Product code MYU— Neurology

FDA has cleared 6 devices under product code MYU between 1999 and 2003, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20034 clearances
• 20001 clearance
• 19991 clearance

• Parallax Medical, Inc.3 clearances
• Vista Scientific, LLC1 clearance
• Cardinalhealth1 clearance
• Bryan Corp.1 clearance

• K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAParallax Medical, Inc.·2003-12-12
• K032388 — BONE CEMENT RADIO-OPACIFIERCardinalhealth·2003-10-31
• K024359 — VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1Vista Scientific, LLC·2003-08-08
• K023445 — TRACERS BONE CEMENT OPACIFIERParallax Medical, Inc.·2003-03-11
• K002063 — BIOTRACE, MODEL 1730Bryan Corp.·2000-08-10
• K991893 — PARALLAX TRACER RADIOPAQUE PARTICLESParallax Medical, Inc.·1999-08-13