12 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CLAREON MONARCH IV IOL Delivery System
FDA 510(k)
FDA Class 1
·Ophthalmic
LuxaCore® Smartmix Dual
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2120390·Core build-up composite. Core buildups and post...
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
FDA 510(k)
FDA Class 2
·Dental
Honorst Implant System
FDA 510(k)
FDA Class 2
·Dental
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 8, 2013
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025