8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ACUFEX INTRA ARTICULAR MEASURING DEVICE
FDA 510(k)
FDA Class 1
·Orthopedic
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111079·SILICONE MAT FOR K 9-2330
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SILICOATER SYSTEM
FDA 510(k)
FDA Class 2
·Dental
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·January 17, 2013
CONFIRM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code MXC·January 15, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 23, 2010
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021