9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OASYS System
FDA 510(k)
FDA Class 2
·Orthopedic
ENTERAL FEEDING BAG AND SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXOGUARD NERVE CONNECTOR AND PROTECTOR
FDA Adverse Event
Injury
·COOK BIOTECH·Product code JXI·October 24, 2019
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
DELTEC COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITH MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·August 27, 2008
VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·October 4, 2017
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