10 results
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20ms
·
Sources: EU EUDAMED, US FDA
DIALYZER, HF 130 HOLLOW FIBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ceramill® Zolid
FDA UDI
Amann Girrbach AG·E4947602521·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110652·COAXIAL IRR-ASP TIP 45 DEG W/ SILICONE
Straumann ZOLID-HT
FDA UDI
Amann Girrbach AG·E494760252STM1·
OmniPod Insulin Management System
FDA 510(k)
FDA Class 2
·General Hospital
KIT, PREP SHAVE
FDA 510(k)QUICK COUPLING FOR K-WIRES
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·April 19, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·May 8, 2015
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014