Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list GA Health Company with 12 510(k) clearances and 11 device recalls. The most recent is a 510(k) clearance dated Oct 16, 2023: ANDORATE® Valve Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 16, 2023 | ANDORATE® Valve KitK232118 · ODC | 510(k) clearances |
| Aug 1, 2023 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingK231602 · OCX | 510(k) clearances |
| Jul 7, 2023 | ANDORATE® Valve KitK230932 · OCX | 510(k) clearances |
| May 11, 2023 | ANDORATE® Suction Valve and ANDORATE® Biopsy ValveK230280 · KTI | 510(k) clearances |
| Nov 10, 2022 | AquaPulse® Irrigation TubingK223171 · OCX | 510(k) clearances |
| Jan 12, 2022 | andorate Suction Valve, andorate Air/Water ValveK213095 · ODC | 510(k) clearances |
| Mar 5, 2021 | Andorate Universal Endoscope Tip GuardK202838 · OCU | 510(k) clearances |
| Dec 10, 2020 | AquaPulse Irrigation TubingK202560 · OCX | 510(k) clearances |
| Nov 3, 2020 | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product CodeClass II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846Class II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAClass II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004Class II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046Class II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102Class II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Class II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
| Nov 3, 2020 | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4Class II · Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
