510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Im
Wuxi Hisky Medical Technologies Co., Ltd.
LOTUS Series 4 Enhanced Shears, LOTUS Series 5
Sra Developments, Ltd.
Grass® MR Conditional/CT Cup Electrodes
Natus Manufacturing Limited
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U10
Unimed Medical Supplies, Inc.
Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
Masimo CARESCAPE SpO2 Masimo with SpHb
Masimo Corporation
Disposable Laryngeal Electrodes
Suzhou Haishen Medical Device Associates Co., Ltd.
NuVasive Cohere ALIF System Intervertebral Body Fusion Device
Nu Vasive, Incorporated
Icona Hip Stem
Corin U.S.A. Limited
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
Shanghai AnQing Medical Instrument Co., Ltd.
Sleep Apnea Feature
Samsung Electronics Co., Ltd.
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14
Poly Medicure Limited
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
Anhui Xinyisheng Medical Technology Co.,Ltd
EZ-FIDUCIALS
Phasor Health, LLC
Elemental Granulate
Zinkh NV
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation
HIGHERDOSE Body Sculptor (Model: GS-03)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
A.L.P.S. Proximal Humerus Plating System
Zimmer Biomet
Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
DD Hybridlayer (multicolored zirconia)
Dental Direkt GmbH
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
B.Braun Medical, Inc.
EdgePro
Biolase, Inc.
Kubec Xpert 80 Radiography System
Kub Technologies, Inc.
3M Filtek Supreme Flowable Restorative
3M Company Espe Dental Products
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Suzhou Endophix Co., Ltd.
Baylis Connector Cable
Baylis Medical Technologies, Inc.
UNiD Spine Analyzer (SW3002)
Medicrea International S.A.S. (Medtronic)
Infinity OCT System
Medtronic Sofamor Danek USA, Inc.
Hemoclip
Hangzhou AGS MedTech Co., Ltd.
Cool-tip RF Ablation System E Series
Covidien, LLC
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