21 results · 43ms · Sources: EU EUDAMED, US FDA

UTAK Toxicology Control

FDA registration
UTAK LABORATORIES, INC.·1 product·🇺🇸 United States

TOXICOLOGY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

Drug Specific Control Materials

FDA classification
FDA Class 1 ·Drug Specific Control Materials

#810101-3; #810201-6; #810750; #810500-1; #810510-1; #810520-1;

FDA registration
VTS ONE MEMBER CO., Ltd.·1 product·🇻🇳 Vietnam

#810101-3; #810201-6; #810750; #810500-1; #810510-1; #810520-1;

FDA registration
MAMMON INTERNATIONAL CORP.·1 product·🇹🇼 Taiwan

#810101-3; #810201-6; #810750; #810500-1; #810510-1; #810520-1;

FDA registration
MAMMON INTERNATIONAL CORP.·1 product·🇨🇳 China

Helix

FDA UDI
Nuvasive, Inc.·00887517147868·Helix Self-Center Tack Tray, Base

TSRH® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978947907·CROSSLINK 810-201 LP CRSLK 5.0MM .675 SS

EXPLOR RADIAL HEAD PLATING SYSTEM

FDA registration
RMS CO.·2 products·🇺🇸 United States

EXPLORER RADIAL HEAD PLATING SYSTEM

FDA registration
BIOMET, INC.·2 products·🇺🇸 United States

Viant Medical, LLC

FDA registration
Viant Medical, LLC·1 product·🇺🇸 United States

BrainsWay Deep TMS System for Treatment of Decreasing Anxiety Symptoms in MDD (Model 102 & 104)

FDA registration
BRAINSWAY LTD.·1 product·🇮🇱 Israel

VistaTablet™ 2.0 RELAY (W/O VCI Box)

FDA UDI
Vital Connect, Inc.·00850490007368·VistaTablet is a tablet which will be running t...

VistaTablet™ 2.0 (Boxed)

FDA UDI
Vital Connect, Inc.·00850490007306·VistaTablet™ 2.0 (Boxed)

Optipore Sponge

FDA registration
Sterigenics US LLC·1 product·🇺🇸 United States

iNSitu™ Hip System

FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020322·Neck Trial, Size 1, Lateral

BAYER ADVIA IMS SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EXPLOR RADIAL HEAD PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Stryker Interventional Spine iVAS™ Inflator

FDA UDI
ATRION MEDICAL PRODUCTS, INC.·00856877002247·Inflation Device: 14mL, 30atm

Immunoassay Method, Troponin Subunit

FDA classification
FDA Class 2 ·Immunoassay Method, Troponin Subunit