12 results
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19ms
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Sources: EU EUDAMED, US FDA
CHLAMYDIAZYME BLOCKING REAGENT
FDA 510(k)
FDA Class 1
·Microbiology
V. Mueller
FDA UDI
CAREFUSION 2200, INC·10885403156007·DIAMOND-LINE® GRASPER INSULATED DEBAKEY 26CM (...
BioZorb SP Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SWIFT-LOCK ANCHOR, MODEL 1192
FDA 510(k)
FDA Class 2
·Neurology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 23, 2018
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·June 24, 2014
ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
FDA Adverse Event
Death
·COOK, INC.·Product code MIH·November 5, 2010
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 2012
Pressure Monitoring Set, C-PMS, G02838
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 10, 2020
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA Enforcement
Class II
·Completed·Cook Incorporated·July 20, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024