21 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 3000 NUCLEAR CAMERA
FDA 510(k)
FDA Class 1
·Radiology
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 1, 2026
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011882312220·dentaform® Band, tooth 16, size 12/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011882312180·dentaform® Band, tooth 16, size 12/Roth 18
Zyppah Anti-Snoring Device
FDA 510(k)
FDA Class 2
·Dental
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
FDA 510(k)
FDA Class 2
·Cardiovascular
COBAS C 303 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 6, 2026
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 1, 2025
COBAS C 303 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 17, 2026
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 16, 2025
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 31, 2025
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 22, 2025
COBAS C 303 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·February 2, 2026
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 18, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO., KG·Product code NVZ·October 22, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 20, 2012
Basic Tray, part number PSS1559(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 14, 2026
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 30, 2026
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 12, 2026