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Holder, Head, Neurosurgical (Skull Clamp)

FDA product code HBL · Class 2 · Neurology

740
Registered devices
5,826
Adverse events
14
Recalls
50
510(k) clearances

Devices with this code

MAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONDORO COBRA™ Flexible Rotary Arm — Black Forest Medical GmbHCoil Fixation Plate LUCY — Noras MRI products GmbHDORO® Interface Skull Clamp — Black Forest Medical GmbHTray with accessories for fixation of MF-table adapter and skull clamp — medical bees GmbHDORO® Reusable Skull Pins — Black Forest Medical GmbHDORO COBRA® Flexibler Arm — Black Forest Medical GmbHClearPoint — Clearpoint Neuro, Inc.MAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONDORO LUCENT® iMRI Transfer Collision Indicator — Black Forest Medical GmbHDORO® Horseshoe Pad — Black Forest Medical GmbHMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMultipurpose Head Frame — MIZUHO CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONDORO® Transitional Member — Black Forest Medical GmbHMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONDORO LUCENT® iMRI Transfer Collision Indicator — Black Forest Medical GmbHMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATION

Recent recalls

DateFirmReason
2025-12-08IMRIS Imaging IncTorque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, r
2025-03-14Pro-Med Instruments GmbhPotential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation syste
2022-02-17Deerfield Imaging, Inc.Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally
2020-11-11Integra LifeSciences Corp.Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
2019-06-26Deerfield Imaging, Inc.Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in
2018-07-05Pro-Med Instruments GmbhThe combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to
2018-07-05Pro-Med Instruments GmbhThe combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to
2018-07-05Pro-Med Instruments GmbhThe combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to
2017-11-02Pro-Med Instruments GmbhThe firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end
2017-08-14Deerfield Imagingincorrect thread on thumbscrews

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.