8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ELECTRODE, PACEMAKER, PERMANENT
FDA 510(k)
FDA Class 3
·Cardiovascular
ZURICH DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CURVE IMAGE
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 2, 2015
PREMIUM SURGICLIP S-9.0 TITANIUM
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDO·August 17, 2010
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018