11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CerOX
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131286659·RIA2 PRO, RITE 312 WL SGR
IRIS Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837060862·CERVICAL PLATE BENDER
Femoral Trial Size 4
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073671·
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 7, 2022
FORCETRIAD ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 29, 2013
LAMITRODE 4 LEAD KIT, 90CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 14, 2015
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024