8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
IGM MININEPH ANTISERUM
FDA 510(k)
FDA Class 2
·Immunology
MASTERGRAFT PUTTY
FDA 510(k)
FDA Class 2
·Dental
Spectra S3 Plus
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·February 27, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 5, 2014
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·June 3, 2009
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024