22 results
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19ms
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Sources: EU EUDAMED, US FDA
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482134·BONE SCREW 6860055 SELF TAPPING 4.5X15MM
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153161936·SCREWDRIVER BLADE, HEX-FIT
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005516·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005509·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 9...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005514·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005511·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005512·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005510·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005508·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 8...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005515·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005513·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 1...
FOUNDATION System
FDA UDI
CORELINK LLC·M72586005507·FOUNDATION LATERAL FLAT CAGE - 16MM X 55MM X 7...
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KODAK PACS
FDA 510(k)
FDA Class 2
·Radiology
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
7.3MM CANNULATED SCREW 32MM THREAD/115MM
FDA Adverse Event
Malfunction
·Product code HWC·November 1, 2012
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 17, 2010
LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-Standard Child w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in Compact Case; 860055-Pediatric Complete in Display Case; 860056-Standard Term-Baby w/Infant Mask 0-1 in Carton; 865500-Pediatric Upgrade Kit . Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
FDA Recall
Terminated
·Laerdal Medical Corporation·Product code BTM·December 23, 2003
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025