510(k) Device Clearances

Zenith Micro Guidewire

Suzhou Zenith Vascular SciTech Limited

Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R an

Shenzhen AOJ Medical Technology Co., Ltd.

Elecsys Anti-HAV IgM

Roche Diagnostics

restor3d TIDAL Lumbar Interbody Fusion System

Restor3D

Caption Interpretation Automated Ejection Fraction Software

Caption Health

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

Olympus Medical Systems Corporation

DermaSensor

Dermasensor, Inc.

Vivo 3

Breas Medical AB

PHMB Wound Dressing

Winner Medical Co., Ltd.

OtoNova/OtoNova Pro

Otodynamics

Spinery™ RF Ablation System

Axon Spine Medical System

Stelo Glucose Biosensor System

Dexcom, Inc.

NewTom 7G

Cefla S.C.

Standard Tapered Bougie, 38 Fr.

Standard Bariatrics, Inc.

Tendon Protect (50242)

Kerecis Limited

OncoStudio

Oncosoft. Inc.,

DormoTech NLab

Dormotech Medical, Ltd.

Conductive carbon film electrode

Guangzhou Xinbo Electronic Co., Ltd.

SafetiCET Safety Lancet

Nsp Tech Pte, Ltd.

RoughRider Aurora Manual Wheelchair

Roughrider America, LLC

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

Meridian AG

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)

Guangdong Youmeng Electrical Technology Co., Ltd.

XCELLARISPRO TWIST microneedling device

Dermaroller GmbH

PICOHI

Hironic Co., Ltd.

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-

Shenzhen Nuon Medical Equipment Co., Ltd.

iCEM Universal Plus

Kulzer, LLC

HnX-P1, HnX-PB

H&abyz Co., Ltd.

IPL Hair Removal Device (SYL001AZ, SYL002AZ)

Gu'An Yeolight Smart Electronics Co., Ltd.

Ballancer Platinum (1222)

Mego Afek

Pangea Utility Plating System, Pangea Platform

Stryker GmbH