75 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straumann cerabone
FDA 510(k)
FDA Class 2
·Dental
C-THV SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PONTO PRO POWER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LOW PRESSURE BLACK MAX HANDPIECE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 15, 2014
STRAIGHT SUCTION, AXIEM¿
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
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