Product code FRO ยท Class U
Dressing, Wound, Drug
19510(k)s in 12 months (707 all time)
7recalls in 12 months (82 all time)
56recalls that name a 510(k)
Top companies in FRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2026 | ConvaTec, Inc Aquacel Ag Surgical SP
REF: 413556
9cm x 15cm/3.5 in. x 6 in., Sterile R Open, Classified |
FRO | K152926 |
| Jun 1, 2026 | Oculus Technologies of Mexico, S.A. de C.V. PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 Open, Classified |
FRO | K172851 |
| Feb 20, 2026 | Medline Industries, LP Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7 Open, Classified |
FRO | K112666 |
| Feb 20, 2026 | Medline Industries, LP Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7 Open, Classified |
FRO | K112666 |
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) Private Label CVS. Model Number: CVS405406.
Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & Open, Classified |
FRO | K150985 |
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045.
MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autoly Open, Classified |
FRO | K053095 |
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815.
MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healin Open, Classified |
FRO | K101793 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: CVS Honey Pad
Product Name: CVS Honey Pad
Model/Catalog Number: 9370613, 937404
Product Description: Infused with natural medical-grade honey
Manuka (Leptospermum) honey is a medical-grad Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney HCS Surgical Adhesive Sheet
Model/Catalog Number: 31738
Product Description: MEDIHONEY HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Hydrogel Adhesive Sheet
Model/Catalog Number: 31722, 31744
Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist w Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Hydrogel
Model/Catalog Number: 31620, 31640
Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound d Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Adhesive Hydrogel Sheet Dressing
Model/Catalog Number: 31720, 31740
Product Description: MEDIHONEY Adhesive Hydrogel Sheet Dressing with
Leptospermum Hone Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney HCS Sheet Dressing with Leptospermum
Model/Catalog Number: 31612, 31622, 31644
Product Description: MEDIHONEY HCS SHEET DRESSING with LEPTOSPERMUM HONEY i Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Tube
Model/Catalog Number: 31515 and 31535
Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active L Open, Classified |
FRO | K080315 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Paste
Model/Catalog Number: 31505
Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermu Open, Classified |
FRO | K080315 |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 Open, Classified |
FRO | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Sterile Water, USP, 100mL, REF RDI30295 Open, Classified |
FRO | K173276 |
| Feb 12, 2025 | Integra LifeSciences Corp. Brand Name: MediHoney Gel
Product Name: MediHoney Wound & Burn Dressing Gel
Model/Catalog Number: 31815
Software Version: N/A
Product Description: MediHoney Gel with Active Leptospermum Honey is a moi Open, Classified |
FRO | K101793 |
| Oct 10, 2024 | Integra LifeSciences Corp. MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) Open, Classified |
FRO | K080315 |
| Oct 9, 2024 | 3M Company - Health Care Business 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R Open, Classified |
FRO | K063458 K080620 +4 |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007 Open, Classified |
FRO | None listed |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water/Saline: Brand Name: Product Name/Product Code:
CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/ Open, Classified |
FRO | K083042 |
| Jun 21, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel Open, Classified |
FRO | K131796 |
| Dec 19, 2022 | ConvaTec, Inc ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive Open, Classified |
FRO | K123481 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145 Open, Classified |
FRO | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158 Open, Classified |
FRO | K162508 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400.
b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.7 Open, Classified |
FRO | K090453 K183645 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563.
b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) C Open, Classified |
FRO | K090453 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453.
b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454 Open, Classified |
FRO | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS Open, Classified |
FRO | K101793 K921290 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104.
b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #6875151010 Open, Classified |
FRO | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Mod Open, Classified |
FRO | K060804 |
| Mar 21, 2022 | Acera Surgical Inc Restrata, Part Number RWM1-2X2 Terminated |
FRO | K170300 K193583 |
| Mar 16, 2022 | CellEra LLC 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Terminated |
FRO | None listed |
| Mar 16, 2022 | CellEra LLC 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Terminated |
FRO | None listed |
| Mar 16, 2022 | CellEra LLC 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Terminated |
FRO | None listed |
| Mar 16, 2022 | CellEra LLC 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Terminated |
FRO | None listed |
| Mar 16, 2022 | CellEra LLC 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Terminated |
FRO | None listed |
| Sep 22, 2021 | Z-Medica, LLC QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding
Model / Part# 200 Terminated |
FRO | K072474 |
| Mar 26, 2020 | Gentell, Inc 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 Open, Classified |
FRO | None listed |
| Mar 26, 2020 | Gentell, Inc 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 o Open, Classified |
FRO | None listed |
| Mar 26, 2020 | Gentell, Inc 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 o Open, Classified |
FRO | None listed |
| Mar 26, 2020 | Gentell, Inc 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 Open, Classified |
FRO | None listed |
| Mar 5, 2020 | Gentell, Inc 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 thickne Open, Classified |
FRO | None listed |
| Mar 5, 2020 | Gentell, Inc 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, inclu Open, Classified |
FRO | None listed |
| Mar 5, 2020 | Gentell, Inc 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, inclu Open, Classified |
FRO | None listed |
| Mar 5, 2020 | Gentell, Inc 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, includ Open, Classified |
FRO | None listed |
| Dec 13, 2019 | Southwest Technologies Inc Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic Terminated |
FRO | K872165 |
| May 10, 2018 | Anika Therapeutics, Inc. Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301
Product Usage:
Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. Terminated |
FRO | K073251 |
| Apr 25, 2018 | Conseal International, Inc. Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04
The product is a topical spray used to treat discomfort and other path Terminated |
FRO | None listed |
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