12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Millipede 088 Access Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
inCoris ZI
FDA UDI
SIRONA Dental Systems GmbH·E27662318022·inCoris ZI meso F0.5 S 1 Piece
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CORIX 70 PLUS-USV
FDA 510(k)
FDA Class 2
·Dental
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014
RESOLUTION II CLIP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·September 1, 2011
PLV-102
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022