8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TERUMO SENSIBEAD EIA HPRL KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ABBOTT LIFECARE 500 INFUSER
FDA 510(k)
FDA Class 2
·General Hospital
TOXOSCAN CARD TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 6, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 5, 2010
UNK - -IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 30, 2012
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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