Medical Device Manufacturer · US , Atlanta , GA

Retinalabs.Com

5 submissions · 5 cleared · Since 2000
5
Total
5
Cleared
0
Denied

Retinalabs.Com — FDA 510(k) Submissions

Retinalabs.Com has submitted 5 FDA 510(k) premarket notifications since 2000, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Endoilluminator, Calculator, Drug Dose, Pump, Infusion, Ophthalmic, Cannula, Ophthalmic, Device, Irrigation, Ocular Surgery . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
K003036 · KYG Device, Irrigation,... · Ophthalmic
Dec 2000 84d
PDT DOSECALCULATOR, MODEL 80000
K000418 · NDC Calculator, Drug Dose · General Hospital
Oct 2000 259d
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
K000457 · HMX Cannula, Ophthalmic · Ophthalmic
May 2000 88d
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
K000416 · MPA Endoilluminator · Ophthalmic
May 2000 90d
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
K000420 · MRH Pump, Infusion, Ophthalmic · Ophthalmic
May 2000 90d
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All5 Ophthalmic 4 General Hospital 1