Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of NordsonLabelled by claude-sonnet-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 Quest Medical, Inc. with 39 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Dec 18, 2024: Lyka® PORT Needle Free Access Device (4170Y).
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.
| Dec 18, 2024 | Lyka® PORT Needle Free Access Device (4170Y)K241058 · FPA | 510(k) clearances |
| Jul 14, 2023 | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV Class II · For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifo | Device recalls |
| Dec 23, 2022 | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2Class II · Delivery Sets may have tubing that could become detached that could result in patient infection. | Device recalls |
| Jun 5, 2022 | Q2 Blood Administration SetsK213846 · FPA | 510(k) clearances |
| Jun 2, 2022 | Q2 IV Administration SetsK213588 · FPA | 510(k) clearances |
| Jan 21, 2021 | Precision Delivery Infusion SetK202672 · FPA | 510(k) clearances |
| Nov 20, 2020 | MPS 3 ND Myocardial Protection SystemK201984 · DTR | 510(k) clearances |
| Jun 19, 2020 | MPS 3 Myocardial Protection SystemK200438 · DTR | 510(k) clearances |
| Dec 17, 2019 | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a componentClass II · Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top | Device recalls |
| Nov 6, 2018 | MiniGuard Arterial Safety ValveK182442 · MJJ | 510(k) clearances |
| Oct 1, 2018 | MPS2 Myocardial Protection System ConsoleK173716 · DTR | 510(k) clearances |
| Oct 28, 2015 | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS DeliveryClass II · The products have been found to intermittently exhibit a seal failure during use. | Device recalls |
| Feb 26, 2015 | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.Class II · Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels | 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
