49 results · 24ms · 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.

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

M5 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

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

BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 21, 2013

ARTICULEZE M HEAD 36MM +5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·September 26, 2014

RADIOASSAY, VITAMIN B12

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CDD·June 14, 2011

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

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 5, 2024

VERSAFITCUP FLAT PE HC LINER Ø 32/E

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2016

STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·February 28, 2020

AMISTEM H CEMENTLESS STEM #4 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·February 9, 2015

CUP: VERSAFITCUP ACETABULAR SHELL 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 3, 2020

BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2020

VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·June 15, 2022