510(k) Device Clearances

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

Wishbone Medical, Inc.

ProBeam 360° Proton Therapy System

Varian Medical Systems, Inc.

Xpert Xpress CoV-2/Flu/RSV plus

Cepheid®

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Coch

Cochlear

iFuse INTRA Ti™ Implant System

SI-BONE, Inc.

da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

Intuitive Surgical, Inc.

Cross Wise™ Multi-Use RF Adapter Cable

Circa Scientific, Inc.

Pisces™-SA STANDALONE ALIF Interbody System

Osseus Fusion Systems

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Ulrich GmbH & Co. KG

Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA

American Medical Endoscopy, Inc.

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wi

Merit Medical Ireland, Ltd.

Micro Catheter

Suzhou Zenith Vascular SciTech Limited

Galen™ Second Read™

Ibex Medical Analytics , Ltd.

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

Quality IN Flow , Ltd.

Neurophet AQUA (V3.1)

Neurophet., Inc.

Tinnitogram Signal Generator

Goldenear Company, Inc.

Digital Thermometer, Model T28, T28L

Guangdong Genial Technology Co., Ltd.

INLIANT Surgical Navigation System

Navigate Surgical Technologies, Inc.

P20 Elite Series Digital Color Doppler Ultrasound System

Sonoscape Medical Corp.

Invictus Robotic Navigation Instruments

Alphatec Spine

Non Absorbable Surgical Nylon Suture

Shandong Haidike Medical Product Co., Ltd.

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

Ever Fortune.Ai, Co., Ltd.

Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3

Sleepnet Corporation

Hot and Cold Compression System (A02-C-032)

Chengdu Cryo-Push Medical Technology Co.,Ltd

Disposable Distal Cap

Mirco-Tech (Nanjing) Co., Ltd.

LUNE™ PureHygiene

Enamel Pure

Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System

Imperative Care, Inc.

Leltek Ultrasound Imaging System (Model: LU700 Series)

Leltek, Inc.

Ball Joint Guide Array (66295)

Bayer Medical Care, Inc.

Powder-Free Latex examination gloves

Guangdong Kingfa Sci. & Tech.Co., Ltd.