7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CARDIOQUANT TROPONIN I TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Respire Pink AT (Hard, Hard/Soft, EF)
FDA 510(k)
FDA Class 2
·Dental
PLAS. STCK. W/EXTENSION TUBE/STERILE
FDA 510(k)
FDA Class 2
·General Hospital
DRILL,80K VISAO HANDPIECE 1/EA
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·March 7, 2013
INSYNC III PROTECT
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
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