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Found 89 results
510(k) Data Aggregation
K Number
K171879Device Name
HylaGuard Moisturizing Cream
Manufacturer
Founders Science Group, LLC
Date Cleared
2017-10-16
(115 days)
Product Code
MGQ, FRO
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HylaGuard Moisturizing Cream is intended for the dressing and management of minor skin irritations and minor burns, including sunburn.
Device Description
HylaGuard Moisturizing Cream is a non-sterile, off-white, low odor, fragrance free, topical device product. HylaGuard Moisturizing Cream forms a semi-permeable, physical barrier that moisturizes and protects skin. HylaGuard Moisturizing Cream is an over-the-counter (OTC) device. The same device has been cleared for prescription use in K150914 under the name of Dash-Topic Plus Cream.
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K Number
K083024Device Name
HYLATOPIC EMOLLIENT FOAM
Manufacturer
COLLEGIUM PHARMACEUTICAL INCORPORATED
Date Cleared
2009-03-27
(169 days)
Product Code
MGQ, HYL
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosolbased emollient foam. is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Hylatopic TM Emollient Foam is indicated for use in:
- · Atopic Dermatitis
- Allergic Contact Dermatitis
- Radiation Dermatitis .
Device Description
Hylatopic™ Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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K Number
K041342Device Name
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
Manufacturer
STIEFEL LABORATORIES, INC.
Date Cleared
2005-07-19
(425 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
MimyX Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor burns, including sunburn.
Device Description
MimyX™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requires a physician diagnosis of disease state) and Over-the-Counter (OTC) use.
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K Number
K041268Device Name
SILVERSITE OR CALGITROL
Manufacturer
ADRI
Date Cleared
2004-09-20
(131 days)
Product Code
MGQ, FRO
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Professional Indications (Prescription Use):
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites
Device Description
The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.
The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.
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K Number
K040019Device Name
SILVERSEAL
Manufacturer
NOBLE FIBER TECHNOLOGIES
Date Cleared
2004-07-23
(199 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
Device Description
X-Static® SILVERSEAL™ Hydrogel Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.
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K Number
K040517Device Name
TENDERWET ACTIVE
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2004-03-25
(27 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.
Device Description
Not Found
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K Number
K022587Device Name
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
Manufacturer
MEDTRADE PRODUCTS LTD.
Date Cleared
2003-08-22
(382 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These dressings are intended for OTC use on wounds such as:
- Minor cuts and grazes .
- Minor scalds and burns .
- Insect bites .
MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:
- . Third degree burns
Device Description
MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.
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K Number
K024367Device Name
SINCLAIR WOUND AND SKIN EMULSION
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2003-07-28
(209 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns, including sunburn.
Device Description
Sinclair Wound and Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over-thecounter (OTC) use.
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K Number
K024054Device Name
XYLOS XCELL ANTIMICROBIAL DRESSING
Manufacturer
XYLOS CORPORATION
Date Cleared
2003-03-07
(88 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XCell® Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.
The device is intended for one-time use.
Device Description
Not Found
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K Number
K022584Device Name
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
Manufacturer
CARDIOTECH INTL.
Date Cleared
2002-12-30
(147 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Product Code :
MGQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full- thickness wounds. They may be used on the following wounds: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites
Device Description
CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive, and absorptive. The wound contact surface is composed of an antibiotic containing hydrogel. The OTC antibiotic mixture used consists of the following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. A second outer layer consists of a polymeric film.
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