20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COROENT THORACOLUMBAR IMPLANTS
FDA 510(k)
FDA Class 2
·Orthopedic
ForPro
FDA UDI
Tng Worldwide, Inc.·00672047101189·Black Nitrile Glove
Size S
100t
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973936·UniTip High Resolution Catheter 14F
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970959·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970935·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970942·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970911·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973028·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973806·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973240·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970966·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970928·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970973·
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 3, 2014
MAXIM CONSTRAINED TIBIAL BEARING 10X79/83
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 31, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 27, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 3, 2019
PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014