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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