10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Neutral
FDA UDI
Sbo Hearing A/S·05714464034666·RemoteLink Connect 3.4.0 Android
ELMED
FDA UDI
ELMED INCORPORATED·00842180163386·Double-Handed Bone Curette, 5/8" (15 mm) x 1 1/...
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 13, 2020
MIROMATRIX BIOLOGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESCAN
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 29, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
SYSTEM 2000
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code ILM·July 11, 2013
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
FDA Enforcement
Class II
·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019