Product code MQU— Ophthalmic

FDA has cleared 4 devices under product code MQU between 1997 and 2000, filed by 3 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.

• 20001 clearance
• 19982 clearances
• 19971 clearance

• Integrated Orbital Implants, Inc.2 clearances
• Porex Technologies Corp.1 clearance
• Fci Ophthalmics, Inc.1 clearance

• K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEIntegrated Orbital Implants, Inc.·2000-04-10
• K980822 — TITANIUM PEG SYSTEMFci Ophthalmics, Inc.·1998-07-09
• K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMIntegrated Orbital Implants, Inc.·1998-02-04
• K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIESPorex Technologies Corp.·1997-06-30