536 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SUPERSTITCH 5F, 12F, AND EL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PINS AND WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
OPUS MAGNUM ANCHOR & INSERTER
FDA 510(k)
FDA Class 2
·Orthopedic
2520274-2013-062125
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·September 6, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 16, 2013
TURON SHOULDER INSTRUMENT
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code HTQ·March 17, 2011
ACCU-CHEK MULTICLIX LANCETS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code FMK·June 18, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001484;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 20, 2011
OT ULTRA METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 3, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 27, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 3, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 6, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 1, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 16, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 19, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 22, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 30, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 2, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 12, 2011