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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2013 | K122634 | IODOFOAM IODOPHOR FOAM DRESSING Progressive Wound Care Technologies, LLC | FRO |
| Feb 28, 2013 | K123679 | 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 3M Company | FRO |
| Feb 14, 2013 | K123072 | VASHE WOUND THERAPY SOLUTION Puricore, Inc. | FRO |
| Feb 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM Huizhou Foryou Medical Devices Co., Ltd. | FRO |
| Jan 24, 2013 | K123071 | VASHE SKIN AND WOUND HYDROGEL Puricore, Inc. | FRO |
| Dec 11, 2012 | K123113 | L.A.M. IMP WOUND GEL Glycobiosciences, Inc., CA | FRO |
| Dec 11, 2012 | K113693 | NIXALL TM WOUND AND SKIN CARE Seriously Clean, Ltd. | FRO |
| Nov 30, 2012 | K121559 | HYLATOPICPLUS LOTION Precision Dermatology Incorporated | FRO |
| Nov 30, 2012 | K121361 | CURALINE POLYURETHANE FOAM AWC DRESSING Curaline, Inc. | FRO |
| Oct 26, 2012 | K120930 | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING Medtrade Products , Ltd., GB | FRO |
| Sep 24, 2012 | K113836 | BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) Avery Dennison Belgie Bvba | FRO |
| Sep 6, 2012 | K120730 | LOUTREX TOPICAL CREAM Acella Pharmaceuticals, LLC | FRO |
| Aug 28, 2012 | K122297 | ENLUXTRA HUMIFIBER WOUND DRESSING Basf Venture Capital America, Inc. | FRO |
| Aug 13, 2012 | K121819 | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER Covalontechnologies, Inc., CA | FRO |
| Aug 8, 2012 | K113820 | NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER Novabay Pharmaceuticals | FRO |
| Jul 25, 2012 | K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER Convatec, Inc. | FRO |
| Jul 25, 2012 | K121134 | TL TRISEB CREAM Trigen Laboratories, Inc. | FRO |
| Jun 27, 2012 | K121522 | POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) Polyremedy, Inc. | FRO |
| May 31, 2012 | K111382 | CELVER Cellulose Concepts, LLC | FRO |
| May 23, 2012 | K121227 | MANUKA FILL Links Medical Products, Inc. | FRO |
| May 23, 2012 | K120976 | MANUKA IG Links Medical Products, Inc. | FRO |
| May 4, 2012 | K112549 | IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER Covalontechnologies, Inc., CA | FRO |
| Apr 20, 2012 | K112666 | SALINE WOUND WASH Nanoplas, Inc. | FRO |
| Apr 12, 2012 | K113583 | CURAD ANTIBACTERIAL BANDAGE Medline Industries, Inc. | FRO |
| Apr 5, 2012 | K120828 | BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES Coloplast A/S | FRO |
| Mar 7, 2012 | K113807 | DEXERYL CREAM Pierre Fabre Medical Devices | FRO |
| Feb 9, 2012 | K113774 | HPR PLUS EMOLLIENT FOAM Prugen IP Holdings, Inc. | FRO |
| Feb 9, 2012 | K113772 | HPR EMOLLIENT FOAM Prugen IP Holdings, Inc. | FRO |
| Dec 15, 2011 | K113564 | EXSALT T7 WOUND DRESSING Exciton Technologies, Inc., CA | FRO |
| Dec 13, 2011 | K111168 | PRECISION SKIN EMULSION Precision Dermatology Incorporated | FRO |
| Dec 7, 2011 | K110457 | 3M TEGADERM MATRIX DRESSING 3M Company | FRO |
| Nov 18, 2011 | K110762 | AVO BARRIER TOPICAL EMULSION Trigen Laboratories, Inc. | FRO |
| Sep 23, 2011 | K111578 | CORELEADER COLLA-ALGI FIBER MODEL CAW Coreleader Biotech Co., Ltd., TW | FRO |
| Sep 1, 2011 | K110062 | MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG Medipurpose Pte. , Ltd. | FRO |
| Aug 19, 2011 | K110757 | TL-CERMIDE SKIN BARRIER EMULSION Trigen Laboratories, Inc. | FRO |
| Aug 19, 2011 | K110172 | SONAFINE WOUND DRESSING Stratus Pharmaceutical | FRO |
| Jul 27, 2011 | K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY Derma Sciences, Inc. | FRO |
| Jul 26, 2011 | K101114 | ADVANCIS ACTIVON TUBE Advancis Medical, GB | FRO |
| Jun 22, 2011 | K102942 | CORELEADER ALGIPLASTER MODEL AP 050501 Coreleader Biotech Co., Ltd., TW | FRO |
| Jun 16, 2011 | K103713 | ELTA WOUND CLEANSER Swiss American Products, Inc. | FRO |
| Jun 3, 2011 | K110732 | EMULSION SB Prugen IP Holdings, Inc. | FRO |
| May 20, 2011 | K103067 | EXSALT SD7 WOUND DRESSING Exciton Technologies, Inc., CA | FRO |
| May 2, 2011 | K103793 | DURAFIBER AG Smith & Nephew, Inc. | FRO |
| Apr 12, 2011 | K102943 | CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 Coreleader Biotech Co., Ltd., TW | FRO |
| Apr 6, 2011 | K110744 | PRONTOSAN WOUND IRRIGATION SOLUTION B.Braun Medical, Inc. | FRO |
| Apr 1, 2011 | K110727 | HYLATOPICPLUS CREAM Precision Dermatology Incorporated | FRO |
| Mar 30, 2011 | K103106 | CHLORASHIELD TM ANTIMICROBIAL DRESSING Care Fusion 213, LLC | FRO |
| Mar 24, 2011 | K110042 | MANUKATEX Manuka Medical Limited | FRO |
| Mar 14, 2011 | K110458 | SILVER ANTIMICROBIAL WOUND GEL Advanced Medical Solutions Limited, GB | FRO |
| Feb 22, 2011 | K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY Derma Sciences, Inc. | FRO |
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