12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Geniant Cranial (Navigated Neurosurgical Positioning Robot)
FDA 510(k)
FDA Class 2
·Neurology
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES (USA) TITANIUM WIRE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cflex Reduce Full Leg LG LG LG Tall Left Beige
FDA UDI
SIGVARIS INC·00745129331634·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg LG LG LG Tall Right Beige
FDA UDI
SIGVARIS INC·00745129331719·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg LG LG LG Reg Left Beige
FDA UDI
SIGVARIS INC·00745129331672·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg LG LG LG Reg Right Beige
FDA UDI
SIGVARIS INC·00745129331757·Inelastic garment (or accessory) made of nylon ...
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 10, 2014
CCU BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 2, 2011
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024