Terragene S.A. is one of 7 FDA 510(k) medical device manufacturers from Argentina in the dataset, ranked by real submission volume.
Terragene S.A. - FDA 510(k) Cleared Devices
Recent clearances: Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2), Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40), Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
8
Total
7
Cleared
1
Denied
Terragene S.A. has 7 FDA 510(k) cleared medical devices. Based in Rosario, AR.
Latest FDA clearance: Dec 2024. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Terragene S.A. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Licensale, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Terragene S.A.
8 devices
Cleared
Dec 12, 2024
Terragene® Bionova® Photon Process Challenge Device with unique-point...
General Hospital
115d
Cleared
Sep 18, 2024
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene®...
General Hospital
495d
Not Cleared
Jul 12, 2024
Terragene Bionova Photon Biological Indicator (BT225)
General Hospital
742d
Cleared
Apr 05, 2024
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene®...
General Hospital
266d
Cleared
Feb 28, 2023
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova®...
General Hospital
267d
Cleared
Jun 30, 2020
Terragene Chemdye
General Hospital
147d
Cleared
Sep 13, 2019
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape,...
General Hospital
149d
Cleared
Nov 02, 2017
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R)...
General Hospital
314d