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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-820-100 T5 Zipper Toga
with Peel Away, Sterile, O; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating r Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3
Cut, Sterile, O; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room per Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-820-000S3 T4 Toga w/Inside
Shoulder Ties, Sterile, O; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operatin Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-820-000 T4 Zipper Toga
(L/XL) Sterile, O; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room perso Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-810-000 T4 Zipper Toga
(S/M) Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room perso Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating ro Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-720-000S5 T5 Pullover Toga
w/Peel Away, Sterile, EO; single use.
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room pe Terminated |
FYA | K070078 |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-710-000
T4 Pullover Toga (S/M)
Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room per Terminated |
FYA | K070078 |
| Nov 7, 2012 | Kimberly-Clark Corporation MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile
The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer Terminated |
FYA | K103406 |
| Jul 16, 2012 | Kimberly-Clark Corporation MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras.
The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to Terminated |
FYA | K091357 |
| Jul 16, 2012 | Kimberly-Clark Corporation MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras.
The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn Terminated |
FYA | K091357 |
| Jun 14, 2012 | Stryker Instruments Div. of Stryker Corporation T4-Hytrel Zipper Toga
Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/o Terminated |
FYA | K944393 |
| Jun 14, 2012 | Stryker Instruments Div. of Stryker Corporation T5 Hytrel Zipper Toga.
Product Usage:
The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/o Terminated |
FYA | K944393 |
| Jan 18, 2011 | Kimberly-Clark Corporation Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras. Terminated |
FYA | None listed |
| Jan 18, 2011 | Kimberly-Clark Corporation Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras. Terminated |
FYA | None listed |
| Dec 28, 2007 | Precept Medical Products, Inc. Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box, 6 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Me Terminated |
FYA | None listed |
| Dec 28, 2007 | Precept Medical Products, Inc. Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Me Terminated |
FYA | None listed |
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Disposable Hood; product 5431-50-000 Terminated |
FYA | K972832 |
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Barrier Universal Hood/Gown; product 5431-33-000 Terminated |
FYA | None listed |
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Hytrel Universal Hood/Gown; product 5431-31-000 Terminated |
FYA | K972832 |
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Hytrel Elastomer Hood; product 5431-05-000. Terminated |
FYA | K972832 |
| Jan 14, 2003 | Sterile Surgical Systems Llc Sterilized gowns and towels.
MULTI-GOWN PACK: MAJOR - contains 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' re- Terminated |
FYA | None listed |
| Jan 14, 2003 | Sterile Surgical Systems Llc Sterilized gowns and towels.
MULTI-GOWN PACK: MINOR - contains - 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' r Terminated |
FYA | None listed |
| Jan 14, 2003 | Sterile Surgical Systems Llc Sterilized gowns and towels.
C-Section Pack - contains 8 towels, 1 each large single-ply scrub nurse gown/towel, 2 each large gortex surgeons gown/towel, 2 each 36'' re-usable wrappers, 1 24'' re-usa Terminated |
FYA | None listed |
| Jan 14, 2003 | Sterile Surgical Systems Llc Sterilized gowns and towels.
LINEN PACK II - contains 12 towels, 1 each large gortex scrub nurse gown/towel, 1 each extra large surgeons gown/towel, 2 36'' re-usable wrappers, 1 24'' re-usable wrappe Terminated |
FYA | None listed |
| Jan 14, 2003 | Sterile Surgical Systems Llc Sterile gowns and towels in packages.
LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse gown/towel, 1 each large single-ply surgeons gown, 2 36'' re-usable wrappers, 1 24'' re-us Terminated |
FYA | None listed |
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