11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIBRI-PREST AUTOMATE HA34
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
ULTRASONIC MESH NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
NOVASURE
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·May 22, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·June 28, 2012
VALLEY LAB
FDA Adverse Event
Malfunction
·VALLEY LAB, DIVISION OF TYCO HEALTH CARE GROUP·Product code GEI·September 15, 2010
Various Angiography/Cath Lab packs/trays
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Various Pacemaker Packs, Cardio Thoracic Packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various hysterectomy, vaginal packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018