Medical Device Manufacturer · NZ , Airport Oaks

Aroa Biosurgery , Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2018

Recent clearances: Endoform Reconstructive Template - PLGA, Endoform Dental Membrane, Enivo™

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8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Aroa Biosurgery , Ltd. General & Plastic Surgery ✕

7 devices
1-7 of 7
Cleared Jun 24, 2026
Endoform Dermal Template
K260669 · KGN
General & Plastic Surgery · 114d
Cleared Jun 03, 2025
Endoform Reconstructive Template - PLGA
K250598 · FTM
General & Plastic Surgery · 95d
Cleared Apr 07, 2023
Enivo™
K223373 · BTA
General & Plastic Surgery · 154d
Cleared Mar 31, 2021
Myriad Particles
K200502 · KGN
General & Plastic Surgery · 397d
Cleared Jul 29, 2020
Symphony
K200413 · KGN
General & Plastic Surgery · 161d
Cleared Apr 11, 2019
Endoform Restella
K183398 · FTM
General & Plastic Surgery · 125d
Cleared Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
K181935 · FTL
General & Plastic Surgery · 138d
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