8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TRIGEMINAL SCISSORS
FDA 510(k)
FDA Class 1
·Orthopedic
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
FDA 510(k)
FDA Class 2
·Anesthesiology
BOSS Toe Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
K-WIRE, RECON 3.2X400 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 29, 2011
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 22, 2010
FORFIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
PROTECTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·December 29, 2012
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