74 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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