10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
LIA Console (542-7)
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106150·HOSKIN #30 COLIBRI FORCEPS
MATRIX HOLTER SYSTEM, MODEL M12
FDA 510(k)
FDA Class 2
·Cardiovascular
Magellan Robotic System
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 5, 2014
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FRN·August 31, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013
ARCOS HA MODULAR REVISION SYSTEM CONE PROX BODY SIZE A HIGH OFFSET 70MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 12, 2016
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·March 21, 2018
ARCOS HA MODULAR REVISION SYSTEM CONE PROX BODY / TY I TAPER SZ A HIGH OFFSET 70
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 11, 2016