7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
1URO-LOG HOME DIAGNOSTIC PACK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MYCOPLASMA PNEUMONIAE CF ANTIGEN
FDA 510(k)
FDA Class 1
·Microbiology
HAEMOPHILUS I.D. II TRIPLATE
FDA 510(k)
FDA Class 1
·Microbiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2014
UNSPECIFIED SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQE·November 8, 2012
OXFORD UNI PHASE 3 ANATOMIC MENISCAL BEARING LEFT LARGE
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·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