7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Elecsys Phospho-Tau (181P) Plasma
FDA 510(k)
FDA Class 2
·Immunology
ADVIA IMS GLUCOSE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RENASYS GO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
TEBBETTS FIBEROPTIC SS RETRACTOR
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code GAD·November 25, 2008
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 25, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024