9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IV FILTER EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
G.USBAMP
FDA 510(k)
FDA Class 2
·Neurology
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014
SCREW
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 6, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010
PLATE GC LECT AGAR 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JTY·March 29, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014