Panels › General Hospital › Product code MRH · Class 2
Pump, Infusion, Ophthalmic
Regulation 880.5725
1510(k)s in 12 months (20 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MRH
| Company | 510(k)s | Recalls |
|---|---|---|
| Sight Sciences, Inc. | 8 | 0 |
| New World Medical, Inc. | 2 | 0 |
| Bausch & Lomb, Inc. | 1 | 0 |
| Escalon Trek Medical | 1 | 0 |
| Glaukos | 1 | 0 |
| Iscience Surgical Corporation | 1 | 0 |
| Medical Instrument Development Laboratories, Inc. | 1 | 0 |
| Microsurgical Technologies, Inc. | 1 | 0 |
| Peregrine Surgical , Ltd. | 1 | 0 |
| Retinalabs.Com | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2026 | K253760 | OMNI Ultra Surgical System (1-110) Sight Sciences, Inc. | MRH |
| Feb 14, 2025 | K243503 | VIA360 Surgical System New World Medical, Inc. | MRH |
| Aug 25, 2023 | K232214 | OMNI Surgical System Sight Sciences, Inc. | MRH |
| Jun 8, 2022 | K213173 | TrabEx Pro Microsurgical Technologies, Inc. | MRH |
| Jan 6, 2022 | K212797 | iPrime Viscodelivery System Glaukos | MRH |
| Oct 8, 2021 | K211680 | Streamline Surgical System New World Medical, Inc. | MRH |
| Mar 1, 2021 | K202678 | OMNI Surgical System Sight Sciences, Inc. | MRH |
| Aug 11, 2020 | K201953 | OMNI PLUS Surgical System Sight Sciences, Inc. | MRH |
| Dec 21, 2017 | K173332 | OMNI Surgical System Sight Sciences, Inc. | MRH |
| Jul 27, 2017 | K171905 | VISCO 360 Viscosurgical System Sight Sciences, Inc. | MRH |
| Dec 5, 2014 | K143205 | Viscoelastic Injector Sight Sciences, Inc. | MRH |
| Oct 22, 2013 | K132494 | VISCOELASTIC INJECTOR Sight Sciences, Inc. | MRH |
| Apr 21, 2005 | K050716 | ISCIENCE SURGICAL VISCOINJECTOR Iscience Surgical Corporation | MRH |
| May 8, 2000 | K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 Retinalabs.Com | MRH |
| Jan 7, 2000 | K993039 | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) Bausch & Lomb, Inc. | MRH |
| Aug 4, 1998 | K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET Peregrine Surgical , Ltd. | MRH |
| Feb 25, 1998 | K974253 | CPD COMMANDER Scieran Technologies, Inc. | MRH |
| Oct 10, 1997 | K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM Storz Instrument Co. | MRH |
| Sep 19, 1997 | K971067 | DIGI-INJECTOR Medical Instrument Development Laboratories, Inc. | MRH |
| Nov 25, 1996 | K963434 | VISCOUS FLUID SYSTEM Escalon Trek Medical | MRH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.