17 results · 20ms · Sources: EU EUDAMED, US FDA

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SANDARE CYANMETHEMOGLOBIN STANDARD

FDA 510(k)
FDA Class 2 ·Hematology

Pressure Therapy System PT1003

FDA 510(k)
FDA Class 2 ·Physical Medicine

ETHYLENE OXIDE STERILI. INDICATOR

FDA 510(k)
FDA Class 2 ·General Hospital

ROUND FILTERS W/INDICATOR

FDA Adverse Event
Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

COBAS E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 7, 2024

COBAS E 411 ANALYZER (RACK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 2, 2024

COBAS E 411 ANALYZER (RACK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 3, 2024

COBAS E 411 ANALYZER (DISK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 27, 2025

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 10, 2014

*

FDA Adverse Event
Malfunction ·UNK·Product code HRX·September 17, 2012

CAPSURE EPI

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DTB·August 11, 2010

COBAS E 411 ANALYZER (DISK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 2, 2024

COBAS E 411 ANALYZER (RACK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 2, 2025

FULL-SIZE LID W/RETENTION PLATE SILVER

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code FRG·March 10, 2016

COBAS E 411 ANALYZER (RACK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 5, 2025

COBAS E 411 ANALYZER (DISK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 31, 2025

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015