510(k) Device Clearances

NIRA Model 2

Dermal Photonics Corp

OxiplexTS200

Iss Medical, Inc.

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

Wuhan Guangdun Technology Co.,Ltd..

FMT Reusable Temperature Probes

Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti

BoneMRI v1.6

Mriguidance B.V.

Electro Lube NXT

Steris

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endosco

Anx Robotica Corp

CoLumboX

Smart Soft Healthcare AD

Earflo (EF001)

Earflo, Inc.

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

ABBOTT MEDICAL

Negative Pressure Wound Therapy Device (V-Move, V-Grand)

Med Way, Inc.

Lap.Ox™ Laparoscopic Tissue Oximeter

ViOptix, Inc.

IPL Cooling Hair Removal Device

Shenzhen Siken 3D Technology Development Co., Ltd.

Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, L

Bonebridge AG

Digistat Care

Ascom Ums Srl Unipersonale

Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

Shenzhen Medke Technology Co., Ltd.

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

BIOFIRE Respiratory Panel 2.1 (RP2.1)

Biofire Diagnostics

Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

Shenzhen Imdk Medical Technology Co., Ltd.

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

Safesource Direct, LLC

Ion 3D

SurGenTec, LLC

C-Lant Port

Vigor Medical Technologies , Ltd.

X-ray Flat Panel Detectors (EverestView 4343X)

Careray Digital Medical Technology Co., Ltd.

Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System

Tyber Medical, LLC

Suture-TOOL System

Suturion AB

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes

Zmi Electronics , Ltd.

Electric Wheelchair

Shanghai Bangbang Robotics Co., Ltd.

AviClear Laser System

Cutera, Inc.

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD

DRTECH Corporation

Rapid Aneurysm Triage and Notification

Ischemaview, Inc.