FDA Device Registration & Listing · San Antonio, TX, US · Registration 3009897021
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-11-14 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2024-06-24 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2023-03-24 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2022-07-18 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2023-03-24 |
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | General, Plastic Surgery | Class 2 | 878.4683 | 2019-11-14 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2022-07-06 |
| QFC | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | General, Plastic Surgery | Class 2 | 878.4783 | 2022-07-06 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2021-10-19 |
| QFC | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | General, Plastic Surgery | Class 2 | 878.4783 | 2023-02-16 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2019-10-31 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004943440 | 3M Purification, S. de R.L. de C. V. | San Luis Potosi Mexico, MX |
| 3003775292 | KCI POLYMEDICS BV | PEER Limburg, BE |
| 3036108847 | Solventum US LLC | Eden Prairie, MN, US |
| 3038988287 | Solventum Canada Limited | Morden Manitoba, CA |
| 3032763783 | Solventum Poland Manufacturing SP. ZO.O | Wroclaw Dolnoslaskie, PL |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K113032 | Spiracur, Inc. | SNAP WOUND CARE SYSTEM | 2011-12-01 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2013 | Accuro Medical Product LLC | 2 | Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181
Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds. |
| Z-0039-2015 | Smith & Nephew, Inc. | 2 | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier
Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). |
| Z-0040-2015 | Smith & Nephew, Inc. | 2 | RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier
Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). |
| Z-0041-2015 | Smith & Nephew, Inc. | 2 | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier
Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3015143781 | VIRTUAL TRUTRENDS TEK.BIL.ILT.SIS.SAN.DAN.EGT.VE TIC.LTD.STI. | ankara, TR |
| 2029275 | Sterigenics U.S., LLC | Corona, CA, US |
| 3002807523 | MEDELA AG | BAAR Zug, CH |
| 3030145672 | CADENT TECHNOLOGIES, INC. | Temecula, CA, US |
| 3002807314 | Synergy Health Ireland Ltd | Tullamore Offaly, IE |
3009897021 when referencing this establishment in official correspondence.