10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SECUTEX WRIST BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine
CARESCAPE B450
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIO TRANSPARENT ECG ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 5, 2014
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 15, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 2, 2010
GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code JQP·September 22, 2008
Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code JQP·November 17, 2008
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.
FDA Recall
Terminated
·GE Healthcare It·Product code JQP·November 20, 2012
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