9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102183·ROWEN LASIK COMBINATION
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
HAMILTON-G5
FDA 510(k)
FDA Class 2
·Anesthesiology
CRANIOFACIAL RIGID FIXATION SYSTEM 1.2MM SCREW
FDA Adverse Event
Malfunction
·OSTEOMED·Product code DZL·October 15, 2014
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JGS·September 1, 2011
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022