Company
Stryker Instruments Division of Stryker Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
43recalls (0 in 12 months)
41recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY
For Functional Endoscop Terminated |
GFA | None listed |
| Jul 6, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210.
This device is intended f Terminated |
MDM | None listed |
| Mar 28, 2011 | Stryker Instruments Division of Stryker Corporation Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI.
The DeKompressor Percutaneous Discectomy Probe is intended for use in t Terminated |
HRX | K032473 |
| Mar 28, 2011 | Stryker Instruments Division of Stryker Corporation Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI.
The DeKompressor Percutaneous Discectomy Probe is intended for use in th Terminated |
HRX | K032473 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include com Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fe Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle f Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fea Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle featu Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle f Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fea Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fe Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle featu Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the product series of the Stryker Navigation System. The system comprises software fo Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-652-000. It is part of the product series of the Stryker Navigation System. The system comprises software Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number 6000-651-300. It is part of the product series of the Stryker Navigation System. The system comprises software Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651-200. It is part of the product series of the Stryker Navigation System. The system comprises software for pr Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-op Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative su Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software Terminated |
HAW | K062640 |
| Feb 25, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000.
It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative su Terminated |
HAW | K062640 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone a Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Feb 14, 2011 | Stryker Instruments Division of Stryker Corporation Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.
These burs are intended for use during various surgical procedures to cut hard tissue or bone Terminated |
HBE | K032303 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |
| Jan 25, 2011 | Stryker Instruments Division of Stryker Corporation The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suc Terminated |
FQH | K972069 |