FDA 510(k) Applications for Medical Device Product Code "MRH"
(Pump, Infusion, Ophthalmic)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K993039 |
BAUSCH & LOMB, INC. |
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) |
01/07/2000 |
K963434 |
ESCALON TREK MEDICAL |
VISCOUS FLUID SYSTEM |
11/25/1996 |
K212797 |
Glaukos |
iPrime Viscodelivery System |
01/06/2022 |
K050716 |
ISCIENCE SURGICAL CORPORATION |
ISCIENCE SURGICAL VISCOINJECTOR |
04/21/2005 |
K971067 |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
DIGI-INJECTOR |
09/19/1997 |
K213173 |
MicroSurgical Technologies Inc |
TrabEx Pro |
06/08/2022 |
K211680 |
New World Medical, Inc. |
Streamline Surgical System |
10/08/2021 |
K981907 |
PEREGRINE SURGICAL LTD. |
V.F.I.-VISCOUS FLUID INFUSION TUBING SET |
08/04/1998 |
K000420 |
RETINALABS.COM |
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 |
05/08/2000 |
K974253 |
SCIERAN TECHNOLOGIES, INC. |
CPD COMMANDER |
02/25/1998 |
K232214 |
Sight Sciences Inc., |
OMNI Surgical System |
08/25/2023 |
K201953 |
Sight Sciences, Inc. |
OMNI PLUS Surgical System |
08/11/2020 |
K173332 |
Sight Sciences, Inc. |
OMNI Surgical System |
12/21/2017 |
K202678 |
Sight Sciences, Inc. |
OMNI Surgical System |
03/01/2021 |
K171905 |
Sight Sciences, Inc. |
VISCO 360 Viscosurgical System |
07/27/2017 |
K143205 |
Sight Sciences, Inc. |
Viscoelastic Injector |
12/05/2014 |
K132494 |
SIGHT SCIENCES, INC. |
VISCOELASTIC INJECTOR |
10/22/2013 |
K972664 |
STORZ INSTRUMENT CO. |
STORZ MILLENNIUM VISCOUS FLUID SYSTEM |
10/10/1997 |
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