7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EBI PERIARTICULAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Aviator Anterior Cervical Plate (ACP) System
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 1, 2014
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 22, 2012
SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 12, 2015
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