Company ยท US
Kci USA, Inc. (Kinetic Concepts, Inc.)
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2017. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 13 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 26, 2017 | K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Oct 4, 2016 | K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Jun 20, 2016 | K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Aug 20, 2015 | K141017 | PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Mar 24, 2014 | K133232 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Jan 15, 2013 | K123878 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Oct 11, 2012 | K121883 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Oct 5, 2012 | K120499 | ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Mar 14, 2011 | K103156 | V.A.C. VERAFLO CLEANSE DRESSING SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Dec 15, 2010 | K102956 | V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Sep 17, 2010 | K100657 | V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Mar 10, 2010 | K093526 | V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Oct 4, 2006 | K062227 | V.A.C. THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||