13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IFUSE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925028234·SUCTION/SPECULUM MODULE (BASE ONLY)
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·October 9, 2013
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
STEALTHSTATION® S7´
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019
ENDOPATH XCEL TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 1, 2014
SOFTHEAT
FDA Adverse Event
Injury
·KAZ, INC.·Product code IRT·May 14, 2013
DA+ T SERIES DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·September 15, 2014
Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 6, 20 mm; Ref 96-2764.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005