21 results
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20ms
·
Sources: EU EUDAMED, US FDA
Vesalio Peripheral System
FDA 510(k)
FDA Class 2
·Cardiovascular
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00613994803733·SHUNT 25131-2 INTL ONLY DELTA SM 2.0
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169472778·SHUNT 25131-2 INTL ONLY DELTA SM 2.0
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00763000028893·SHUNT 25131-2 INTL ONLY DELTA SM 2.0
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946020392·MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPOC, PVI &...
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946020026·Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, SPM...
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946080600·PROPAQ M, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, ...
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946080518·PROPAQ M, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, ...
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946080563·PROPAQ M, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, ...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295438809·ATTUNE KNEE SYSTEM REVISION PRESS-FIT STEM TRIA...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295438793·ATTUNE KNEE SYSTEM REVISION PRESS-FIT STEM TRIA...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295438786·ATTUNE KNEE SYSTEM REVISION PRESS-FIT STEM TRIA...
VerteLP Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
FDA 510(k)
FDA Class 2
·Cardiovascular
PROPAQ M
FDA UDI
Zoll Medical Corporation·00847946029401·MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPOC, PVI &...
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·September 13, 2011
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 3, 2008
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 29, 2013
MEDSYTEM III INFUSION PUMP
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·July 21, 2021
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0, 25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5, 27219-1 - VALVE 27219-1 NEONATE DELTA, 27219-2 - VALVE 27219-2 NEONATE DELTA, 27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP, 27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0, 27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0, 27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5, 42812 - VALVE 42812 DELTA SMALL LEVEL I, 42813 - VALVE 42813 DELTA SMALL LEVEL 1.5, 42814 - VALVE 42814 DELTA SMALL LEVEL II, 42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP, 42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5, 42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP, 46812 - ASSY 46812 DELTA SHUNT SMALL PL 1, 46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5, 46822 - ASSY 46822 DELTA SHUNT REG P/L 1, 46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5, 46824 - ASSY 46824 DELTA SHUNT REG P/L 2, 46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1, 46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5, 46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2, 92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0, 92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,
FDA Enforcement
Class II
·Ongoing·Medtronic Neurosurgery·February 24, 2021