Panels › General, Plastic Surgery › Product code FYA · Class 2
Gown, Surgical
Regulation 878.4040
10510(k)s in 12 months (298 all time)
5recalls in 12 months (129 all time)
106recalls that name a 510(k)
Top companies in FYA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2004 | K040485 | MAXAIR SURGICAL HELMET SYSTEM Bio-Medical Devices, Inc. | FYA |
| Apr 27, 2004 | K040764 | STRYKER T4 HYTREL ZIPPER TOGA Stryker Corp. | FYA |
| Feb 5, 2004 | K032631 | INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) Lac Mac, Ltd. | FYA |
| Nov 20, 2003 | K033057 | DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE Deroyal | FYA |
| Oct 15, 2003 | K031408 | DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) Deroyal | FYA |
| Sep 16, 2003 | K031933 | MEDLINE REUSABLE SURGICAL GOWNS (100X) Medline Industries, Inc. | FYA |
| May 6, 2003 | K030536 | LAC-MAC LIMITED INNERBLOC O.R. GOWN Lac Mac, Ltd. | FYA |
| Apr 28, 2003 | K030364 | DEROYAL GOWNS, STERILE, NON-STERILE Deroyal Industries, Inc. | FYA |
| Jan 14, 2003 | K021992 | DHS DISPOSABLE HOOD SYSTEM Biomet, Inc. | FYA |
| Nov 18, 2002 | K023635 | SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN Sri/Surgical Express, Inc. | FYA |
| Nov 8, 2002 | K023266 | PRIMAGARD SURGICAL GOWNS Primeline Medical Products, Inc. | FYA |
| Oct 2, 2002 | K023167 | BREATHABLE SURGICAL GOWN Allegiance Healthcare Corp. | FYA |
| Aug 1, 2002 | K022162 | STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA Stryker Instruments | FYA |
| May 22, 2002 | K013846 | ULTRAGARD IMPERVIOUS REINFORCED GOWN Precept Medical Products, Inc. | FYA |
| Mar 18, 2002 | K020593 | CONVERTORS SMS POLYOLEFIN GOWN Allegiance Healthcare Corp. | FYA |
| Dec 7, 2001 | K012186 | MASTER & FRANK SURGICAL GOWNS (STERILE) Master & Frank Ent. Co., Ltd. | FYA |
| Dec 3, 2001 | K012268 | TRIMAX Standard Textile Co., Inc. | FYA |
| Oct 15, 2001 | K012240 | MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE Mercan AB | FYA |
| Sep 24, 2001 | K012984 | BREATHABLE IMPERVIOUS GOWNS Allegiance Healthcare Corp. | FYA |
| Jun 7, 2001 | K010799 | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) Standard Textile Co., Inc. | FYA |
| Feb 16, 2001 | K003755 | MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES Medline Industries, Inc. | FYA |
| Oct 26, 2000 | K003194 | STACKHOUSE LENS HOOD, MODEL SA-700/FS Stackhouse, Inc. | FYA |
| Aug 17, 2000 | K000605 | STACKHOUSE LENS HOOD, MODEL SA-700/F Stackhouse, Inc. | FYA |
| Jul 11, 2000 | K000902 | KLINIDRAPE REINFORCED SURGICAL GOWNS Molnlycke Health Care, Inc. | FYA |
| Jul 5, 2000 | K000901 | KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION Molnlycke Health Care, Inc. | FYA |
| Apr 21, 2000 | K001189 | MODIFICATION TO CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Mar 2, 2000 | K993170 | MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS Medline Industries, Inc. | FYA |
| Feb 18, 2000 | K994244 | CONVERTORS SURGICAL GOWNS, STERILE Allegiance Healthcare Corp. | FYA |
| Feb 18, 2000 | K992445 | MED-GUARD SURGEON'S GOWN Kappler USA | FYA |
| Jan 20, 2000 | K992436 | GOWN BACK, MODEL 13-403N; 13-404N; 13-405N Techstyles | FYA |
| Dec 20, 1999 | K994053 | STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE Stryker Instruments | FYA |
| Oct 15, 1999 | K993148 | STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA Stryker Instruments | FYA |
| Sep 22, 1999 | K992951 | CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Aug 12, 1999 | K992514 | CONVERTORS BREATHABLE SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Apr 16, 1999 | K991034 | CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Apr 13, 1999 | K990395 | BARRIER SURGICAL GOWNS Johnson & Johnson Medical, Div. of Ethicon, Inc. | FYA |
| Apr 2, 1999 | K984422 | STERILE BACK SURGICAL GOWN WITH HAND TOWEL Medical Sterilization, Inc. | FYA |
| Jan 14, 1999 | K982058 | ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN Encompass Group, LLC | FYA |
| Dec 14, 1998 | K982694 | MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES Medline Industries, Inc. | FYA |
| Nov 30, 1998 | K982059 | ROTECNO 2000 SURGICAL GOWN Encompass Group, LLC | FYA |
| Oct 28, 1998 | K982693 | MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS Medline Industries, Inc. | FYA |
| Jul 10, 1998 | K981393 | MICROCOOL SURGICAL GOWN Kimberly-Clark Corp. | FYA |
| May 15, 1998 | K981073 | MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK Medcom Laundry Service, Inc. | FYA |
| Dec 4, 1997 | K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) Customed, Inc. | FYA |
| Oct 21, 1997 | K972832 | PROVISION SURGICAL HELMET SYSTEM Depuy, Inc. | FYA |
| Oct 20, 1997 | K970893 | ULTRASOUND TRANSDUCER DRAPE Protek Medical Products, Inc. | FYA |
| Feb 27, 1997 | K962666 | BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN Bemiss-Jason Corp., Triad Medical Div. | FYA |
| Jan 30, 1997 | K954674 | P1OP2B OR P1O92T Kay Borch A/S | FYA |
| Nov 20, 1996 | K963809 | COOL-ZONE Kappler USA | FYA |
| Oct 28, 1996 | K961341 | CONVERTORS POLYOLEFIN FABRIC GOWNS Baxter Healthcare Corp | FYA |
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