MYU · Class II · 21 CFR 882.5300

FDA Product Code MYU: Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Leading manufacturers include Parallax Medical, Inc., Bryan Corp. and Vista Scientific, LLC.

6
Total
6
Cleared
105d
Avg days
1999
Since

FDA 510(k) Cleared Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty Devices (Product Code MYU)

6 devices
1–6 of 6
Cleared Dec 12, 2003
TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
K033230
Parallax Medical, Inc.
Neurology · 67d
Cleared Oct 31, 2003
BONE CEMENT RADIO-OPACIFIER
K032388
Cardinalhealth
Neurology · 88d
Cleared Aug 08, 2003
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
K024359
Vista Scientific, LLC
Neurology · 221d
Cleared Mar 11, 2003
TRACERS BONE CEMENT OPACIFIER
K023445
Parallax Medical, Inc.
Neurology · 147d
Cleared Aug 10, 2000
BIOTRACE, MODEL 1730
K002063
Bryan Corp.
Neurology · 34d
Cleared Aug 13, 1999
PARALLAX TRACER RADIOPAQUE PARTICLES
K991893
Parallax Medical, Inc.
Neurology · 71d

About Product Code MYU - Regulatory Context