22 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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CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
FDA 510(k)
FDA Class 2
·Neurology
XANTALGIN CRONO
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 14, 2025
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2019
VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017
VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·June 22, 2018
AMISTEM H, HA COATED STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2017
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 9, 2021
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2024
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2019
CAPSURE SENSE
FDA Adverse Event
Death
·MPRI·Product code DTB·April 23, 2013
AU681-02E CHEMISTRY ANALYZER
FDA Adverse Event
Injury
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 1, 2011
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 29, 2023
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·October 16, 2020
QUADRA S FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 6, 2025
VERSAFITCUP DM ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015
STEM: AMISTEM H HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 5, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012