Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation 882.4310
2510(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) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. IMRI CRANI-A ATTACHMENT
Product Usage:
Pneumatic system Terminated |
HBE | K040186 |
| Oct 6, 2016 | The Anspach Effort, Inc. IMRI MOTOR
Product Usage:
Pneumatic system Terminated |
HBE | K040186 |
| Oct 6, 2016 | The Anspach Effort, Inc. IMRI AIR CONTROL
Product Usage:
Pneumatic system Terminated |
HBE | K040186 |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 19, 2016 | Stryker Instruments Div. of Stryker Corporation 2.3MM Tapered Router,
Product Number 5407-FA2-023
A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat
(ENT)/Otology /Neurotology/ Otorhinola Terminated |
HBE | K143399 |
| Jul 14, 2016 | Stryker Instruments Div. of Stryker Corporation 6.0mm Round Fluted Bur, Super Long Terminated |
HBE | K143320 |
| Jul 14, 2016 | Stryker Instruments Div. of Stryker Corporation 5.0mm Round Fluted Bur, Super Long Terminated |
HBE | K143320 |
| Jun 28, 2016 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dis Terminated |
HBE | K081475 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM;
REF S-8N-L-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure;
REF S-5D-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -4MM Carbide Fluted Ball, Extends 27MM;
REF S-4BL-C-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Fluted Ball, Extends 27MM;
REF M-5B-27-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 4MM Fluted Ball, Extends 27MM;
REF M-4B-27-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 8MM x 12.5MM Fluted Barrel;
REF M-8BA-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 7MM Extra Coarse Diamond Ball;
REF M-7DX-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 7MM Fluted Acorn;
REF M-7AC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 6MM x 11.3MM Fluted Barrel;
REF M-6BA-A-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM x 11.3MM Fluted Barrel;
REF M-5BA-A-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM
REF L-9DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Ball; 9MM
REF L-9B-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Extra Coarse Diamond Ball; 8MM
REF L-8DX-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only;
REF L-8DRC-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Barrel; 8MM x 12.5MM
REF L-8BA-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Barrel; 8MM x 12.5MM
REF L-8BA-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM
REF L-7DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Acorn, 7MM
REF L-7AC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM
REF L-6DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM ,
REF L-5DRC-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | K113476 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 5820-10-240;
EXP (repackager), Stryker (OEM)
Drills, burrs, trephines & a Terminated |
HBE | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 5820-10-160;
EXP (repackager), Stryker (OEM)
Drills, burrs, trephines & ac Terminated |
HBE | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 5820-10-130;
EXP (repackager), Stryker (OEM)
Drills, burrs, trephines Terminated |
HBE | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 5820-10-120;
EXP (repackager), Stryker (OEM)
Drills, burrs, trephines & a Terminated |
HBE | None listed |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBE | K002903 |
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