7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
A O MICROSCOPE VIDEO SYSTEM
FDA 510(k)
FDA Class 1
·Pathology
ZOLL RESCUENET 12-LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
BTL-094
FDA 510(k)
FDA Class 1
·Physical Medicine
32MM DIA COCR MOD HEAD +12MM NK
FDA Adverse Event
Injury
·.·Product code JDI·May 20, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·November 6, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 31, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022