11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3000 INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981081140·Cannulated Tap 5.0mm, Modular (for 5.5mm Screw)
ARROW REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 50ML 18G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·September 25, 2020
AU680 CHEMISTRY ANALYZER WITH ISE
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 11, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010
THINLINE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 3, 2014
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
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