Atlas FDA

HMX

77 FDA 510(k) clearances · Product code

90 daysmedian time to decision
133 days90th percentile
77clearances measured

FDA profile

Official device name
Cannula, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2021: 41 · 2022: 46 · 2023: 93 · 2024: 102 · 2025: 110 · 2026: 66
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
WEISS RETINAL CANNULA (K010305)Micron Surgical, Inc.2001-05-02
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES (K000457)Retinalabs.Com2000-05-09
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (K970873)American Medical Devices, Inc.1997-05-20
STERISEAL OPHTHALMIC CANNULA (K943932)Pharma-Plast, Ltd.1995-01-18
INFUSION CANNULA (K942403)Microsurgical Technology, Inc.1994-08-17
INTER TIP T (K934844)Microsurgical Technology, Inc.1994-04-19
KIRWAN IRRIGATION/ASPIRATION HANDPIECE (K930113)Kirwan Surgical Products, Inc.1994-02-17
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (K921488)Surgical Technologies, Inc.1992-05-07
IRRIGATOR/ASPIRATOR PROBE (K915074)Biomedical Dynamics, Inc.1992-02-05
VITREORETINAL INFUSION CANNULA (K904074)Visitec Co.1991-02-26
OCULAR INFUSION CANNULA SYSTEM (K901618)Tamcenan Corp.1990-05-31
GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) (K890782)Grieshaber & Co.1989-06-23
STORZ INFUSION CANNULA (K882884)Storz Instrument Co.1988-08-04
CANNULAS (K880346)Myocure, Inc.1988-05-03
ANESTHESIA/RETROBULBAR NEEDLES (K880347)Myocure, Inc.1988-05-03
OCU-1 (K875030)Rudolph Beaver, Inc.1988-05-03
OPHTHALMIC CANNULA (K881487)Surgical Instrument, Inc.1988-04-29
PRISMA DISPOSABLE SIMCOE I/A CANNULA (K874973)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE J-SHAPED I/A CANNULA (K874981)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER (K874974)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE ANGLED I/A CANNULA (K874994)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA (K874972)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA (K874970)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA. (K874996)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOS. CURVED LACHRYMAL CANNULA (K874995)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER (K874980)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS (K874989)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED (K874977)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE DOUBLE I/A CANNULA (K874987)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE PUPIL CENTERING CANNULA (K875003)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SILICONE BULB (K874990)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SIMCOE EXTRACTOR (K874982)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA (K874968)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA (K874978)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE CAPSULE POLISHER (K874985)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE (K874999)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE MICRO IRRIGATING VECTUS (K874984)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE U-SHAPED CANNULA (K874998)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS (K874971)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA (K875002)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT (K874988)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE RETROBULBAR NEEDLE (K874986)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER (K874969)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE IRRIGATING LENS DIALER (K874992)Advanced Surgical Products, Inc.1988-04-13
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0 (K873853)Advanced Surgical Products, Inc.1988-03-07
VAN DELLEN RETROBULBAR NEEDLE (K873162)Van Dellen, Ltd.1987-09-04
VAN DELLEN HEALON CANNULA (K873164)Van Dellen, Ltd.1987-09-04
LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH (K872884)Look, Inc.1987-08-10
SOLOS EYESITE CANNULAS (K872610)Solos Ophthalmology1987-07-31
HAMACHER BULLET POINT OPHTHALMIC NEEDLE (K872200)R. J. Doyle, Inc.1987-06-25
OPHTHALMIC CANNULA (K872151)Pharmacia, Inc.1987-06-19
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA (K871605)Advanced Surgical Products, Inc.1987-06-19
LOOK RETROBULBAR NEEDLES (K870902)Look, Inc.1987-03-20
LOOK IRRIGATING CANNULAS (K870438)Look, Inc.1987-02-20
LOOK IRRIGATING/ASPIRATING CANNULAS (K870436)Look, Inc.1987-02-20
LOOK CORTEX EXTRACTORS (K870441)Look, Inc.1987-02-20
IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES (K861545)Rophae Lens Co., Inc.1986-05-28
OPTHALMIC SURGICAL INSTRUMENTS (K860744)Tridak Division of Indicon, Inc.1986-03-31
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA (K854506)Storz Instrument Co.1986-02-07
THE NEW MCINTYRE I.A. HANDPIECE (K854402)Microsurgical Technology, Inc.1985-12-30
THE NEW MOBILE TIP MCINTYRE CANNULA (K854401)Microsurgical Technology, Inc.1985-12-30
THE NEW MCINTYRE CANNULA (K853777)Microsurgical Technology, Inc.1985-11-21
INFUSION CANNULAM (K852758)Precision Medical Instruments, Inc.1985-08-01
SITE ANTERIOR CAPSULOTOMER (K843039)Chiron Vision Corp.1984-11-21
STERILIZED DISPOS. CYSTOTOME (K840442)Microsurgical Technology, Inc.1984-03-16
OCULAR IRRIGATING CANNULA (K831532)Dey Laboratories, Inc.1983-07-12
INFUSION CANNULA (K831192)Medical Instrument Development Laboratories, Inc.1983-06-30
NLD IMPLANT SET (K813314)Design Research Assoc., Inc.1982-02-24
OMS INFUSION CANNULA ASSEMBLE (K813481)Optical Micro Systems, Inc.1982-01-22
KOI LACRIMAL INTUBATION SYSTEM (K812010)Koi, Inc.1981-07-28
ANIS GUIDING CANNULA (K811455)American V. Mueller1981-06-16
MAY ILLUMINATED/INFUSION PIC (K801411)Cooper Medical Devices Corp.1980-07-21
X-PAK (K791917)Contemporary Surgical Systems, Inc.1979-10-30
CANNULA'S CAT #'S 6636, 6624, 6625 (K791982)Edward Weck, Inc.1979-10-04
NEEDLES, CANNULAS, CYSTOTOMES (K782169)Visitec Co.1979-02-13
CANNULAS (K790243)Visitec Co.1979-02-12
IRRIGATION/ASPIRATION NEEDLE (K771416)Concept, Inc.1977-09-12

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Every clearance here is in the API, with alerts when new ones post.