Kci USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Kci USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10), ACTIV.A.C. Negative Pressure Wound Therapy System, V.A.C. DERMATAC Drape
28
Total
27
Cleared
1
Denied
Kci USA, Inc. has 27 FDA 510(k) cleared general & plastic surgery devices. Based in San Antonio, US.
Latest FDA clearance: May 2024. Active since 2006.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Kci USA, Inc.
28 devices
Cleared
May 23, 2024
3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
General & Plastic Surgery
29d
Cleared
Jul 08, 2020
ACTIV.A.C. Negative Pressure Wound Therapy System
General & Plastic Surgery
27d
Cleared
May 18, 2020
V.A.C. DERMATAC Drape
General & Plastic Surgery
90d
Cleared
Nov 22, 2019
PREVENA PLUS Incision Management System (No Ag)
General & Plastic Surgery
249d
Not Cleared
Apr 19, 2019
PREVENA 125 and PREVENA PLUS 125 Therapy Units
General & Plastic Surgery
400d
Cleared
Mar 28, 2019
V.A.C. DERMATAC Drape
General & Plastic Surgery
294d
Cleared
Mar 20, 2019
ACTIV.A.C. Therapy Unit
General & Plastic Surgery
90d
Cleared
Feb 15, 2019
PREVENA RESTOR(TM) Incision Management System
General & Plastic Surgery
253d
Cleared
Jun 01, 2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management...
General & Plastic Surgery
60d
Cleared
Mar 09, 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management...
General & Plastic Surgery
127d
Cleared
Mar 02, 2018
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA...
General & Plastic Surgery
116d
Cleared
Dec 09, 2016
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
General & Plastic Surgery
291d