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 |
|---|---|---|---|
| Jun 4, 2015 | K143590 | Alevicyn SG Antipruritic Gel Oculus Innovative Sciences | FRO |
| Jun 3, 2015 | K141637 | SPB SKIN EMULSION Biotd S.A. | FRO |
| Jun 1, 2015 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) Roosin Medical Devices Co., Ltd., CN | FRO |
| May 14, 2015 | K141863 | PURICORE WOUND HYDROGEL SPRAY DRESSING Puricore, Inc. | FRO |
| May 8, 2015 | K140905 | DERMAFINE Invado Pharmaceuticals | FRO |
| Apr 30, 2015 | K150256 | SILVERLON BURN CONTACT DRESSINGS Argentum Medical | FRO |
| Apr 20, 2015 | K143527 | IPM Wound Gel Bio, IPM Derm Gel Bio Glycobiosciences, Inc., CA | FRO |
| Apr 6, 2015 | K141619 | LUOFUCON SILVER FOAM DRESSING Huizhou Foryou Medical Devices Co., Ltd. | FRO |
| Mar 23, 2015 | K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Feb 13, 2015 | K143058 | PuraDerm Gel 3-D Matrix, Inc. | FRO |
| Feb 13, 2015 | K142775 | Neuwater TM (HydrocynTM aqua) Vigilenz Medical Devices, MY | FRO |
| Feb 10, 2015 | K141382 | BIOS KING BIOCELLULOSE FILM Coreleader Biotech Co., Ltd., TW | FRO |
| Jan 26, 2015 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) Bsn Medical GmbH, DE | FRO |
| Jan 23, 2015 | K133729 | WOUND DRESSING WITH MANUKA HONEY Manuka Health New Zealand , Ltd. | FRO |
| Nov 7, 2014 | K143001 | SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING Argentum Medical | FRO |
| Nov 7, 2014 | K140389 | CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 Entrotech Life Sciences, Inc. | FRO |
| Oct 31, 2014 | K141660 | NAWALUTION SKIN AND WOUND CLEANSER Nawa Heilmittel GmbH | FRO |
| Oct 22, 2014 | K141603 | Ultra Silver Dressings Milliken Healthcare Products, LLC | FRO |
| Aug 28, 2014 | K141573 | SILVERLON ISLAND WOUND DRESSING Argentum Medical | FRO |
| Aug 21, 2014 | K132326 | IONSIL GEL Virchow Biotech Pvt, Ltd. | FRO |
| Aug 8, 2014 | K141012 | HYDROCLEANSE WOUND CARE SOLUTION Oculus Innovative Sciences | FRO |
| Jun 19, 2014 | K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER The Hymed Group Corp. | FRO |
| May 20, 2014 | K140483 | ASAP OTC WOUND DRESSING GEL Abl Medical, LLC | FRO |
| May 12, 2014 | K131176 | ROSS RU SKIN DISCONTINUITIES Biotd S.A. | FRO |
| May 2, 2014 | K133934 | MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) Links Medical Products, Inc. | FRO |
| May 1, 2014 | K122817 | SILVERLON ISLAND WOUND DRESSING Argentum Medical, LLC | FRO |
| Apr 28, 2014 | K133542 | PURACYN PLUS SKIN AND WOUND Innovacyn, Inc. | FRO |
| Apr 22, 2014 | K140147 | BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE Bio-Medical Carbon Technology Co., Ltd. | FRO |
| Mar 31, 2014 | K131848 | VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) Puricore, Inc. | FRO |
| Mar 26, 2014 | K133775 | EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING Exciton Technologies, Inc., CA | FRO |
| Mar 14, 2014 | K131796 | MANUKA FILL WOUND DRESSING Links Medical Products, Inc. | FRO |
| Mar 13, 2014 | K133764 | CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL Avery Dennison Belgie Bvba, BE | FRO |
| Mar 3, 2014 | K123193 | IPM WOUND GEL BIO Glycobiosciences, Inc., CA | FRO |
| Feb 14, 2014 | K130781 | L.A.M. IPM WOUND GEL, IPM DERM GEL Glycobiosciences, Inc., CA | FRO |
| Feb 12, 2014 | K130040 | MEPITEL AG Molnlycke Health Care | FRO |
| Jan 2, 2014 | K130670 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING Hydrofera, LLC | FRO |
| Dec 20, 2013 | K132329 | NIVATOPIC PLUS Nivagen Pharmaceuticals, Inc. | FRO |
| Dec 16, 2013 | K123678 | HYALMIX CREAM Igi Laboratories, Inc. | FRO |
| Oct 29, 2013 | K123910 | WOUNDWASH SALINE SPRAY Neilmed Pharmaceuticals, Inc. | FRO |
| Oct 8, 2013 | K130857 | PRONTOSAN WOUND GEL X B.Braun Medical, Inc. | FRO |
| Aug 28, 2013 | K123724 | DERMISEB CREAM Igi Laboratories, Inc. | FRO |
| Aug 7, 2013 | K123904 | PROTHELIAL Mueller Medical International, LLC | FRO |
| Jul 24, 2013 | K131542 | NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC Novabay Pharmaceuticals, Inc. | FRO |
| Jul 3, 2013 | K130553 | ABSOCLEAR Pharmaplast S.A.E. | FRO |
| Jul 2, 2013 | K130350 | PROCELLERA Vomaris Innovations, Inc. | FRO |
| Jun 6, 2013 | K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE Convatec, Inc. | FRO |
| Jun 6, 2013 | K123394 | CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING Coreleader Biotech Co., Ltd., TW | FRO |
| May 1, 2013 | K122595 | HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM Dermal Life, LLC | FRO |
| Apr 5, 2013 | K123892 | MEPILEX TRANSFER AG Molnlycke Health Care | FRO |
| Mar 18, 2013 | K123219 | URGOCLEAN ABSORBENT WOUND DRESSING Laboratoires Urgo, FR | FRO |
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