13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KNOTILUS ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EXALIS
FDA UDI
GAMBRO DASCO SPA·07332414106126·Exalis is an integrated product able to acquire...
HHM
FDA UDI
Oticon A/S·05707131233882·K50, BTE 13 SGR HHM
NEO / Kinetic Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837036546·Kinetic Castroviejo Calipers
AIRCAST, MODEL #3011
FDA 510(k)
FDA Class 2
·Cardiovascular
REDONDO-L
FDA 510(k)
FDA Class 2
·Orthopedic
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 25, 2013
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·September 15, 2014
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 3, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021