FDA.reportPublic FDA data

Surgical binoculars, reusable

Definition
A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.
GUDID devices
1,388
Last updated
2026-08-18 06:11:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00814005023304M-2.5 FlipQUALITY ASPIRATORS, INC.M-2.5 Flip2025-02-27
00814005023311M-2.5 TTLQUALITY ASPIRATORS, INC.M-2.5 TTL2025-02-27
00814005023328M-3.0 FlipQUALITY ASPIRATORS, INC.M-3.0 Flip2025-02-27
00814005023335M-3.0 TTLQUALITY ASPIRATORS, INC.M-3.0 TTL2025-02-27
00814005023342M-3.5 FlipQUALITY ASPIRATORS, INC.M-3.5 Flip2025-02-27
00814005023359M-3.5 TTLQUALITY ASPIRATORS, INC.M-3.5 TTL2025-02-27
00814005023458P-3.5 TTLQUALITY ASPIRATORS, INC.P-3.5 TTL2025-02-27
00814005023465P-4.0 TTLQUALITY ASPIRATORS, INC.P-4.0 TTL2025-02-27
00814005023472P-4.5 TTLQUALITY ASPIRATORS, INC.P-4.5 TTL2025-02-27
00814005023496Prism Combo CaseQUALITY ASPIRATORS, INC.Prism Combo Case2025-02-27
00814005023502Q877QUALITY ASPIRATORS, INC.Q8772025-02-27
00814005023519Q879QUALITY ASPIRATORS, INC.Q8792025-02-27
00814005024196F-3.0 TTLQUALITY ASPIRATORS, INC.F-3.0 TTL2025-02-27
00814005024219EP-3.5 TTLQUALITY ASPIRATORS, INC.EP-3.5 TTL2025-02-27
00814005024226EP-4.0 TTLQUALITY ASPIRATORS, INC.EP-4.0 TTL2025-02-27
00814005024233EP-4.5 TTLQUALITY ASPIRATORS, INC.EP-4.5 TTL2025-02-27
00814005024240Q-Optics Loupe CaseQUALITY ASPIRATORS, INC.Q-Optics Loupe Case2025-02-27
00814005024318SVRXQUALITY ASPIRATORS, INC.SVRX2025-02-27
00814005024325BRXQUALITY ASPIRATORS, INC.BRX2025-02-27
00814005024332Q-Optics Loupe and Light Combo CaseQUALITY ASPIRATORS, INC.Q-Optics Loupe and Light Combo Case2025-02-27
00814005024530FILTER 5151QUALITY ASPIRATORS, INC.FILTER 51512025-02-27
00814005024561Eclipse TiQUALITY ASPIRATORS, INC.Eclipse Ti2025-02-27
00814005024578Eclipse-QDNPQUALITY ASPIRATORS, INC.Eclipse-QDNP2025-02-27
00814005024608FILTER 5801QUALITY ASPIRATORS, INC.FILTER 58012025-02-27
00814005024615FILTER PI11QUALITY ASPIRATORS, INC.FILTER PI112025-02-27
00814005024622FILTER PI4QUALITY ASPIRATORS, INC.FILTER PI42025-02-27
00814005024639FILTER PN10QUALITY ASPIRATORS, INC.FILTER PN102025-02-27
00814005024691Side Shield for Q877QUALITY ASPIRATORS, INC.Side Shield for Q8772025-02-27
00814005024707Side Shield for Q879QUALITY ASPIRATORS, INC.Side Shield for Q8792025-02-27
00814005024714Face Shield 2 (FS-2) AssyQUALITY ASPIRATORS, INC.Face Shield 2 (FS-2) Assy2025-02-27
00814005024769Strap 1QUALITY ASPIRATORS, INC.Strap 12025-02-27
00814005024783Strap 3QUALITY ASPIRATORS, INC.Strap 32025-02-27
00814005024790Lens Cleaning Spray (LC)QUALITY ASPIRATORS, INC.Lens Cleaning Spray (LC)2025-02-27
00814005024813Temple Arm CoverQUALITY ASPIRATORS, INC.Temple Arm Cover2025-02-27
00814005024905Q-3500 Eclipse Ti-130QUALITY ASPIRATORS, INC.Q-3500 Eclipse Ti-1302025-02-27
00814005024912Q-3500 Eclipse Ti-150QUALITY ASPIRATORS, INC.Q-3500 Eclipse Ti-1502025-02-27
00814005024929Q-Optics Microfiber Cleaning ClothQUALITY ASPIRATORS, INC.Q-Optics Microfiber Cleaning Cloth2025-02-27
00814005025315Panto-51QUALITY ASPIRATORS, INC.Panto-512025-02-27
00814005025322Panto-53QUALITY ASPIRATORS, INC.Panto-532025-02-27
00814005025339Panto-55QUALITY ASPIRATORS, INC.Panto-552025-02-27
00814005025346Eclipse-130QUALITY ASPIRATORS, INC.Eclipse-1302025-02-27
00814005025353Eclipse-138QUALITY ASPIRATORS, INC.Eclipse-1382025-02-27
00814005025360Eclipse-146QUALITY ASPIRATORS, INC.Eclipse-1462025-02-27
00814005025391Classic-56QUALITY ASPIRATORS, INC.Classic-562025-02-27
00814005025407Classic-61QUALITY ASPIRATORS, INC.Classic-612025-02-27
00814005025414Short Vented Nose Pad with BridgeQUALITY ASPIRATORS, INC.Short Vented Nose Pad with Bridge2025-02-27
00814005025421Long Vented Nose Pad with BridgeQUALITY ASPIRATORS, INC.Long Vented Nose Pad with Bridge2025-02-27
00814005025452EP-3.0 TTLQUALITY ASPIRATORS, INC.EP-3.0 TTL2025-02-27
06945095556015zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556022zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556039zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556046zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556053zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556060zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556077zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556084zumaxZumax Medical Co., LTDSLT2026-07-06
06945095556091zumaxZumax Medical Co., LTDSLD2026-07-06
06945095541110zumaxZumax Medical Co., LTDSLE2026-06-03
06945095541424zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541448zumaxZumax Medical Co., LTDSLF2026-06-03
06945095541929zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541936zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541943zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541950zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541967zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541974zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541981zumaxZumax Medical Co., LTDSLT2026-06-03
06945095541998zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542001zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542018zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542025zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542032zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542049zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542056zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542063zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542070zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542087zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542094zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542100zumaxZumax Medical Co., LTDSLT2026-06-03
06945095542117zumaxZumax Medical Co., LTDSLT2026-06-03