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
BTL-785NEH
BTL Industries, Inc.
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Bios S.R.L.
NeuroSwift Pro
Neurobit Technologies Co., Ltd.
LYMA Laser
Lyma Life , Ltd.
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Power
Lexington Medical, Inc.
Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
Jiangmen Ningrui Medical Supplies Co., Ltd.
Elecsys HSV-1 IgG (08948844160)
Roche Diagnostics
mBôs (Monogram mBôs TKA System)
Monogram Orthopaedics, Inc.
Apex Flex
Sprintray, Inc.
Kangbeier Child Surgical Mask
Xinxiang Kangbeier Medical Technology Co., Ltd.
OneTouch Delica Plus Lancing System
Asahi Polyslider Co., Ltd.
15L Cycler Drainage Bag
Baxter Healthcare Corporation
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Dexcom, Inc.
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Wontech Co., Ltd.
SIMDA Abutments
Simda Co., Ltd.
Al-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
OpenRad Cloud
Openrad Services Uk, Ltd.
Anthem Fracture System
Globus Medical, Inc.
Salix Coronary Plaque (V1.0.0)
Artrya Limited
Identity Revision Humeral Stems
Zimmer, Inc.
NeuroSENSE Monitoring System, Model NS-901
Neurowave Systems, Inc.
Z1 Hip System
Zimmer, Inc.
Amethyst HP PTA OTW 0.035 Catheter
Natec Medical , Ltd.
JDZygoma dental implants
Jdentalcare Srl
Infant Heel WarmerTM; Heel Snuggler®
International Biomedical
MSS - Humeral reverse liners extension
Medacta International, SA
BB 8 Sinus Dilation Kit
Excelent, Inc.
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
Outset Medical, Inc.
Verisafe Safety Sterile Needles (SSN)
Promisemed Hangzhou Meditech Co., Ltd.
EVOL® ha Hyper C Cervical Interbody Fusion System
Cutting Edge Spine, LLC
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