Product code FRO ยท Class U
Dressing, Wound, Drug
20510(k)s in 12 months (708 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 |
|---|---|---|---|
| Apr 17, 2000 | K991818 | ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 Acrymed, Inc. | FRO |
| Apr 5, 2000 | K000051 | ACTICOAT FOAM DRESSING Westaim Biomedical, Inc. | FRO |
| Dec 30, 1999 | K993969 | SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION Winchester Laboratories, LLC | FRO |
| Nov 5, 1999 | K992817 | ANTIBACTERIAL ADHESIVE BANDAGE William Feinstein & Associates, Inc. | FRO |
| Sep 24, 1999 | K984210 | SILVERLON WOUND PACKING STRIPS Argentum International, LLC | FRO |
| Sep 17, 1999 | K990810 | ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING Maersk Medical, Ltd. | FRO |
| Aug 12, 1999 | K992363 | SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN Euromed, Inc. | FRO |
| Jun 29, 1999 | K991287 | SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA Advanced Medical Solutions Group Plc, GB | FRO |
| May 27, 1999 | K990891 | DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING Dermaphylyx, Inc. | FRO |
| Apr 14, 1999 | K990332 | DUMEX IODOFORM PACKING STRIP Dumex Medical Surgical Products, Ltd., CA | FRO |
| Mar 19, 1999 | K990042 | SILON DUAL-DRESS Bio Med Sciences, Inc. | FRO |
| Mar 1, 1999 | K984599 | MODIFICATION OF CUTINOVA FOAM DRESSING Beiersdorf-Jobt, Inc. | FRO |
| Mar 1, 1999 | K984597 | MODIFICATION OF CUTINOVA CAVITY DRESSING Beiersdorf-Jobt, Inc. | FRO |
| Mar 1, 1999 | K984595 | MODIFICATION OF CUTINOVA HYDRO DRESSING Beiersdorf-Jobt, Inc. | FRO |
| Mar 1, 1999 | K984593 | MODIFICATION OF CUTINOVA THIN DRESSING Beiersdorf-Jobt, Inc. | FRO |
| Feb 22, 1999 | K984208 | SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD Argentum International, LLC | FRO |
| Jan 28, 1999 | K982493 | COMPEED PSORIASIS DRESSING Coloplast Corp. | FRO |
| Dec 16, 1998 | K983173 | BIATAIN FOAM ADHESIVE DRESSING Coloplast Corp. | FRO |
| Dec 16, 1998 | K983163 | BIATAIN FOAM DRESSING Coloplast Corp. | FRO |
| Nov 25, 1998 | K983249 | SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN Euromed, Inc. | FRO |
| Sep 25, 1998 | K981299 | SILVERLON CONTACT WOUND DRESSING Argentum International, LLC | FRO |
| May 4, 1998 | K980777 | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING Dumex Medical Surgical Products, Ltd., CA | FRO |
| Mar 5, 1998 | K972185 | 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE Steripak, Ltd., GB | FRO |
| Feb 13, 1998 | K974348 | ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING Laboratoires Urgo S.A. | FRO |
| Dec 23, 1997 | K973807 | DUODERM HYDROACTIVE PASTE Convatec, A Bristol-Myers Squibb Co. | FRO |
| Dec 23, 1997 | K973689 | DUODERM HYDROACTIVE DRESSING Convatec, Ltd. | FRO |
| Dec 23, 1997 | K973688 | DUODERM CONTROL GEL FORMULA BORDER DRESSING Convatec, Ltd. | FRO |
| Dec 22, 1997 | K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING Convatec, A Division of E.R. Squibb & Sons | FRO |
| Dec 17, 1997 | K973717 | COMBIDERM ACD Convatec, A Bristol-Myers Squibb Co. | FRO |
| Dec 17, 1997 | K973716 | DUODERM EXTRA THIN CGF DRESSING Convatec, A Bristol-Myers Squibb Co. | FRO |
| Dec 16, 1997 | K973511 | KENDALL CURITY PETROLATUM GAUZE Kendall Healthcare Products Co. Div.Of Tyco Health | FRO |
| Dec 15, 1997 | K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) Kendall Healthcare Products Co. Div.Of Tyco Health | FRO |
| Dec 1, 1997 | K973855 | IT HYDROCOLLOID WITH ZINC Innovative Technologies , Ltd., GB | FRO |
| Jul 29, 1997 | K970566 | ARGLAES FILM DRESSING Maersk Medical, Ltd., GB | FRO |
| Jun 24, 1997 | K971126 | HYDROCOLLOID WOUND DRESSINGS Innovative Technologies , Ltd., GB | FRO |
| Feb 7, 1997 | K964701 | MITRAFLEX PIGMENTED WOUND DRESSING Polymedica Industries, Inc. | FRO |
| Sep 23, 1996 | K963039 | SURESKIN STANDARD, BORDER, AND THIN Euromed A/S | FRO |
| Sep 20, 1996 | K962590 | SIGNALDRESS Convatec, A Division of E.R. Squibb & Sons | FRO |
| Nov 29, 1995 | K954243 | TECNOL SALINE WET DRESSING Tecnol Medical Products, Inc. | FRO |
| Nov 2, 1995 | K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC Derma Sciences, Inc. | FRO |
| Nov 2, 1995 | K954742 | DERMAGRAN WET DRESSING (ZINC-SALINE) Derma Sciences, Inc. | FRO |
| Nov 2, 1995 | K954740 | DERMAGRAN WOUND DRESSING Derma Sciences, Inc. | FRO |
| Nov 2, 1995 | K954739 | DERMAGRAN HYDROPHILIC OINTMENT Derma Sciences, Inc. | FRO |
| Oct 23, 1995 | K954621 | RECLOSABLE WOUND COVER Hollister, Inc. | FRO |
| Oct 6, 1995 | K954235 | HOLLISTER HYDROCOLLOID WOUND DRESSING Hollister, Inc. | FRO |
| Aug 16, 1995 | K952948 | SALINE DRESSING Busse Hospital Disposables, Inc. | FRO |
| Aug 7, 1995 | K952907 | EX-111 WOUND DRESSING Variseal Manufacturing Corp. | FRO |
| Jul 11, 1995 | K950933 | HOLLISTER HYDROCOLLOID WOUND DRESSINGS Hollister, Inc. | FRO |
| Jun 8, 1995 | K952007 | ADHEROL SEPP APPLICATOR Medi-Flex Hospital Products, Inc. | FRO |
| Mar 1, 1995 | K950132 | DUMEX WET DRESSINGS Dumex Medical Surgical Products, Ltd., CA | FRO |
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