Seiler Instrument & Mfg. Co.,Inc.

Saint Louis, MO, US

Seiler Instrument & Mfg. Co.,Inc. appears in FDA device records in Saint Louis, MO. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Seiler Instrument & Mfg. Co.,Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Seiler Instr. & Mfg. Co. Inc.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Seiler Instrument & Mfg. Co.,Inc. in 1988.

Clearances by year, as a table

510(k) clearance decisions for Seiler Instrument & Mfg. Co.,Inc., by decision year
Year	Clearances
1988	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K875124	LOW-POWER BINOCULAR LOUPE	HOH	Substantially Equivalent	1988-02-19

Registered establishments

FDA registered establishments for Seiler Instrument & Mfg. Co.,Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1927430	1927430	Seiler Instrument & Mfg. Co.,Inc.	3433 Tree Court Industrial Blvd, Saint Louis, MO 63122 US	2026	EPT FSP HEX IBJ KEG

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1294-2018	Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.	The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.	Class II	2017-01-01	Open, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Seiler Instrument & Mfg. Co.,Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain