10 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·November 5, 2024
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code OMP·November 11, 2016
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code OMP·November 11, 2016
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code OMP·July 21, 2016
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
FDA Recall
Open, Classified
·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
FDA Recall
Open, Classified
·Smith & Nephew Medical, Ltd.·Product code OMP·March 11, 2024
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
FDA Recall
Open, Classified
·Smith & Nephew Medical, Ltd.·Product code OMP·March 11, 2024
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·January 17, 2025
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HMP·November 15, 2023