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 |
|---|---|---|---|
| Jul 30, 2009 | K083870 | EXSALT SD7 WOUND DRESSING Exciton Technologies, Inc., CA | FRO |
| Jul 30, 2009 | K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING Southwest Technologies, Inc. | FRO |
| Jul 22, 2009 | K083113 | ACTICOAT FLEX 7 DRESSING Smith & Nephew, Inc. | FRO |
| Jun 17, 2009 | K082910 | CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES Aso, LLC | FRO |
| Jun 2, 2009 | K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER Oculus Innovative Sciences, Inc. | FRO |
| May 20, 2009 | K090725 | OCULUS MICROCYN WOUND GEL Oculus Innovative Sciences, Inc. | FRO |
| May 11, 2009 | K090092 | SOCKIT! AND MCMERLIN DERMAL WOUND GEL Mcmerlin Dental Products LP | FRO |
| Apr 16, 2009 | K083659 | SILVER WOUND PAD Milliken & Co. | FRO |
| Apr 8, 2009 | K083007 | PROWICK Arthrex, Inc. | FRO |
| Apr 2, 2009 | K090585 | NEOSALUS CREAM Quinnova Pharmaceuticals | FRO |
| Apr 2, 2009 | K082333 | ASAP WOUND DRESSING GEL American Biotech Labs | FRO |
| Mar 17, 2009 | K090141 | PRONTOSAN ANTIMICROBIAL WOUND GEL B.Braun Medical, Inc. | FRO |
| Feb 26, 2009 | K090453 | SILVER ALGINATE 11 WOUND DRESSING Advanced Medical Solutions Limited, GB | FRO |
| Feb 26, 2009 | K083103 | ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B Acrymed, Inc. | FRO |
| Feb 26, 2009 | K082296 | COPA AMD Covidien Lp, Formerly Registered AS Tyco Healthcar | FRO |
| Feb 11, 2009 | K080949 | KERATEC WOUND DRESSINGS Keratec Limited | FRO |
| Jan 13, 2009 | K082089 | PRUMYX CREAM Prugen, Inc. | FRO |
| Dec 29, 2008 | K083355 | WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 Blairex Laboratories, Inc. | FRO |
| Dec 18, 2008 | K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE Nurse Assist, Inc. | FRO |
| Dec 1, 2008 | K081977 | PROSIT WOUND TREATMENT DEVICE Silverleaf Medical Products, Inc. | FRO |
| Nov 12, 2008 | K080503 | SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING Advanced Medical Solutions Limited, GB | FRO |
| Oct 9, 2008 | K082330 | PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION Primary Care Solutions, Inc. | FRO |
| Sep 24, 2008 | K081363 | NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING Advanced Medical Solutions Limited, GB | FRO |
| Sep 16, 2008 | K073019 | SILVERMED ANTIMICROBIAL SILVER HYDROGEL Argentis Biomedical Incorporated | FRO |
| Sep 12, 2008 | K070309 | NEOSALUS Quinnova Pharmaceuticals | FRO |
| Aug 28, 2008 | K073197 | SILVER ANTIMICROBIAL WOUND GEL Advanced Medical Solutions Limited, GB | FRO |
| Jun 27, 2008 | K080497 | DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) Derma Sciences Canada, Inc., CA | FRO |
| Jun 19, 2008 | K081584 | DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY Derma Sciences, Inc. | FRO |
| Jun 19, 2008 | K072876 | PRONTOSAN WOUND IRRIGATION SOLUTION B.Braun Medical, Inc. | FRO |
| May 28, 2008 | K081274 | SURESKIN SILVER BANDAGES Euromed, Inc. | FRO |
| May 28, 2008 | K073213 | THERABOND ANTIMICROBIAL BARRIER SYSTEMS Choice Therapeutics | FRO |
| May 19, 2008 | K080620 | MODIFICATION TO 3M TEGADERM CHG DRESSING 3M Company-3M Health Care | FRO |
| May 7, 2008 | K070463 | REVERA WOUND CARE, MODEL MDW0060 Revalesio Corporation | FRO |
| May 2, 2008 | K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING Convatec, A Division of E.R. Squibb & Sons, LLC | FRO |
| May 1, 2008 | K071442 | SUPRASORB A +AG Specialty Fibres and Materials, Ltd., GB | FRO |
| Apr 25, 2008 | K071552 | PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING Medline Industries, Inc. | FRO |
| Apr 23, 2008 | K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY Derma Sciences, Inc. | FRO |
| Apr 23, 2008 | K073610 | ELTA ADVANCED WOUND WASH Swiss American Products, Inc. | FRO |
| Apr 23, 2008 | K073547 | ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL Anacapa Technologies, Inc. | FRO |
| Apr 4, 2008 | K071483 | TETRIX CREAM Coria Laboratories, Ltd. | FRO |
| Mar 5, 2008 | K080471 | RADIO BIOAQUACARE Bioartificial Gel Technologies (Bagtech), Inc. | FRO |
| Feb 8, 2008 | K071557 | COLLAWOUND HYDROGEL Collamatrix Co., Inc., TW | FRO |
| Dec 21, 2007 | K072068 | BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS Bioartificial Gel Technologies (Bagtech), Inc. | FRO |
| Nov 19, 2007 | K071371 | COPA AMD ANTIMICROBIAL WOUND DRESSING Tyco Healthcare Group LP | FRO |
| Nov 9, 2007 | K072378 | PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 Arthrex, Inc. | FRO |
| Nov 7, 2007 | K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY Derma Sciences, Inc. | FRO |
| Sep 28, 2007 | K071056 | NEUTROPHASE WOUND CLEANSER Novabay Pharmaceuticals | FRO |
| Sep 14, 2007 | K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 Tyco Healthcare | FRO |
| Sep 12, 2007 | K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 Tyco Healthcare | FRO |
| Aug 22, 2007 | K071703 | ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC Swiss American Products, Inc. | FRO |
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