31 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PeriView FLEX
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PMC LAPAROSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
SHER-I-BRONCH LS ET TUBE 35 FR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·July 7, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 30, 2008
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2024
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Metrology Inc·February 7, 2018
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
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
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022