ClearanceBrief
Company ยท US

Abeon Medical Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2014. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2
FFORetractor, Self-Retaining2
KNTTubes, Gastrointestinal (And Accessories)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 24, 2014K142467IntelAir Nasal Airway Support System
Abeon Medical Corporation
CCK
Mar 6, 2014K131506AIRWAY SUPPORT SYSTEM / AIRPORT
Abeon Medical Corporation
CCK

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 25, 2015Abeon Medical Corporation
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
Terminated		 KNTNone listed
Nov 25, 2015Abeon Medical Corporation
TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Terminated		 FFONone listed
Nov 25, 2015Abeon Medical Corporation
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Terminated		 FFONone listed
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