13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
Legacy™4 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307103325·4.2mmD x 11.5mmL, 3.5mmD Platform
CONCISE LIGHT CURED WHITE SEALANT
FDA 510(k)
FDA Class 2
·Dental
LEAP FROG
FDA 510(k)
FDA Class 2
·Cardiovascular
HARMONIC SCALPE CURVED SHEARS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 19, 2014
ARTERIAL LINE KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQX·June 11, 2010
SMALL BATTERY DRIVE (COLIBRI)
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·July 1, 2015
Various neurology packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various PICC Line, Central Line Packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various Laparoscopy Packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various Angiography packs/trays
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020