ClearanceBrief
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)
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Top companies in FRO

DateFirm and productCodeLinked 510(k)
Jul 7, 2026ConvaTec, Inc
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Open, Classified
FROK152926
Jun 1, 2026Oculus Technologies of Mexico, S.A. de C.V.
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Open, Classified
FROK172851
Feb 20, 2026Medline 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
FROK112666
Feb 20, 2026Medline 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
FROK112666
Feb 13, 2026Integra 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
FROK150985
Feb 13, 2026Integra 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
FROK053095
Feb 13, 2026Integra 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
FROK101793
Sep 3, 2025Integra 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
FRONone listed
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK080315
Sep 3, 2025Integra 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
FROK080315
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Open, Classified
FRONone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Water, USP, 100mL, REF RDI30295
Open, Classified
FROK173276
Feb 12, 2025Integra 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
FROK101793
Oct 10, 2024Integra 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
FROK080315
Oct 9, 20243M Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Open, Classified
FROK063458
K080620 +4
Dec 20, 2023Nurse 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
FRONone listed
Dec 20, 2023Nurse 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
FROK083042
Jun 21, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Open, Classified
FROK131796
Dec 19, 2022ConvaTec, Inc
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Open, Classified
FROK123481
Sep 26, 2022Mckesson 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
FRONone listed
Sep 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
Open, Classified
FROK162508
Sep 26, 2022Mckesson 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
FROK090453
K183645
Sep 26, 2022Mckesson 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
FROK090453
Sep 26, 2022Mckesson 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
FRONone listed
Sep 26, 2022Mckesson 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
FROK101793
K921290
Sep 26, 2022Mckesson 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
FRONone listed
Sep 26, 2022Mckesson 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
FROK060804
Mar 21, 2022Acera Surgical Inc
Restrata, Part Number RWM1-2X2
Terminated
FROK170300
K193583
Mar 16, 2022CellEra LLC
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Terminated
FRONone listed
Mar 16, 2022CellEra LLC
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Terminated
FRONone listed
Mar 16, 2022CellEra LLC
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Terminated
FRONone listed
Mar 16, 2022CellEra LLC
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Terminated
FRONone listed
Mar 16, 2022CellEra LLC
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Terminated
FRONone listed
Sep 22, 2021Z-Medica, LLC
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Terminated
FROK072474
Mar 26, 2020Gentell, 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
FRONone listed
Mar 26, 2020Gentell, 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
FRONone listed
Mar 26, 2020Gentell, 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
FRONone listed
Mar 26, 2020Gentell, 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
FRONone listed
Mar 5, 2020Gentell, 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
FRONone listed
Mar 5, 2020Gentell, 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
FRONone listed
Mar 5, 2020Gentell, 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
FRONone listed
Mar 5, 2020Gentell, 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
FRONone listed
Dec 13, 2019Southwest Technologies Inc
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Terminated
FROK872165
May 10, 2018Anika 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
FROK073251
Apr 25, 2018Conseal 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
FRONone listed

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