7 results
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26ms
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Sources: EU EUDAMED, US FDA
DIALYZER REPROCESSING SYSTEM DRS-4
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITEK 2 AST-ST CEFOTAXIME
FDA 510(k)
FDA Class 2
·Microbiology
BARRIER TOWEL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·May 20, 2014
DERMABOND ADVANCED
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MPN·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