12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581272·Split Tube Retractor Ø18x40 mm
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNKNOWN STRATA VALVE
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·September 26, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
CAPSUREFIX
FDA Adverse Event
Death
·MPRI·Product code DTB·June 3, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
ATTUNE CR RP INSRT SZ 9 16MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·August 28, 2024
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·February 19, 2020