21 results · 29ms · Sources: EU EUDAMED, 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