32 results · 44ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

16ch Foot/ Ankle SPEEDER

FDA 510(k)
FDA Class 2 ·Radiology

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENSITE VERISMO SEGMENTATION TOOL V.2.0

FDA 510(k)
FDA Class 2 ·Radiology

QUICK FLEX LV LEAD

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·July 27, 2011

ASCENDRA DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2013

SOFTCLIX PLUS LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 30, 2008

BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2024

VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 5, 2025

BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023

VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022

CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2020

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2023

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·February 11, 2025

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 12, 2026

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 10, 2020

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 24, 2020

INVICTUS SPINAL FIXATION SYSTEM

FDA Adverse Event
Injury ·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025

CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022