FRO
WATER JEL STERILE GEL-SOAKED BURN DRESSING
- Advisory panel
- Unknown
- Total cleared
- 701
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FRO
1–100 of 701- K254191 — IWD-Gel
- K252023 — MiraChlor Antimicrobial Wound Solution
- K251999 — Promogran Prisma Collagen Matrix with ORC and Silver
- K252028 — LUOFUCON® Antimicrobial Wound Gel
- K251582 — Redermax Antibacterial Wound Matrix
- K252568 — New Day Skin Spray
- K250890 — SBC1 Cream
- K252759 — revyve® Antimicrobial Skin and Wound Cleanser
- K251757 — Puracyn® Plus Antimicrobial Irrigation Solution
- K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
- K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
- K250115 — Hemastyl() Wound Dressing
- K251866 — Tegaderm Post-Op Transparent Antimicrobial Dressing
- K243166 — Dermalage
- K243415 — Granudacyn® Wound Irrigation Solution
- K251093 — Bonvadis®
- K243457 — Nixall Antimicrobial Solutions Skin & Wound Hydrogel
- K243875 — Spectricept Skin and Wound Cleanser
- K242406 — SiOxC Cream
- K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP
- K240809 — LUOFUCON® Silver Collagen Dressing
- K242758 — Atrauman® Ag
- K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
- K240510 — Microdacyn Hydrogel
- K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
- K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
- K211943 — Microlyte Ag/Lidocaine
- K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
- K240722 — Derma-R Cream (Derma-R Cream)
- K233399 — Microdacyn Wound Care Solution
- K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
- K241225 — Silverlon® Wound Contact, Burn Contact Dressing
- K241809 — coactiv+ Antimicrobial Wound Gel
- K212521 — Field Shield Wound Dressing
- K240552 — Irrisept Antimicrobial Wound Lavage
- K232080 — Puracyn® Plus Antimicrobial Irrigation Solution
- K232333 — Anti-bacterial bandage
- K233111 — ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
- K232655 — Bonvadis®
- K223360 — LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
- K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
- K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
- K231088 — Copper Foam Dressing (Prescription and OTC)
- K221110 — LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
- K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
- K231057 — Antibacterial Gel Wound Dressing
- K230190 — Polyver Silver Alginate Dressing (Prescription and OTC)
- K231564 — Skin and Wound Cleanser
- K213473 — Antimicrobial Gelling Fiber Dressing with PHMB
- K222143 — APIS (R), VERIS (TM)
- K222025 — G4Derm / G4Derm Plus Synthetic Wound Matrix
- K221570 — Antibacterial bandage
- K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
- K221311 — Antibacterial Bandage
- K223259 — coactiv+ Antimicrobial Wound Gel
- K223310 — Antimicrobial Silicone PHMB Foam Wound Dressing
- K223377 — BIASURGE Advanced Surgical Solution
- K220673 — Sterile Silver Alginate Wound Dressing
- K221532 — PHMB Wound Dressing
- K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
- K213514 — Spectricept Skin and Wound Cleanser
- K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
- K220286 — ELECTROCYN soma
- K221720 — Extra Silver Gelling Fiber Dressing
- K221218 — Silverlon Wound Contact, Burn Contact Dressings
- K222657 — MEBO Wound Dressing
- K212554 — Bonvadis Topical Cream
- K211123 — LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
- K210718 — LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
- K210135 — PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
- K210466 — Silver Gelling Fiber Dressing
- K202982 — Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
- K203446 — TorrentX Wound Wash
- K211972 — Omeza Collagen Matrix
- K210974 — High Performance Antimicrobial Gelling Fiber with Silver
- K203835 — MIS Solution
- K201138 — AMSure® Single Use Saline Topical Solution
- K201324 — Antibacterial Bandage
- K201016 — LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
- K200821 — anti-bacterial bandage
- K200767 — SilverStream Gel
- K193439 — MEBO Wound Dressing
- K200835 — 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
- K200641 — HaloGUARD Protective Disc with CHG
- K192478 — LT Antibacterial Alginate with Silver Dressing
- K191819 — Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
- K192463 — PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
- K193085 — PuraDERM Gel
- K190129 — AC5 Topical Gel
- K191536 — Biatain Silicone Ag
- K192527 — Rochal Antimicrobial Wound Gel
- K190730 — IODOSORB
- K190756 — IODOFLEX
- K190268 — Hydrofera Blue READY - Border
- K190342 — BIAFINE Topical Cream
- K183681 — Protego Antimicrobial Wound Dressing
- K181428 — Clyra Wound Irrigation Solution
- K181478 — Roosin Xeroform Petrolatum Dressing
- K183662 — Saline Wound Wash, SteriCleanse(TM)
- K183208 — Suprasorb A + Ag R
Data sourced from openFDA. This site is unofficial and independent of the FDA.