10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Picasso Pro Diode Laser (002-00460)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Estremo Fibular Nail
FDA 510(k)
FDA Class 2
·Orthopedic
Dexter L6 System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 29, 2018
INSIGNIA ULTRA
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DXY·November 11, 2008
SPEEDBAND SUPERVIEW SUPER 7¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·September 19, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 24, 2015
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025