12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable medical surgical mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T-MAT L/RA Film
FDA UDI
CARESTREAM HEALTH, INC.·40889975212094·100 SH T-MAT L/RA 20X40CM NI
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319753842·Varady Phlebectomy Hook 6-3/4" (16.9cm), micro ...
VORTEX
FDA 510(k)
FDA Class 2
·Radiology
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
FDA 510(k)
FDA Unclassified
·Unknown
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·October 24, 2008
TRIDENT 0 INSERT TRIAL 32MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 8, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Ingenuity TF PET/CT 882442
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021