28 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·May 13, 2020
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·May 13, 2020
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·April 8, 2020
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·April 8, 2020
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·April 8, 2020
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·April 8, 2020
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·May 13, 2020
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions
FDA Enforcement
Class II
·Ongoing·Gentell, Inc·May 13, 2020
Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 26, 2018
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 26, 2018
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 8, 2015
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 8, 2015
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·March 25, 2015
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·March 25, 2015