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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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