HRGClass I
Engine, Trephine, Accessories, Ac-powered
Ophthalmic · 21 CFR 886.4070
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances6All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury1
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
6 clearances for this product code
- Bkg Opthalmics USA, Inc.Dec 14, 2001
K013151 · ASMOTOM AUTOMATED TREPHINE SYSTEM
- Laser Center Dev. Corp.Jun 23, 1998
K981063 · AUTOMATED CORNEAL TREPHINE
- Optical Systems Intl., Inc.Jul 31, 1985
K843957 · ULTRATHIN/SP LENS
- Scanlan Intl., Inc.Jun 5, 1984
K841515 · SCANLAN VASCU-STATT II
- Edward Weck, Inc.Jan 17, 1983
K823901 · TREPHINE BLADES-VARIOUS MODELS
- Intl. Ophthalmic Industries Corp.Nov 5, 1979
K791763 · (MICRO-KERATRON, MICRO DUCT TREPHINE)