510(k) K070078 ยท FYA Gown, Surgical
STRYKER T4 HYTREL TOGA
| Applicant | Stryker Instruments, Instruments Div., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Feb 2, 2007 |
| Received | Jan 9, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, Large; Catalog Number: 0400-760-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga (S/M); Catalog Number: 0400-810-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga, Regular; Catalog number: 0400-830-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga, X-Large; Catalog number: 0400-850-000
Sterile personal protection garment Terminated |
FYA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100
Sterile personal protection garment Terminated |
FYA | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room Terminated |
FYA | None listed |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room p Terminated |
FYA | None listed |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-850-000 T4 Toga, Zipper,
(XL-Tall) Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room Terminated |
FYA | None listed |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating ro Terminated |
FYA | None listed |
| Jun 6, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 0400-850-100 T5 zipper Toga
with Peel Away, Sterile, EO; single use;
Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.