23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Calvary Spine Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
EarQ
FDA UDI
Oticon A/S·05707131353344·G40 S, MINIRITE 312 2.4G C094 EARQ
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL SB100II FINGER PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SJM TRIFECTA VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)·Product code LWR·November 11, 2015
HEART-VALVE, NON-ALLOGRAFT TISSUE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)·Product code LWR·November 11, 2015
HAMILTON-C6
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 26, 2016
DST SERIES EEA ORVIL 25MM DEVICE
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·October 17, 2008
OCTRODE 60-CM LENGTH PERCUTANEOUS LEADS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011
EONC
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 28, 2013
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 20, 2023
STEM: QUADRA-P COLLARED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 31, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 3, 2025
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·June 3, 2016
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025
AMISTEM-P COLLARED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 23, 2025
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·April 4, 2018