57 results · 21ms · Sources: EU EUDAMED, US FDA

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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