22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
METAL TRANSCEND ARTICULATION SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Duesseldorf Type AERIAL Total Titanium
FDA UDI
Heinz Kurz GmbH·EHKM10040431·Ossicular Prosthesis, total
artegral life HD
FDA UDI
Merz Dental GmbH·D7092004043·artegral life HighDefinition posterior lower -M...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776398446·Debakey Bayonet Forceps, 9 1/2", 1.5mm tip, str...
SCANLAN® Miscellaneous Instruments
FDA UDI
SCANLAN INTERNATIONAL INC·00846159020175·DEBAKEY FORCEPS BAYONET SHAPED SHANKS 1.5MM TIP...
NA
FDA UDI
STRYKER CORPORATION·04546540790910·3.2MM DRILL PIN
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 12, 2023
DRG AURICA ELISA TESTOSTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD NANO¿ 2ND GEN PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 30, 2023
LVP PRIMARY ADMIN SET 2 INLET AND YSITE
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FPA·June 21, 2024
LVP PRIMARY ADMIN SET 2 INLET AND YSITE
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FPA·June 21, 2024
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 14, 2024
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 12, 2023
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·February 27, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·September 16, 2024
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 19, 2013
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·February 23, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·February 27, 2008
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025