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

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ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

QyScore Software

FDA 510(k)
FDA Class 2 ·Radiology

E.COM, SYMBIA E

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012

E.CAM

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

SYMBIA T-SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

E. CAM COMPUTER [510(K) K992731]

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SYSTEMS, INC.·Product code IYX·April 20, 2001

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 7, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·February 15, 2011

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·August 8, 2014

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024