7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
FDA 510(k)
FDA Class 2
·General Hospital
CHEM-STAT ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IOCARE IRRIGATION & ASPIRATION PACK
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 8, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 24, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022