Atlas FDA

2021

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

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RecordFirmDate
H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two (K210972)CC Wellness, LLC2021-06-10
Symmetric Total Knee System (K203779)Signal Medical Corporation2021-06-10
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 (K211490)Stryker Corporation2021-06-09
Palm Bladder Scanner - PBSV7.1 (K210591)Mianyang Meike Electronic Equipment Co., Ltd.2021-06-09
Vivid S60N / Vivid S70N (K211216)GE Medical Systems Ultrasound and Primary Care Diagnostics2021-06-09
ELEOS Limb Salvage System with BioGrip (K203815)Onkos Surgical2021-06-09
Navigated Anterolateral Disc Prep Instruments (K211441)Medtronic Sofamor Danek USA, Inc.2021-06-09
Medical Face Mask (K211062)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.2021-06-08
Disposable Surgical Mask (K202126)Shenzhen Peninsula Medical Co., Ltd.2021-06-08
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (K210458)ABBOTT MEDICAL2021-06-08
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing (K211476)Imperative Care, Inc.2021-06-08
Suture Wing (K202663)Osteonic Co., Ltd.2021-06-07
X-Pac Expandable Lumbar Cage System (K203802)Expanding Innovations, Inc.2021-06-07
Augmented VaultLock Glenoid (K210050)Arthrex, Inc.2021-06-07
SnugKap (K193383)Headstart, Ltd.2021-06-07
Disposable Surgical Mask (K210372)Dongguan Shin YI Healthcare Products Factory2021-06-07
HRVWatch-Mini Wrist Monitor (K201914)Taiwan Scientific Corporation2021-06-07
Disposable Medical Mask (K210641)Tuosheng Protective Products (Ningbo) Co., Ltd.2021-06-07
Surgical Face Mask (Ear loops and Tie-on) (K210433)Wuhan Dymex Healthcare Co., Ltd.2021-06-07
Disposable Surgical Mask (K202580)Qingdao Likangyuan Medical Device Co., Ltd.2021-06-07
AlphaVac Multipurpose Mechanical Aspiration (MMA) System (K211081)AngioDynamics, Inc.2021-06-04
Perfect EMS (K200694)Tenscare, Ltd.2021-06-04
Insulia Diabetes Management Companion (K202596)Voluntis Sa.2021-06-04
Prudent 1717, Prudent 1417, Prudent 1212 (K211108)Pixxgen Corporation2021-06-04
SureStrip Vitrification Straw, SureLock Vitrification Straw (K203626)Allwin Medical Devices, Inc.2021-06-04
Avon Patello-femoral Joint Prosthesis (K211303)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2021-06-04
Micro C Medical Imaging System, M01 (K211473)Oxos Medical, Inc.2021-06-04
Surgical Green Laser System (K202828)Realton (Suzhou) Medical Technology Co., Ltd.2021-06-04
Surgical face mask (K203704)Juntech(Jiaxing)Healthcare Materials Co,.Ltd2021-06-04
Nitrile Patient Examination Gloves (K211028)Huayuan Medical Technology(Shangqiu) Co., Ltd.2021-06-04
Fix2Lock (PEEK Self Punching) (K202763)Osteonic Co., Ltd.2021-06-04
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) (K210014)Guandong Genial Technology Co., Limited2021-06-04
Disposable medical mask (K203388)Everwin Toys (Dongguan)., Ltd.2021-06-04
GlidePath 13F Long-Term Hemodialysis Catheter (K211410)Bard Peripheral Vascular, Inc.2021-06-04
HIT Clear Aligner (K210613)Cdb Corporation2021-06-04
Kendall NPWT Incision Management Device (K202217)Cardinalhealth2021-06-04
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (K201309)Mecta Corporation2021-06-04
TruBase S (K201842)Truabutment, Inc.2021-06-04
Dentis s-Clean s-Line Mini (K210080)Dentis Co., Ltd.2021-06-04
PCA-C1 series Patient Cable (K200722)QT Medical, Inc.2021-06-03
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K211401)Gyrus Acmi, Inc.2021-06-03
ASTRA Spine System (K211323)Spinecraft, LLC2021-06-03
Intellihab System (K210604)Cymedica Orthopedics, Inc.2021-06-03
Breezeway II (K210627)Oscor, Inc.2021-06-03
Allmed Surgical Face Masks (Ear loops) (K202128)Allmed Medical Products Co., Ltd.2021-06-03
6MS Invisible Aligner (K210652)Sms Opco, LLC2021-06-02
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System (K200891)Becton, Dickinson and Company2021-06-02
Surgical Face Mask (K203190)Rfx+Care Manufactoring Co., Ltd.2021-06-02
SeaSpine WaveForm™ A Interbody System (K210583)SeaSpine Orthopedics Corporation2021-06-02
NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229)Allergan2021-06-02
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) (K211372)Mahana Therapeutics, Inc.2021-06-02
Disposable Medical mask (K210150)Hubei Wanli Protective Products Co., Ltd.2021-06-02
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) (K211051)DePuy Synthes2021-06-02
Disposable Surgical Face Mask (K210429)Jiangxi Heying Pharmaceutical Co., Ltd.2021-06-02
Transpara 1.7.0 (K210404)Screenpoint Medical B.V.2021-06-02
Cognoa ASD Diagnosis Aid (DEN200069)Cognoa, Inc.2021-06-02
ASM-301 Level 3 Surgical Mask (K211440)American Surgical Mask Company, LLC2021-06-02
Arthrex Beveled FT Screws (K210994)Arthrex, Inc.2021-06-01
Well-Life Garment Electrodes (GM Series) (K200942)Well-Life Healthcare Limited2021-06-01
Single Use Injection Needle (K210917)Anrei Medical (Hangzhou) Co., Ltd.2021-05-28
AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)AtriCure, Inc.2021-05-28
LINQ II Insertable Cardiac Monitor (K211304)Medtronic, Inc.2021-05-28
ABT12 multi-purpose solution (K202932)Bausch & Lomb, Incorporated2021-05-28
coraCross (K210188)Reflow Medical2021-05-28
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems (K211344)Medos International SARL2021-05-28
Irrisept Antimicrobial Wound Lavage (K210536)Irrimax Corporation2021-05-28
Infant Phototherapy Equipment (K210289)Bistos Co., Ltd.2021-05-28
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687)Edwards Lifesciences, LLC2021-05-28
INVU by Nuvo (K210025)Nuvo- Group , Ltd.2021-05-28
Axis Charcot Fixation System (K211261)Extremity Medical, LLC2021-05-28
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters (K200607)Waldemar Link GmbH & Co. KG2021-05-28
Pathfinder Endoscope Overtube (K211301)Neptune Medical, Inc.2021-05-28
LigaPASS® Spinal System, CD Horizon™ Spinal System (K211057)Medtronic, Inc.2021-05-27
ZedView (K200704)Lexi Co., Ltd.2021-05-27
SafeBreak Vascular (DEN190043)Site Saver, Inc. D/B/A Lineus Medical2021-05-27
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765)Careplus (M) Sdn Bhd2021-05-27
BIB Stent Placement Catheter (K211134)NuMED, Inc.2021-05-27
Aqua Medical RF Vapor System (K211282)Aqua Medical, Inc.2021-05-27
GalaSTITCH Absorbable Monofilament Suture (K211307)Tepha, Inc.2021-05-27
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads (K201639)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2021-05-27
Breast Volume Navigator (BVN) Model G-2000 (K211098)Metritrack, Inc.2021-05-26
Disposable Synthetic Examination Gloves (K210520)Shandong Shengshixincheng Medical Science & Technology Co.,2021-05-26
Implacil Implant System (K202832)Implacil DE Bortoli Material Odontologico Ltda2021-05-26
Fassier-Duval Telescopic IM System (K211292)Pega Medical, Inc.2021-05-26
PlasmaWave (K211253)Manamed, Inc.2021-05-26
SpyGlass Discover Retrieval Basket (K203322)Boston Scientific Corporation2021-05-26
Peak flow meter (K203196)Shanghai Sonmol Medical Equipment Co., Ltd.2021-05-26
ViperCath XC Peripheral Exchange Catheter (K211251)Cardiovascular Systems, Inc.2021-05-26
OTE MPS 045 Multi-purpose Lens Care Solution (K210051)Ote North America, LLC2021-05-26
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (K211258)Medtronic Sofamor Danek USA, Inc.2021-05-26
HeRO Graft, HeRO Adapter (K203724)Merit Medical Systems, Inc.2021-05-25
MicroPen EVO (K203144)Eclipse Medcorp, LLC2021-05-25
LUX-Dx Insertable Cardiac Monitor (K210608)Boston Scientific Corporation2021-05-25
AirMax Procedure Mask (K211275)Premiumestore, LLC2021-05-25
Air Relax Plus Model AR-3.0 (K211460)Diode Art Engineering Doing Business AS Air Relax2021-05-25
E-Dent 1000 (K210977)Envisiontec GmbH2021-05-25
MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (K211313)Synthes (USA) Products, LLC2021-05-25
Pathfinder Endoscope Cap (K210915)Neptune Medical, Inc.2021-05-25
Tokuyama Universal Bond II (K203760)Tokuyama Dental Corporation2021-05-25
Catalyft PL Expandable Interbody System (K210425)Medtronic Sofamor Danek USA, Inc.2021-05-24
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Every clearance here is in the API, with alerts when new ones post.