27 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128145·30-40 MV FOR MEN SEL CALF STD TAN VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125823·30-40 MV FOR MEN CLSC CALF STD TAN VII
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117377·Modular Knee Stem Pilot 13mm x 75mm
SAFETY BIOPSY NEEDLE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WILSON-COOK USW CAP AND WIRE LOCK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 2, 2021
PEN NDL 32G 4MM PRO 100 BOX FR
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 6, 2025
LUNDERQUIST SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 13, 2026
RUSCH GREENSPEC FO HANDLE SMALL
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CCW·October 29, 2014
RENEGADE¿ HI-FLO¿ FATHOM¿ KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·September 9, 2011
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·July 18, 2013
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 11, 2026
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·March 20, 2026
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·February 26, 2024
AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·November 26, 2025
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·November 27, 2025
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·September 5, 2025
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·January 3, 2023