Plasmapp Co,., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Plasmapp Co,., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette, Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
8
Total
8
Cleared
0
Denied
Plasmapp Co,., Ltd. has 8 FDA 510(k) cleared medical devices. Based in Daejeon, KR.
Last cleared in 2023. Active since 2021. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Plasmapp Co,., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by CardioMed Device Consultants, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Plasmapp Co,., Ltd.
8 devices
Cleared
May 25, 2023
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for...
General Hospital
30d
Cleared
May 09, 2023
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
General Hospital
222d
Cleared
May 09, 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators...
General Hospital
222d
Cleared
May 09, 2023
Tyvek Roll with CI for STERLINK Sterilizer
General Hospital
222d
Cleared
Apr 14, 2023
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for...
General Hospital
431d
Cleared
Oct 22, 2021
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators...
General Hospital
100d
Cleared
Oct 22, 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
General Hospital
100d
Cleared
Oct 22, 2021
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
General Hospital
100d