12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINK MP RECONSTRUCTION PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
FDA 510(k)
FDA Class 2
·Cardiovascular
RII INFRARED EAR THERMOMETER,
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 5, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·May 26, 2011
SURGIFLO W. THROMBIN
FDA Adverse Event
Injury
·FERROSAN MEDICAL DEVICES A/S·Product code LMF·September 24, 2021
SURGIFLO W. THROMBIN
FDA Adverse Event
Injury
·FERROSAN MEDICAL DEVICES A/S·Product code LMF·September 24, 2021
DURAGEN DURAL GRAFT MATRIX
FDA Adverse Event
Injury
·INTEGRA - PRINCETON·Product code GXQ·February 25, 2022
DURASEAL, UNKNOWN
FDA Adverse Event
Injury
·INTEGRA - PRINCETON·Product code GXQ·February 25, 2022
DURAGEN DURAL GRAFT MATRIX
FDA Adverse Event
Injury
·INTEGRA - PRINCETON·Product code GXQ·February 25, 2022
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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