23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M5T INSTANT FEVER THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890122170·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450249765·
IMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033366264·
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187006·Battalion, LLIF Trial, 10°, 22 mm Wide, 17 mm X...
IMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033366257·
IMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033366226·
IMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033366240·
IMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033366233·
BD DISCARDIT II 10 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 25, 2021
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 17, 2025
4 PORT, 4 WAY STOPCOCK
FDA 510(k)
FDA Class 2
·General Hospital
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
FDA 510(k)
FDA Class 1
·General Hospital
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 4, 2025
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·February 2, 2015
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·February 1, 2011
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019