42 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultra OTC Facial Toning System
FDA 510(k)
FDA Class 2
·Neurology
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
FDA 510(k)
FDA Class 2
·Orthopedic
STERI-LUB LUBRICATION GEL
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 17, 2022
AMISTEM H, HA COATED STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2016
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 8, 2023
BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 16, 2023
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2026
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 26, 2026
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 3, 2008
OPTA PRO PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code LIT·July 28, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 14, 2022
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JDI·July 17, 2025
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 21, 2018
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 24, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 17, 2020
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 9, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 27, 2018
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 20, 2025