11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ADT BONE MARROW BIOPSY-ASPIR. NEELDE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006991·VITROS FS Diluent Pack 2
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133550·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756016629·ARM SLING WITH
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 13, 2025
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022