387 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AOT Plus Direct Screw
FDA UDI
Truabutment Korea Co.,Ltd·08800076466845·
SAM EDELMAN
FDA UDI
Colors In Optics, Ltd.·00781268808705·Sunglasses
SAM EDELMAN
FDA UDI
Colors In Optics, Ltd.·00781268808859·Sunglasses
Circus by Sam Edelman
FDA UDI
Colors In Optics, Ltd.·00781268792165·Sunglasses
AOT Plus Direct Screw
FDA UDI
Truabutment Korea Co.,Ltd·08800076467040·
AOT Plus Direct Screw
FDA UDI
Truabutment Korea Co.,Ltd·08800076467149·
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW
FDA Recall
Terminated
·GN Hearing A/S Lautrupbjerg 7 Ballerup Denmark·Product code ESD·September 18, 2019
CONNECTA PLUS3 BLUE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·October 15, 2025
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW
FDA Enforcement
Class II
·Terminated·GN Hearing A/S·December 4, 2019
UNKNOWN KNEE CONSTRUCT ATTUNE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·July 24, 2025
BD CONNECTA PLUS3 BLUE
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 5, 2025
CONFIDENCE SPINAL CMT SYS, 11C
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code NDN·September 3, 2025
STERNUM BLADE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DWH·August 5, 2015
COLLINS RADIOPARENT BLADE
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF - RAYNHAM·Product code DWH·March 12, 2012
STERNUM BLADE
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code DWH·February 13, 2012
OSCILLATING AND SAGITTAL BLADE
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code DWH·February 9, 2012
COLLINS RADIOPARENT BLADE
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF - RAYNHAM·Product code DWH·March 12, 2012
STERNUM BLADE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DWH·June 30, 2014
STERNUM BLADE
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DWH·June 30, 2014
DUAL CUT SAGITTAL BLADE
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code DWH·February 22, 2010