9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LunaGuard Nighttime Dental Protector
FDA 510(k)
FDA Unclassified
·Unknown
9.1MHZ Pencil Probe 7FT Contoured
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787024227·
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
FDA 510(k)
FDA Class 2
·Hematology
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 21, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 25, 2011
FLIPCUTTER II, SHORT, 9 MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MDM·May 12, 2017
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018