-12-02
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (K202270)K1 Medical, LLC2020-12-02
NuVasive Navigation.S Instruments (K200719)Nu Vasive, Incorporated2020-12-02
Palm Care Blue Nitrile Examination Gloves Powder Free (K202384)Hi-Care Thai Gloves Co. , Ltd.2020-12-02
Lux 35 Detector (K203159)Carestream Health2020-12-02
WAVICIDE-OPA MEC Indicator (K202565)Serim Research Corporation2020-12-02
Planmeca Romexis (K200572)Planmeca Oy2020-12-02
SMS Cementless Stem (K203041)Medacta International S.A.2020-12-02
Confirm Rx Insertable Cardiac Monitor (K202876)Abbott (St. Jude Medical)2020-12-01
AcQMap High Resolution Imaging and Mapping System (K201015)Acutus Medical, Inc.2020-12-01
SLIMUS (K192970)Hironic Co., Ltd.2020-12-01
BASE4 Disposable Medical Mask (K202069)Base4 Group, Inc.2020-12-01
Z5-TL (K201712)Z-Systems AG2020-12-01
Stryker Arthroscope (K202659)Stryker2020-12-01
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (K203199)STERIS Corporation2020-12-01
Apolo D / Apolo S (K202388)Vmi Tecnologias Ltda2020-12-01
Palm Care Latex Examination Powder Free Gloves (K202377)Hi-Care Thai Gloves Co. , Ltd.2020-12-01
Avenda Health Treatment System (K201687)Avenda Health, Inc.2020-11-30
Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil (K200372)Modern Medical Equipment Manufacturing, Ltd.2020-11-30
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (K202416)Kimberly Clark Corporation2020-11-30
Bright High Flow (K200155)Genoss Co., Ltd.2020-11-30
Spo2 Sensor (K202851)Jkh USA, LLC2020-11-27
Arthrex FiberTak Suture Anchor (K203268)Arthrex, Inc.2020-11-27
Axonpen, Axonmonitor, Axonbox, Tablet (K201308)Clearmind Biomedical2020-11-27
E-Guard (K201173)Envisiontec GmbH2020-11-27
Pulse Oximeter (K201294)Guangdong Long Yao Electronic Technology Co., Ltd.2020-11-27
Compex Sport Elite 3.0 (K201653)Djo, LLC2020-11-27
GLOBAL UNITE™ Platform Shoulder System (K202098)Depuy Ireland UC2020-11-25
TopLock Anchor System (K193377)Fusion Orthopedics, LLC2020-11-25
Sterile bone screw (PEEK ACL screw) (K202883)Osteonic Co., Ltd.2020-11-25
Parallel (DEN200029)Mahana Therapeutics, Inc.2020-11-25
Physiq (K202079)El.En Electronic Engineering Spa2020-11-25
SysMed S/T (K192177)Sysmed (China) Co., Ltd.2020-11-25
AveCure BT Microwave Ablation System (K192406)Medwaves, Inc.2020-11-25
CarboClear X Pedicle Screw System (K203317)CarboFix Orthopedics , Ltd.2020-11-25
CPR Face Shield (K192285)Firstar Healthcare Company Limited (Guangzhou)2020-11-25
PRE-MILLED Abutment (K202269)Mit Global Co., Ltd.2020-11-25
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (K202066)ABBOTT MEDICAL2020-11-25
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Every clearance here is in the API, with alerts when new ones post.