9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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(QUANTA SYSTEM) SURGICAL LASER FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Spherodon +
FDA UDI
SILMET LTD·07290012207563·Dental Amalgam Capsules
BD SYRINGE 3ML LL 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 22, 2024
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
RATIONAL IMAGING PACS
FDA 510(k)
FDA Class 2
·Radiology
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 10, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015