Home › Device types › HBL
Holder, Head, Neurosurgical (Skull Clamp)
FDA product code HBL · Class 2 · Neurology
740
Registered devices
5,856
Adverse events
14
Recalls
50
510(k) clearances
Devices with this code
MAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONAll-Purpose Arch — Noras MRI products GmbHDORO® Head Support — Black Forest Medical GmbHDORO® Headrest System Radiolucent — Black Forest Medical GmbHDORO® Swivel Horseshoe — Black Forest Medical GmbHMultipurpose Head Frame — MIZUHO CORPORATIONDORO® CereTom® — Black Forest Medical GmbHMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONRadiolucent Head Frame — MIZUHO CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONHand Rest R — MIZUHO CORPORATIONOP Kopfhalter LUCY Upgrade Set Philips — Noras MRI products GmbHDORO COBRA™ Flexible Rotary Arm — Black Forest Medical GmbHDORO® Halo — Black Forest Medical GmbHMAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONOR Head Holder LUCY with HeadCoilSet Philips 1.5T — Noras MRI products GmbHMF- Key of the table adapter — medical bees GmbHDORO® Transitional Member RDL — Black Forest Medical GmbHPhantom Holder LUCY — Noras MRI products GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-08 | IMRIS Imaging Inc | Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, r |
| 2025-03-14 | Pro-Med Instruments Gmbh | Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation syste |
| 2022-02-17 | Deerfield 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 |
| 2020-11-11 | Integra LifeSciences Corp. | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram |
| 2019-06-26 | Deerfield 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 |
| 2018-07-05 | Pro-Med Instruments Gmbh | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to |
| 2018-07-05 | Pro-Med Instruments Gmbh | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to |
| 2018-07-05 | Pro-Med Instruments Gmbh | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to |
| 2017-11-02 | Pro-Med Instruments Gmbh | The 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 |
| 2017-08-14 | Deerfield Imaging | incorrect thread on thumbscrews |
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