28 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028213·
CT/MR Ring & Tandem Set, 26mm, 60ø, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330022554·
SYNCARDIA 70CC TAH-T
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, LLC·Product code LOZ·August 1, 2016
CT/MR R&T Ring Tube, 60ø, 26mm ring only, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330022561·
HANSATOME MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
GELBFISH FLEX VASCULAR DILATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
VELYS ARRAY SET KNEE
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code OLO·August 13, 2024
ATTUNE CR FEM TRIAL SZ 7 RT
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code HWT·September 24, 2025
ATTUNE SHIMS & GEN INST
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code FSM·January 27, 2026
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 15, 2014
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·May 16, 2011
XP-CR Tibial Tray - Interlok 83 mm Item # 195277
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BASEPLATE INSERTER ROD
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code LXH·January 16, 2025
BASEPLATE INSERTER ROD
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code LXH·August 26, 2024
VELYS SAW BLADE
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code OLO·November 18, 2025
DPS AL CASE FULL MID HEIGHT
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code FSM·September 2, 2025
BASEPLATE INSERTER ROD
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code LXH·December 19, 2024
ATTUNE CR FEM TRIAL SZ 6 RT
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code HWT·February 26, 2026