10 results
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18ms
·
Sources: EU EUDAMED, US FDA
ANCHOR BIOPSY NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·J0228731241·GC Initial™ AL Cervical Transluc. CT-24, 20g
TOWNLEY™ Transfacetpedicular Screw Fixation System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490860536·UCS 4.0X24 X873-124 CANN LAG SCR TI
PEEK Biosolution
FDA 510(k)
FDA Class 2
·Dental
COLLIMARE COLLIMATOR FAMILY
FDA 510(k)
FDA Class 2
·Radiology
CASING FOR 12V BATTERY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 13, 2014
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·October 18, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 13, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014