183 results
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22ms
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Sources: EU EUDAMED, US FDA
NAVIGATOR I
FDA 510(k)
FDA Class 2
·Physical Medicine
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032879·Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs B...
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488003412·PORT ACCESS TRAY
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
FDA 510(k)
FDA Class 2
·General Hospital
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 29, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 9, 2019
MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 8
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 22, 2019
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·March 29, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 29, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·April 23, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 12, 2016
CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·June 14, 2019
COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023
MPACT FLAT PE HC LINER Ø28/B
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·January 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014