57 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FETAL DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Working Tube
FDA UDI
ELLIQUENCE, LLC·00846338001841·
ROCKWOOD CLAVICLE PIN ASSEMBLY, SHORT
FDA UDI
Biomet Orthopedics, LLC·00887868449208·
ROCKWOOD CLAVICLE PIN ASSEMBLY, SHORT
FDA UDI
Biomet Orthopedics, LLC·00887868010811·
3I LOCATER ABUTMENT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
RENAISSANCE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 1, 2023
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
VERSAFITCUP CC TERMINAL CUP IMPACTOR
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MEH·June 4, 2014
NA
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 4, 2014
ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2018
VERSAFITCUP CC HIGHCROSS PE LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2013
VERSAFITCUP FLAT PE HC LINER Ø 36 / E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·April 26, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
GENESIS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 17, 2014
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·May 25, 2011
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017
STEM: AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 11, 2019
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·September 18, 2013