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
Spectra Wearable
Uzinmedicare Co., Ltd.
Safety Heel Lancet
Ningbo Medsun Medical Co., Ltd.
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
Jiangxi Royall Smart Technology Co., Ltd.
MammoScreen BD
Therapixel
Blood Collection Needle (with/without Needle Holder)
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
SMB Luer lock disposable syringe
Smb Corporation of India
Anterior Spine Truss System-Stand Alone (ASTS-SA)
4Web Medical, Inc.
Genius AI Detection 2.0
Hologic, Inc.
Armory Motion
Pain Management Technologies, Inc.
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
STERIS Corporation
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
Geske Beauty Tech GmbH
Nd: YAG Laser Therapy Systems
Sanhe Meditech Co., Ltd.
Orthex External Fixation System
OrthoPediatrics Corp.
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
Rhino Health, Inc.
SonoMSK
PAJUNK GmbH Medizintechnologie
VITA Akzent LC
Vita Zahnfabrik GmbH H Rauter & CO
IO Needle Safety Sheath
Actuated Medical, Inc.
R&G Surgical Mask
R&G Seguridad E Higiene Industrial S.A.C.
Phototherapy System (DUV-COMBO)
Choyang Medics Co., Ltd.
Osteon Precision Milled Suprastructure
Implant Solutions Pty Ltd (Aka Osteon Medical)
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Philips Medical Systems Nederland B.V.
SOLACE Sacroiliac Fixation System
Ht Medical, LLC Dba Xenix Medical
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
Ram.Shaw Pte. , Ltd.
ROSA® Shoulder System
Orthosoft Inc. (d/b/a) Zimmer CAS
The Trust
Genoss Co., Ltd.
3Delta UNlimited
Deltamed GmbH
AUTION MAX AX-4060 Urinalysis System
Arkray, Inc.
Pixie Skin Tag
Oystershell NV
Root canal repair materials (nRoot BP)
Enpuno Biotechnology Co., Ltd.
ANT-X System
Ndr Medical Technology Pte. , Ltd.
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