510(k) K960248 ยท FMF Syringe, Piston
GENERAL PROCEDURE KIT
| Applicant | Physician Industries, Inc., North Salt Lake UT, US |
| Decision | Substantially Equivalent, Apr 12, 1996 |
| Received | Jan 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Bone Marrow Biopsy Trays Catalogue No. 3404253
Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable p Terminated |
FMF | None listed |
| Jun 22, 2011 | Integra LifeSciences Corp. Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119. Terminated |
FMF | None listed |
| Jun 22, 2011 | Integra LifeSciences Corp. Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119. Terminated |
FMF | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other produc Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06, Integra LifeSciencesCorporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pro Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other products s Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other p Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pro Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and othe Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Block Tray, Disposable, Convenience Kit, Reorder Number CUS835, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other products supplied Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pro Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other product Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), Disposable, Convenience Kit, Reorder Number PITRW2035, Integra LifeSciences Corporation, Salt Lake City, Utah Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pro Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pr Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other p Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other products s Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other product Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other products Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder Number PICH2235, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, s Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes an Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and othe Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other products s Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pr Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other produc Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other produc Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and othe Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pr Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other pr Terminated |
CAZ | None listed |
| Sep 21, 2009 | Integra Life Sciences Corporation Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.
Kits contain syringes, drugs, sponges, drapes and other Terminated |
CAZ | None listed |
| Aug 14, 2008 | Integra Pain Management Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791 Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.