9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122987·K-WIRE - SINGLE TROCAR 1.25mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123007·K-WIRE - SINGLE TROCAR 1.6mm DIA x 150mm
IPACS ORTHO
FDA 510(k)
FDA Class 2
·Radiology
VIDEO BRONCHOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 31, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·December 29, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·July 17, 2014
PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. 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