Atlas FDA

2021

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

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RecordFirmDate
CoreLink Midline Fixation System (K210539)Corelink, LLC2021-04-15
GD Disposable Medical Face Mask (K201718)Jiangsu Guangda Medical Material Group Co., Ltd.2021-04-15
Artimes pro Balloon Dilatation Catheter (K203390)Brosmed Medical Co., Ltd.2021-04-14
CX30N (CX30PQX) (K210493)Wide Corporation2021-04-14
F&P Visairo NIV Mask Range (K203449)Fisher & Paykel Healthcare, Ltd.2021-04-14
BriefCase, RIB Fractures Triage (RibFx) (K202992)Aidoc Medical , Ltd.2021-04-14
DEFEND Ear-loop Face Masks (K201127)Young Dental Manufacturing Co. 1, LLC2021-04-14
AMSure® Single Use Saline Topical Solution (K201138)Amsino Medical, Inc.2021-04-14
Metapex Plus (K202617)Meta Biomed Co., Ltd.2021-04-14
HydroMARK Breast Biopsy Site Marker (K210752)Devicor Medical Products, Inc.2021-04-14
Cannulated Fasteners and Nuts (K210754)OsteoCentric Technologies2021-04-14
SR-1 Skin Treatment System (K202884)AVAVA, Inc.2021-04-13
EndoPilot2 (K202906)Schlumbohm GmbH & Co. KG2021-04-13
Flyte (K210764)Pelvital USA, Inc.2021-04-13
IDS Cortisol (K202136)Immunodiagnostic Systems , Ltd.2021-04-13
NFC-600 Automated Portable Retinal Camera (K210197)Crystalvue Medical Corporation2021-04-13
Volition Plating System (K210658)Ortho Solutions UK , Ltd.2021-04-13
RetCam Envision (K203500)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2021-04-13
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes (K210088)Stryker2021-04-13
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere (K210436)Alcon Laboratories, Inc.2021-04-12
Athena Surgical RMUS System (K210087)Athena Surgical, LLC2021-04-12
Invacare Platinum 5NXG Oxygen Concentrator (K203210)Invacare Corporation2021-04-12
OMNIVision system (K203751)Corin USA2021-04-12
Ligament Staple (K210456)Medacta International S.A.2021-04-12
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900)Canon Medical Systems Corporation2021-04-12
Idys ALIF 3DTi (K200919)Clariance2021-04-12
SecurAcath (K210629)Interrad Medical, Inc.2021-04-12
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (K202679)Mcgovern Medical School2021-04-12
Velocity Alpha Highspeed Surgical Drill System (K191479)Adeor Medical AG2021-04-11
Medical Surgical Mask (Non-sterile) (K202761)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.2021-04-11
Surgical Mask (K203012)Customfab, Inc.2021-04-11
Disposable Medical Mask (K210018)Diasia Biomedical Technology Co., Ltd.2021-04-11
KeyPrint KeySplint Hard (K203000)Mycone Dental Supply Co. Inc. (Dba Keystone Industries)2021-04-09
PENTAX Medical Video Duedenoscope ED34-i10T2 (K210710)Pentax of America, Inc.2021-04-09
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System (K210068)Samsung Medison Co., Ltd.2021-04-09
EasyPoint Blood Collection Plus (K202325)Retractable Technologies, Inc.2021-04-09
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K203571)Acuity Polymers, Inc.2021-04-09
Endoscope Model EI-740D/S (K210162)Fujifilm Corporation2021-04-09
HYPER Focus (K210418)Shanghai United Imaging Healthcare Co., Ltd.2021-04-09
hekaDrill (K193630)Zethon, Ltd.2021-04-09
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review (K203681)Brainlab AG2021-04-09
PuRE PMMA Disc (K201563)Quest Dental USA Corp.2021-04-09
Electric breast pump (Models: RH-228 and RH-338) (K201903)Cixi Ruihong Electric Appliance Co., Ltd.2021-04-09
GI Genius (DEN200055)Cosmo Artificial Intelligence - Ai, Ltd.2021-04-09
Disposable Medical Face Mask-Model FM-04 (K202513)Shenzhen Jinko Industrial Co., Ltd.2021-04-09
Enteral Feeding Catheter (K202748)Medcaptain Life Science Co., Ltd.2021-04-09
DeepLook PRECISE (K202084)Deeplook, Inc.2021-04-09
IdentiTi ALIF Standalone Interbody System (K203742)Alphatec Spine, Inc.2021-04-09
Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K202729)Microlife Intellectual Property GmbH2021-04-08
CW120N (K210491)Wide Corporation2021-04-08
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System (K202785)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2021-04-08
DePuy Synthes Variable Angle Locking Patella Plating System (K210408)Synthes (USA) Products, LLC2021-04-08
Electric wheelchair (S7204/S7205) (K202632)Dongguan Prestige Sporting Goods Co., Ltd.2021-04-08
Well Lead All Silicone Foley Catheter with Temperature Sensor (K202134)Well Lead Medical Co., Ltd.2021-04-08
Mectaplug PE II (K210062)Medacta International S.A.2021-04-08
ActivSight Intraoperative Imaging System (K203550)Activ Surgical, Inc.2021-04-08
Blustone Synergy Interbody Fusion System (K203520)Blustone Synergy, LLC2021-04-07
Huber Needle Infusion Set, Safety Huber Needle Infusion Set (K200463)Jiangsu Caina Medical Co.,Ltd2021-04-07
PANAMA™ Anterior Cervical Plate (ACP) System (K210182)Flospine2021-04-07
Nitrile Examination Gloves (K210106)Zhenjiang Huayang Latex Products Co., Ltd.2021-04-07
PicoLO Nd: YAG Picosecond Laser System (K203491)Laseroptek Co., Ltd.2021-04-07
CATALYS Precision Laser System (K210701)Amo Manufacturing USA, LLC2021-04-07
Disposable Surgical Face Mask (K203801)Anhui Jiabao Protective Equipments Co., Ltd.2021-04-06
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (K203673)Medacta International S.A.2021-04-06
Endovascular Dilator and Sets (K210734)Cook Incorporated2021-04-06
Physica system (K210554)Lima Corporate S.P.A.2021-04-06
Vascutek Gelsoft Plus ERS Vascular Graft (K202703)Vascutek, Ltd.2021-04-06
SiteSeal SV (K210681)Ensite Vascular2021-04-06
Auxein Brand Vertaux 5.5 mm Pedicle Screw System (K201457)Auxein Medical Private Limited/711642021-04-06
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) (K201257)Arrive Systems, Inc.2021-04-06
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments (K210716)CarboFix Orthopedics , Ltd.2021-04-06
AcQCross Qx Integrated Transseptal Dilator/Needle (K210685)Acutus Medical, Inc.2021-04-06
StentBoost Mobile (K203623)Philips India Limited2021-04-05
Oral-B Dry Mouth Oral Rinse (K203567)The Procter & Gamble Company2021-04-05
Disposable Medical Mask (K202655)Dongguan Runlin Medical Supplies Technology Co., Ltd.2021-04-05
Stockert S5 System (K210130)Livanova Deutschland, GmbH2021-04-05
DOUBLEFLO system (K203480)Hemodia Sas2021-04-05
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank (K203499)Vatech Acucera, Inc.2021-04-05
ADAS 3D (K210850)Adas3D Medical S.L.2021-04-05
Medline Orbis Surgical Gown (K202447)Medline Industries, Inc.2021-04-02
SkinPen Precision System (K202243)Crown Aesthetics2021-04-02
Surgical Face Mask (K210023)Guangdong Winsun Personal Care Products Co.,Ltd2021-04-02
CreoDent Solidex Customized Abutment (K202909)Creodent Prosthetics, Ltd.2021-04-02
Polaris Spinal System (K210275)Zimmer Biomet Spine, Inc.2021-04-02
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable (K201171)Leoni Fiber Optics, Inc.2021-04-02
Pristine Long-Term Hemodialysis Catheter (K203767)C B Bard, Inc.2021-04-02
DeGen Navigated Instrumentation (K203816)Degen Medical2021-04-02
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System (K203310)Jiangsu Synecoun Medical Technology Co., Ltd.2021-04-02
Extended HA Half Pins (K210784)Smith & Nephew, Inc.2021-04-02
Global Shoulder and Delta CTA systems (K203230)Depuy Lnc.2021-04-02
Eclipse II with Smart Noise Cancellation (K202441)Carestream Health, Inc.2021-04-02
DigitalDiagnost (K210692)Philips Medical Systems Dmc GmbH2021-04-02
DV. Target (K202928)Deepvoxel, Inc.2021-04-02
ClearPath Disposable Introducer (K210251)Clearmind Biomedical2021-04-02
Apex Knee System (K201611)Omnilife Science2021-04-02
Porcine Mineral Collagen Composite (K202183)Collagen Matrix, Inc.2021-04-02
KMTI Hip Replacement System (K203472)Kyocera Medical Technologies, Inc.2021-04-02
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System (K210300)Vuesonic, LLC2021-04-01
ACUSON Redwood Diagnostic Ultrasound System (K210743)Siemens Medical Solutions USA, Inc.2021-04-01
Star RF Electrode, VIVA RF Electrode (K203795)Starmed Co., Ltd.2021-04-01
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Every clearance here is in the API, with alerts when new ones post.