17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433118·Integra® Jarit® Knife Handle No. 4, 5-3/8", Hol...
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·June 7, 2005
CALEX CONDITIONER
FDA 510(k)
FDA Class 2
·Dental
ASCENSION ANKLE FUSION PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRIDENT PSL HA CLUSTER 54MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·May 19, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013
UNIVERSAL OSCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A·Product code GFA·September 11, 2014
PEDIASAT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 17, 2023
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025