12 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Ahmed Glaucoma Valve Model FP8
FDA 510(k)
FDA Class 2
·Ophthalmic
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
TATTOOSTAR Y
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 14, 2014
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
SPINAL INJECTION SYSTEM
FDA Adverse Event
Malfunction
·LAURIMED LLC·Product code BSP·September 4, 2008
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
GAMMA PROBE COVER
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code KKX·April 23, 2018
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 20, 2015
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 21, 2015
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021