74 results · 28ms · Sources: EU EUDAMED, US FDA

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EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

FDA 510(k)
FDA Class 2 ·Immunology

BARCO MAMMO TOMOSYNTHESIS

FDA 510(k)
FDA Class 2 ·Radiology

MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 15, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 24, 2011

PRODISC-C VERTEBR-BODY RETAINER

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code LXH·June 17, 2013

AMISTEM-P COLLARED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 18, 2025

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 15, 2023

AMISTEM-P COLLARED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 25, 2021

AMISTEM-P

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021

LINER: VERSAFITCUP DOUBLE MOBILITY HC 48/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 27, 2021

VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·August 2, 2023

STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3

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

CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 15, 2021

BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·September 2, 2019

MPACT ACETABULAR SHELL 52 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·June 22, 2021