11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
FDA 510(k)
FDA Class 2
·Neurology
SANSIBAR CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SIDEPORT PINCH CLAMP DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017
NEWPORT
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
UNKNOWN
FDA Adverse Event
Injury
·Product code LZS·May 9, 2008
Cook
FDA UDI
COOK INCORPORATED·00827002134447·Gastrojejunostomy Feeding Tube Ultrathane
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018