11 results
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36ms
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Sources: EU EUDAMED, US FDA
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
FDA 510(k)
FDA Class 1
·Anesthesiology
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917022413·Personal Use Kit OC-Auto, for Martinsburg, WV
UNO EWIS BLUE 60/9 HCAP 5-PACK CA
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 18, 2024
FSH IRMA IMMUNOMAG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
FDA 510(k)
FDA Class 2
·Anesthesiology
DURASUL, ALPHA INSERT, LL/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·December 1, 2017
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 15, 2015
IDENTITY XL DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·January 15, 2014
5MM SILS PORT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GCJ·December 6, 2012
RSP SHOULDER
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code LXH·February 26, 2015
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015