HQTClass IIImplant
Shell, Scleral
Ophthalmic · 21 CFR 886.3800
MDR events2All time
Recalls0All time
Registered firms11Currently listed
510(k) clearances4All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
M/s Tarun Enterprises
Prayagraj, Uttar Pradesh, IN
Soper Brothers & Associates
HOUSTON, TX, US
Midwest Eye Laboratories Woodbury Llc
Saint Paul, MN, US
Akriti Ophthalmic Private Limited
Hyderabad Telangana, IN
Dallas Eye Prosthetics
Dallas, TX, US
Midwest Eye Laboratories, Inc.
Eau Claire, WI, US
Accutome, Inc.
Malvern, PA, US
Speedway
India Delhi, IN
Midwest Eye Laboratories Sioux Falls Llc
SIOUX FALLS, SD, US
Lights' Prosthetic Eyes, Inc.
Peoria, IL, US
Midwest Eye Laboratories, Inc.
ROCHESTER, MN, US
510(k) clearances
4 clearances for this product code