510(k) Device Clearances

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S

Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.

Onetouch Non-paraben Lubricant Gel

Thai Nippon Rubber Industry Public Company Limited.

Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit

Siemens Medical Solutions USA, Inc.

BlueCheck™ Caries Detection & Monitoring

Incisive Technologies Pty, Ltd.

3D Printed PEEK Interbody System

Nvision Biomedical Technologies, Inc.

3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader

3M Company

DoubleChek DC-1001

Nasogastric Feeding Solutions, Ltd.

Estremo Fibular Nail

Citieffe S.R.L.

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

Olympus Medical Systems Corporation

Avitus® DragonWing Large Volume Autograft Delivery System

Avitus Orthopaedics, Inc.

FlowArt® Needle-Free Split Septum Valve

Asset Medikal Tasarim San Tic As.

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter,

Centerline Biomedical, Inc.

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

Biofire Diagnostics, LLC

GEM ZIPCLIP

Synovis Micro Companies Alliance A Subsidiary of Baxter Int

LUXEN 5G

Dentalmax Co., Ltd.

Ultravision2™ IonPencil

Alesi Surgical Limited

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

Hl Rubber Industries Sdn Bhd

Respiratory Gating for Scanners v2.0

Varian Medical Systems, Inc.

Tyber Medical Trauma Screw

Tyber Medical, LLC

BONX805

Bontech Co., Ltd.

aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion

Carlsmed, Inc.

GenaCheck COVID-19 Rapid Self-Test

Genabio Diagnostics, Inc.

LIXI (LXOSFM1)

Luwi, LLC

Luja Coudé

Coloplast Corp.

SEJONG Surgical Gown Soft

Sejong Healthcare Co., Ltd.

NaviCam Xpress Stomach System, NaviCam Xpress System

Anx Robotica Corp

M.U.S.T. MINI Posterior Cervical Screws System Extension

Medacta International S.A.

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

FUJIFILM Healthcare Americas Corporation

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

See-Mode Technologies Pte, Ltd.