Home › Device types › GXL
Screwdriver, Skullplate
FDA product code GXL · Class 1 · Neurology
70
Registered devices
16
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
OPERACE — PB SWISS TOOLS AGOPERACE — PB SWISS TOOLS AGNeuro & Craniofacial Fixation System — INNO Holdings, Inc.KLS E-Coupling Adapter — PRO-DEX, INC.OPERACE — PB SWISS TOOLS AGOPERACE — PB SWISS TOOLS AGSurgical Instrument — Jeil Medical CorporationKLS Martin Surgical Driver, Non-Torque Limiting — PRO-DEX, INC.Surgical Instrument — Jeil Medical CorporationPlusDrive — Synthes GmbHOPERACE — PB SWISS TOOLS AGMatrixPRO driver Handpiece — PRO-DEX, INC.PlusDrive — Synthes GmbHPro-Dex Surgical Driver Medicon — PRO-DEX, INC.Neuro & Craniofacial Fixation System — INNO Holdings, Inc.OPERACE — PB SWISS TOOLS AGMatrixPRO Driver Battery Pack, Sterile — PRO-DEX, INC.Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER) — PRO-DEX, INC.Pro-Dex Surgical Driver AO Collet — PRO-DEX, INC.MatrixPRO Driver Loaner — PRO-DEX, INC.NA — Synthes GmbHOPERACE — PB SWISS TOOLS AGAtlas Pro Driver — PRO-DEX, INC.OPERACE — PB SWISS TOOLS AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-01-30 | Synthes, Inc. | The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the |
| 2006-03-08 | Medtronic Neurosurgery | Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along th |
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