8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BICORE SMARTCATH INTRATRACHEAL CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515244450·Double Spoon Fcp, Pear Jaw, 100 degree
MIS ELECTROSURGICAL ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIMEADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 30, 2013
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-CLONMEL·Product code MAF·December 22, 2010
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 15, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015