FDA.reportPublic FDA data

Ophthalmic knife, single-use

Definition
A sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.
GUDID devices
496
Last updated
2023-05-09 06:30:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00084581900232Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4827-TL, B-PE4827-TL2023-04-30
00845819001738Premier Edge® Microsurgical Knives OASIS MEDICAL, INC.PE3832S, B-PE3832S2023-04-30
00845819001813Premier Edge® Microsurgical Knives OASIS MEDICAL, INC.PE3827, B-PE38272023-04-30
00845819001912Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3720A, B-PE3720A2023-04-30
00845819001929Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3720, B-PE37202023-04-30
00845819002018Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3520, B-PE35202023-04-30
00845819002162Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3045, B-PE30452023-04-30
00845819002193Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3022, B-PE30222023-04-30
00845819002216Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3015-5, B-PE3015-52023-04-30
00845819002223Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3015-3, B-PE3015-32023-04-30
00845819002230Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3015, B-PE30152023-04-30
00845819002254Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3012, B-PE30122023-04-30
00845819002285Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4820-TL, B-PE4820-TL2023-04-30
00845819002292Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4822-TL, B-PE4822-TL2023-04-30
00845819002308Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4824-TL, B-PE4824-TL2023-04-30
00845819002315Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4826-TL, B-PE4826-TL2023-04-30
00845819002339Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4828-TL, B-PE4828-TL2023-04-30
00845819002346Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4830-TL, B-PE4830-TL2023-04-30
00845819002353Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4832-TL, B-PE4832-TL2023-04-30
10845819001759Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3832, B-PE38322023-04-30
10845819001773Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3830, B-PE38302023-04-30
10845819001797Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3828, B-PE38282023-04-30
10845819001827Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3826, B-PE38262023-04-30
10845819001834Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3010-SL, B-PE3010-SL2023-04-30
10845819001841Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3825, B-PE38252023-04-30
10845819001858Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3824, B-PE38242023-04-30
10845819001933Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3622, B-PE36222023-04-30
10845819001940Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3630, B- PE36302023-04-30
10845819001957Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3525, B-PE35252023-04-30
10845819001964Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3523A, B-PE3523A2023-04-30
10845819001971Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3523, B-PE35232023-04-30
10845819002008Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3520A, B-PE3520A2023-04-30
10845819002046Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3519A, B-PE3519A2023-04-30
10845819002053Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3519, B-PE35192023-04-30
10845819002060Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3440, B-PE34402023-04-30
10845819002077Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3452, B-PE34522023-04-30
10845819002084Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3230, B-PE32302023-04-30
10845819002107Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3228, B-PE32282023-04-30
10845819002114Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3227, B-PE32272023-04-30
10845819002138Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3226, B-PE32262023-04-30
10845819002183Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3030, B-PE30302023-04-30
10845819002244Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3014, B-PE30142023-04-30
10845819002275Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3010, B-PE30102023-04-30
10845819002558Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3519-SL, B-PE3519-SL2023-04-30
10845819002565Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3015-SL, B-PE3015-SL2023-04-30
10845819002572Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3520A-SL, B-PE3520A-SL2023-04-30
10845819002589Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3520-SL2023-04-30
10845819002633Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3525-SL, B-PE3525-SL2023-04-30
10845819002701Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4815-SL, B-PE4815-SL2023-04-30
10845819002718Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4820-SL, B-PE4820-SL2023-04-30
10845819002732Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4822-SL, B-PE4822-SL2023-04-30
00845819004302Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3127, B-PE31272023-04-30
00845819004326Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3132, B-PE31322023-04-30
10845819002756Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4824-SL, B-PE4824-SL2023-04-30
10845819002787Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4826-SL, B-PE4826-SL2023-04-30
10845819002800Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4827-SL, B-PE4827-SL2023-04-30
10845819002824Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4828-SL, B-PE4828-SL2023-04-30
10845819002855Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4830-SL, B-PE4830-SL2023-04-30
10845819002879Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE4832-SL, B-PE4832-SL2023-04-30
10845819003814Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3300, B- PE33002023-04-30
10845819003821Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3301, B-PE33012023-04-30
10845819003838Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3302, B- PE33022023-04-30
10845819003845Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3303, B-PE33032023-04-30
10845819004279Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3122, B-PE31222023-04-30
10845819004286Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3125, B-PE31252023-04-30
10845819004293Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3126, B-PE31262023-04-30
10845819004316Premier Edge® Microsurgical KnivesOASIS MEDICAL, INC.PE3128, B-PE31282023-04-30
00813059018915Dacrios Opthalmic KnivesDiamatrixD35222023-02-21
74546951601552MANI Ophthalmic KnifeMANI, INC.MST15MK2 Straight 15°MK II2022-09-29
00844685009381TrabEx ProMICROSURGICAL TECHNOLOGY, INC.600050-012022-09-22
74546951400018MANI Ophthalmic KnifeMANI, INC.MST45 Straight 45°2022-08-11
74546951400025MANI Ophthalmic KnifeMANI, INC.MST30 Straight 30°2022-08-11
74546951400056MANI Ophthalmic KnifeMANI, INC.MST15 Straight 15°2022-08-11
74546951400070MANI Ophthalmic KnifeMANI, INC.MCS26 Crescent 2.3mm2022-08-11
74546951400087MANI Ophthalmic KnifeMANI, INC.MCU26 Crescent Bevel Up 2.3mm2022-08-11
74546951400124MANI Ophthalmic KnifeMANI, INC.MSL28 Slit-Angled 2.8mm2022-08-11
74546951400162MANI Ophthalmic KnifeMANI, INC.MSL32 Slit-Angled 3.2mm2022-08-11
74546951400179MANI Ophthalmic KnifeMANI, INC.MSL30 Slit-Angled 3.0mm2022-08-11
74546951400223MANI Ophthalmic KnifeMANI, INC.MVR20 MVR-Lance 20G2022-08-11
74546951400230MANI Ophthalmic KnifeMANI, INC.MVR19 MVR-Lance 19G2022-08-11