45 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551144182·TWO PIECE BUSHING FOR VERTEK AND BRAINLAB SEEG ...
BEL-CAT
FDA 510(k)
FDA Class 2
·Radiology
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020
GALAXY G3 MINI 1MM X 2CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2020
AMISTEM H, HA COATED STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2016
BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 16, 2023
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2026
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 26, 2026
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 25, 2011
LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 14, 2022
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JDI·July 17, 2025
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 21, 2018
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 24, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 17, 2020
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 9, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 27, 2018