13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PBN DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROTEIN ASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PINNACLE3 SMARTARC
FDA 510(k)
FDA Class 2
·Radiology
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811931·STEM COMPACTOR SIZE 2
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811955·STEM COMPACTOR SIZE 4
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811962·STEM COMPACTOR SIZE 5
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811948·STEM COMPACTOR SIZE 3
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811924·STEM COMPACTOR SIZE 1
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556919354·STEM COMPACTOR SIZE 0
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 5, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
ENRHYTHM MRI
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·August 8, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026