Quest Medical, Inc.
Quest Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2024, with 5 FDA device recalls on record.
Top product codes for Quest Medical, Inc.
FDA recalls by Quest Medical, Inc.
- Z-0197-2024 — Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
- Z-1100-2023 — Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
- Z-2107-2020 — 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 component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
- Z-0361-2016 — Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
- Z-1368-2015 — LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Quest Medical, Inc.
- K241058 — Lyka® PORT Needle Free Access Device (4170Y)
- K213846 — Q2 Blood Administration Sets
- K213588 — Q2 IV Administration Sets
- K202672 — Precision Delivery Infusion Set
- K201984 — MPS 3 ND Myocardial Protection System
- K200438 — MPS 3 Myocardial Protection System
- K182442 — MiniGuard Arterial Safety Valve
- K173716 — MPS2 Myocardial Protection System Console
- K162804 — Q2 Low Pressure Power Injection Extension Set
- K162304 — Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
- K151079 — Q2 Intravenous Adminstration Sets and Extension Sets
- K113867 — LACRICATH LACRIMAL DUCT CATHETER
- K113118 — STENTUBE LACRIMAL INTUBATION SET
- K041979 — MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
- K040385 — MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
- K002689 — SWABSITE SWABBABLE VALVE, MODEL 245000
- K002366 — QUEST MPS BACK-UP SYSYEM
- K994274 — QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
- K971928 — QUEST VESSEL CATHETER
- K955818 — FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER
- K953838 — MYOCARDIAL PROTECTION SYSTEM
- K952531 — QUEST VEIN GRAFT PERFUSION SET
- K951088 — QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS
- K950814 — QUEST ANTEGRADE CARDIOPLEGIA CANNULA
- K941916 — QUEST CORONARY SINUS PERFUSION CANNULA -FRCC
- K941166 — QUEST CORONARY SINUS PERFUSION CANNULA
- K925049 — QUEST HEART INSULATION PAD
- K860157 — NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
- K851017 — QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
- K841361 — SYRINGE ADDITIVE IV ADMIN. SETS
- K834528 — MODEL 2001 INTELLIGENT INFUSOR
- K830472 — LIPOSOL
- K823404 — VOLUMERIC CONTROLLER
- K822216 — VOLUMETRIC CONTROLLER
- K820699 — CATHETER GUIDE WIRE
- K813606 — SILICONE ELASTOMER INFUSION CATHETER
- K811685 — I.V. ADMINISTRATION SET
- K800825 — EXTENSION SET QUEST CODE #3000
- K800786 — INJECTION SITE, CODE NO. 3100
Data sourced from openFDA. This site is unofficial and independent of the FDA.