10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
e-Ortho Shoulder Software v1.1
FDA 510(k)
FDA Class 2
·Radiology
Ecosite Bond
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2207580·Light-curing single component bonding agent. Qu...
Nd: YAG Laser Therapy Systems HM-YL900
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
FDA 510(k)
FDA Class 2
·Immunology
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·March 2, 2020
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 30, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018