12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIOPSY PIPETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Oticon
FDA UDI
Oticon A/S·05707131259844·RIA PRO, BTE 13 WL 100 CNB
EMVERA DIOLUX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTHROCARE ENT PLASMA WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 26, 2024
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·Product code NBW·May 29, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·May 11, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·January 12, 2019
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·January 12, 2019
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024