62 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 30, 2024
LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·August 30, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014
PELVICOL 6 X 8 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 28, 2011
MPACT DOUBLE MOBILITY SHELLS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·November 10, 2025
STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 20, 2021
LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 6, 2021
LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 25, 2023
LINER: MPACT DOUBLE MOBILITY HC LINER 28/DMD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 2, 2023
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 23, 2018
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 7, 2023
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 4, 2021
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·February 21, 2025
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
MPACT DOUBLE MOBILITY SHELLS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·November 21, 2025