Data / Medical devices / Japan / Inami & Co., Ltd.

Inami & Co., Ltd.: FDA-registered device maker in Bunkyo Tokyo, Japan, 3 510(k) clearances

Name: Inami & Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Inami & Co., Ltd. is registered with the FDA (registration 9612297) in Bunkyo Tokyo, Japan. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 1990. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9612297
FEI number: 3002809378
Address: 24-2, Hongo, 3-Chome, Bunkyo Tokyo, Japan, 113-0033
Owner or operator: INAMI & CO., LTD. (8030429)
Roles: Manufacturer
First device listed: March 14, 1984
Registered through: 2026
Brand names listed: BEAM SPLITTER, DEGITAL CAMERA 3.2MB, Hanemoto Round Divider, INAMI, INAMI & CO, INAMI & CO., LTD.., INAMI TANITO HOOK, K-0161 Exophthalmometer, HERTEL and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer	accessdata.fda.gov
Brush, Haidinger, (Including Macular Integrity)	HIY	1	Manufacturer	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Manufacturer	accessdata.fda.gov
Chair, Ophthalmic, Manual	HMD	1	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer	accessdata.fda.gov
Depressor, Orbital	HNX	1	Manufacturer	accessdata.fda.gov
Device, Measuring, Lens Radius, Ophthalmic	HLF	1	Manufacturer	accessdata.fda.gov
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System	NVV	1	Manufacturer	accessdata.fda.gov
Exophthalmometer	HLS	1	Manufacturer	accessdata.fda.gov
Eye, Artificial, Non-Custom	HQH	1	Manufacturer	accessdata.fda.gov
Frame, Trial, Ophthalmic	HPA	1	Manufacturer	accessdata.fda.gov
Grid, Amsler	HOQ	1	Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instrument, Measuring, Corneal Radius	HJB	1	Manufacturer	accessdata.fda.gov
Instrument, Measuring, Lens, Ac-Powered	HLM	1	Manufacturer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Manufacturer	accessdata.fda.gov
Perimeter, Manual	HON	1	Manufacturer	accessdata.fda.gov
Probe, Trabeculotomy	HNK	1	Manufacturer	accessdata.fda.gov
Projector, Ophthalmic	HOS	1	Manufacturer	accessdata.fda.gov
Pupillometer, Manual	HLH	1	Manufacturer	accessdata.fda.gov
Refractor, Manual, Non-Powered, Including Phoropter	HKN	1	Manufacturer	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Manufacturer	accessdata.fda.gov
Set, Lens, Trial, Ophthalmic	HPC	1	Manufacturer	accessdata.fda.gov
Simulatan (Including Crossed Cylinder)	HOR	1	Manufacturer	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Manufacturer	accessdata.fda.gov
Stand, Instrument, Ophthalmic, Non-Powered	HMG	1	Manufacturer	accessdata.fda.gov
Stereoscope, Ac-Powered	HJQ	1	Manufacturer	accessdata.fda.gov
Tonometer, Ac-Powered	HKX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 21, 1990	K900477	WOODLYN CLASSIC SLIT LAMP MODEL SMM	HJO	Substantially Equivalent	Woodlyn, Inc.	accessdata.fda.gov
February 21, 1990	K900476	WOODLYN SLIT LAMP MODEL HR-1	HJO	Substantially Equivalent	Woodlyn, Inc.	accessdata.fda.gov
August 2, 1984	K841762	WOODLYN APPLANATION TONOMETER	HKX	Substantially Equivalent	Woodlyn, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 21, 1990. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.