KCI USA, Inc

FDA Filings

This page includes the latest FDA filings for KCI USA, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
KCI USA, Inc.
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)2019-11-22
KCI USA, Inc.
V.A.C. DERMATAC Drape2019-03-28
KCI USA, Inc.
ACTIV.A.C. Therapy Unit2019-03-20
KCI USA, Inc.
PREVENA RESTOR(TM) Incision Management System2019-02-15
KCI USA, Inc.
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System2018-06-01
KCI USA, INC.
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System2018-03-09
KCI USA, Inc.
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit2018-03-02
KCI USA, Inc.
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System2016-12-09
KCI USA, INC. (KINETIC CONCEPTS, INC.)
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems With PEEL & PLACE Dressings2016-10-04
KCI USA, INC.
Prevena Plus Incision Management System Kit With Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit With Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack2016-02-29
KCI USA, INC. (KINETIC CONCEPTS, INC.)
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U2010-09-17

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
KCI USA, Inc.
PREVENA 125 And PREVENA PLUS 125 Therapy Units2019-04-19

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
SNAP™
KCI USA, INC.2019-10-07
SNAP™
KCI USA, INC.2019-10-07
V.A.C. DERMATAC™
KCI USA, INC.2019-10-07
SNAP™
KCI USA, INC.2019-10-07
PREVENA PLUS™ PEEL & PLACE™
KCI USA, INC.2019-09-18
PREVENA DUO™ PEEL & PLACE™
KCI USA, INC.2019-09-18
V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING
KCI USA, INC.2019-07-23
V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING
KCI USA, INC.2019-07-23
V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING
KCI USA, INC.2019-07-23
PREVENA RESTOR™ ARTHRO•FORM™
KCI USA, INC.2019-07-11
PREVENA RESTOR™ ARTHRO•FORM™
KCI USA, INC.2019-07-11
PREVENA RESTOR™ BELLA•FORM™
KCI USA, INC.2019-07-11
PREVENA RESTOR™ BELLA•FORM™
KCI USA, INC.2019-07-11
PREVENA RESTOR™ BELLA•FORM™
KCI USA, INC.2019-07-11
V.A.C.ULTA™
KCI USA, INC.2019-06-07
PREVENA RESTOR™ ARTHRO•FORM™
KCI USA, INC.2019-05-06
PREVENA RESTOR™ ARTHRO•FORM™
KCI USA, INC.2019-05-06
PREVENA RESTOR™ BELLA•FORM™
KCI USA, INC.2019-05-06
PREVENA RESTOR™ BELLA•FORM™
KCI USA, INC.2019-05-06
PREVENA RESTOR™ BELLA•FORM™
KCI USA, INC.2019-05-06
SNAP™
KCI USA, INC.2018-10-04
SNAP™
KCI USA, INC.2018-10-04
V.A.C.® SIMPLACE™
KCI USA, INC.2018-09-28
V.A.C.® SIMPLACE™
KCI USA, INC.2018-09-28
SNAP™
KCI USA, INC.2018-09-24
SNAP™
KCI USA, INC.2018-09-24
SNAP™
KCI USA, INC.2018-09-24
SNAP™
KCI USA, INC.2018-09-24
SNAP™
KCI USA, INC.2018-09-24
SNAP™
KCI USA, INC.2018-09-18
SNAP™
KCI USA, INC.2018-09-18
SNAP™
KCI USA, INC.2018-09-18
SNAP™
KCI USA, INC.2018-09-18
PREVENA PLUS™
KCI USA, INC.2018-09-10
PREVENA PLUS DUO™ PEEL & PLACE™
KCI USA, INC.2018-09-10

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