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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

Resolv Endoscopic Hemostat System

Hemostasis, LLC

WellCare Anoscope

Well Care (Wuhan) Medical Technology Co., Ltd.

PRO Pen Microneedling System (6883)

Dermalogica, LLC

TSK SELECT™ Needle

Tsk Laboratory, Japan

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

Dcstar, Inc.

Tenex 2nd Generation System

Trice Medical, Inc.

Hearing assist

Meta Platform Technologies, LLC

myAir

Resmed Corp

Spencer Probe Depth Electrodes

Ad-Tech Medical Instrument Corporation

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

Fresenius Medical Care Renal Therapies Group, LLC

Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)

Shenzhen Nuon Medical Equipment Co., Ltd.

Electric Scooter

Anhui Jbh Medical Apparatus Co., Ltd.

Vital™ Spinal Fixation System

Zimvie Spine (Zimmer Biomet Spine, Inc.)

PRIMA Humeral System; PRIMA TT Glenoid

Lima Corporate S.P.A.

SOMNUM (V.1.1.2.)

Honeynaps Co., Ltd.

Da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

PYXIS 3D Titanium Cervical Cage system

GS Medical Co., Ltd.

SPY Cystoscope/Hysteroscope

Stryker Endoscopy

WatchPAT ONE (WP1)

Itamar Medical , Ltd.

Argo Knotless GENESYS Anchor

Conmed Corporation

REUNION Sacroiliac Joint Fusion System

Astura Medical

Erbe ESU Model VIO® 3n with Accessories

Erbe Elektromedizin GmbH

SMART Osteotomy System

Actis Medical Pty., Ltd.

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

Vivachek Biotech (Hangzhou) Co., Ltd.

Sterile Syringes for Single Use

Shanghai Kindly Enterprise Development Group Co., Ltd.

Reprocessed Agilis NxT Steerable Introducer

Innovative Health, LLC

AutoContour (Model RADAC V4)

Radformation, Inc.

InjecSURE Injection System

Carbon Medical Technologies, Inc.

Surgical Face Mask

Xiantao Deming Healthcare Products Co., Ltd.

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

Hangzhou Laihe Biotech Co., Ltd.

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