8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MYRINGOTOMY KNIFE (VARIOUS TYPES)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788221620·TLIF Trial 14x10x32
AGGREGUIDE
FDA 510(k)
FDA Class 2
·Hematology
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2014
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 7, 2012
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·June 5, 2015
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