8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGITEKS PERCUTANEOUS ANTEGRADE ALL -
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
APTUS BLUE
FDA 510(k)
FDA Unclassified
·Unknown
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 13, 2012
CONSERVE(R) TOTAL HEAD
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 23, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018