9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Symmetry Surgical®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482034835·Symmetry® Retractor, B.E. Glass Abdominal, 10 in
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962114827·B.E. GLASS ABDOMINAL RETRACTOR, 9 3/4"
Phasix ST Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
FDA 510(k)
FDA Class 2
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 11, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 12, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 23, 2013
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024