13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spider Cervical Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRAPRO PLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESTECH COBRA BIPOLSR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
MONTERIS MEDICAL NEUROBLATE SYSTEM
FDA Adverse Event
Malfunction
·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015
CAPSURE SP NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·June 14, 2013
UNKNOWN
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·July 5, 2011
TDXFLX VANCOMYCIN REAGENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INT'L, LTD·Product code LEH·September 24, 2008
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021
TERUMO PROGREAT CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024