Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation 882.4310
1510(k)s in 12 months (65 all time)
19recalls in 12 months (258 all time)
203recalls that name a 510(k)
Top companies in HBE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K040076 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***MA Attachment, Straight version Custom***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K040076 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K040076 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0001***eMax Hand Control***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K080802 |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Barrel Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, n Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm x 3.8mm Precision Neuro Drill
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surger Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm x 3.8mm Neuro Drill
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surger Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 1.5mm Wire Pass Drill
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as e Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 1.3mm Wire Pass Drill
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as e Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Lindemann Drill Short, 1.6mm
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ea Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm Acorn Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, no Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Acorn Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, no Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Barrel Bur
Sterile Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm Egg Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Egg Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 2.0mm Zyphr Elite Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm Zyphr Elite Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Zyphr Elite Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.5mm Zyphr Elite Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 2.0mm Tapered Round Elite Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as w Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm Round Fluted Bur Aggressive
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.5mm Round Fluted Bur Aggressive
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0mm Round Fluted Bur Aggressive
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 4.5mm Round Fluted Bur Aggressive
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm Round Fluted Bur Aggressive
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 5.5mm Round Fluted Bur Soft Touch
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 3.0mm Round Fluted Bur Soft Touch
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 6.0mm Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as e Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 4.0mm Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as e Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 2.0mm Round Fluted Bur
Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 1.0mm Round Fluted Bur
Sterile
Product Usage:
The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as Terminated |
HBE | None listed |
| Jun 11, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker 0.5mm Round Fluted Bur Sterile
Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | K042783 |
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