35 results
·
23ms
·
Sources: EU EUDAMED, US FDA
FilmArray Blood Culture Identification (BCID) Panel
FDA 510(k)
FDA Class 2
·Microbiology
INFILTRATION KIT
FDA 510(k)
FDA Class 2
·Dental
ADVANCED GLASS IONOMER (K-130) RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
FDA Adverse Event
Injury
·ZEST ANCHORS, INC.·Product code DZE·June 14, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
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
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 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