Abeon Medical Corporation

FDA Regulatory Profile

Abeon Medical Corporation appears in FDA public data with 3 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0686-2016, Class II) was initiated on November 25, 2015. Its most recent 510(k) clearance was granted on November 24, 2014.

Summary

Total Recalls
3
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0686-2016Class IIWilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE November 25, 2015
Z-0685-2016Class IITLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue reNovember 25, 2015
Z-0684-2016Class IITLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. November 25, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K142467IntelAir Nasal Airway Support SystemNovember 24, 2014
K131506AIRWAY SUPPORT SYSTEM / AIRPORTMarch 6, 2014