12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFY SERIES: EV-804, EV-805 & EV-806
FDA 510(k)
FDA Class 2
·Neurology
Australis ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127732·
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EZ SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 25, 2021
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code BTI·April 22, 2013
SELECTA II
FDA Adverse Event
Injury
·LUMENIS, INC.·Product code GEX·April 28, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018