11 results
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19ms
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Sources: EU EUDAMED, US FDA
ANTISERUM TO HUMAN IGG
FDA 510(k)
FDA Class 2
·Immunology
LEONE SPA
FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515206014·Scredriver Handle 5 1/2", with key
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011790704010·dinamique m Bracket, +8°Torque, +9°Angulation, ...
Signature Ceramic Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
MULTILINK IMPLANT
FDA 510(k)
FDA Class 2
·Dental
SUREPATH PRESERVATIVE FLUID COLLECTION DEVICE
FDA Adverse Event
Other
·BD DIAGNOSTICS-TRIPATH·Product code MKQ·February 13, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025