HRM

14 FDA 510(k) clearances · Product code

43 daysmedian time to decision

177 days90th percentile

14clearances measured

FDA profile

Official device name: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Device class: Class I (low risk)
Regulation: 21 CFR 878.4700
Medical specialty: General, Plastic Surgery
Adverse events (MAUDE): 2021: 24 · 2022: 17 · 2023: 23 · 2024: 33 · 2025: 56 · 2026: 21
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

Record	Firm	Date
HM-0970 (K932720)	Hill-Med, Inc.	1993-09-07
MARCO SURGISCOPE OPERATION MICROSCOPES (K930439)	Marco Ophthalmic, Inc.	1993-07-22
ALCON OPERATING MICROSCOPES (K920641)	Alcon Laboratories	1992-10-09
KEELER KONAN SPECULAR MICROSCOPE SP5500 (K914956)	Keeler Instruments, Inc.	1992-02-03
S 22 INSTRUMENT STAND (K891584)	Carl Zeiss, Inc.	1989-06-08
MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (K891001)	Prescott'S, Inc.	1989-04-11
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (K854440)	Keeler Instruments, Inc.	1985-12-16
XTAL X-150 OPERATING MICROSCOPE (K853855)	Xtal Corp.	1985-10-15
CROMIC SURGICAL MICROSCOPE MODEL MC-1 (K852586)	Seltrex, Corp.	1985-07-30
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (K852150)	Keeler Instruments, Inc.	1985-06-03
CORNEAL LIGHT SHIELD (K850270)	Mentor O & O, Inc.	1985-05-31
KONAN CLINIC MICROSCOPE CLM-100-150 (K844323)	Keeler Instruments, Inc.	1984-11-21
OPHTHALMIC MICROSCOPE (K822563)	Treace Medical, Inc.	1982-09-14
HAAG-STREIT SLIT LAMP 900 (K792083)	Lumenis, Inc.	1979-11-16

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