35 results · 23ms · Sources: EU EUDAMED, US FDA

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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