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Panels › Neurology › Product code HBE · Class 2

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)
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Top companies in HBE

Company510(k)sRecalls
The Anspach Effort, Inc.7104
Stryker Instruments Div. of Stryker Corporation094
Surgify Medical OY419
Stryker714
Stryker Instruments Division of Stryker Corporation013
Aesculap, Inc.50
EXP Pharmaceutical Services Corp04
Medtronic Xomed, Inc.22
Aesculap Implant Systems LLC03
Biomet Microfixation21
DateFirm and productCodeLinked 510(k)
Jan 15, 2014The Anspach Effort, Inc.
MCA7-2SB - 2MM Fluted 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-1SD - 1MM 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-1SB - 1MM Fluted 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-15SD - 1.5MM 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-15SB - 1.5MM Fluted 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-08SD - 0.8MM 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-07SD - 0.7MM 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-06SD - 0.6MM 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA7-05SD - 0.5MM 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		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Terminated		 HBEK042783
Jan 15, 2014The Anspach Effort, Inc.
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic proced
Terminated		 HBEK042783
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, inclu
Terminated		 HBEK080802
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Terminated		 HBEK080802
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball p
Terminated		 HBEK080802
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8
Terminated		 HBEK080802
Jan 10, 2014The Anspach Effort, Inc.
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Terminated		 HBEK042783
Jan 9, 2014The Anspach Effort, Inc.
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIA
Terminated		 HBEK042783
Nov 13, 2013The Anspach Effort, Inc.
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, al
Terminated		 HBEK080802
May 24, 2013The Anspach Effort, Inc.
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Terminated		 HBEK113476
Oct 18, 2012The Anspach Effort, Inc.
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Terminated		 HBEK011444
K080802
Oct 18, 2012The Anspach Effort, Inc.
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Terminated		 HBEK011444
K080802
Oct 18, 2012The Anspach Effort, Inc.
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Terminated		 HBEK011444
K080802
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-08SD, QTY: 1***0.8 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, In
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, In
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-06SD, QTY: 1***0.6 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, In
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-05SD, QTY: 1***0.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, In
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-2SD, QTY: 1***2 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc.
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-1SD, QTY: 1***1 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc.
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-2SB, QTY: 1***2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-1SB, QTY: 1***1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
***REF MCA5-15SD, QTY: 1***1.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, In
Terminated		 HBENone listed
Aug 1, 2011The Anspach Effort, Inc.
"***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort, Inc. 4500 Riverside D
Terminated		 HBEK042783
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303
Feb 14, 2011Stryker 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		 HBEK032303

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