Dr. Franz Kohler Chemie GmbH

BENSHEIM Hesse, DE

DR. FRANZ KOHLER CHEMIE GMBH appears in FDA device records in BENSHEIM Hesse, DE. FDA records list 5 510(k) clearances between 1999-12-10 and 2020-04-24, 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: 5
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Dr. Franz Kohler Chemie GmbH 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.

Dr Franz Koehler Chemie Gmbhenforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Dr. Franz Kohler Chemie GmbH between 1999 and 2020. The busiest year on record is 1999, with 1. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Dr. Franz Kohler Chemie GmbH, by decision year
Year	Clearances
1999	1
2003	1
2004	1
2005	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K192408	Custodiol HTK Solution	KDL	Substantially Equivalent	2020-04-24
K043461	CUSTODIOL	KDL	Substantially Equivalent	2005-02-28
K032794	CUSTODIOL	MSB	Substantially Equivalent	2004-04-05
K020924	CUSTODIOL HTK SOLUTION	KDL	Substantially Equivalent	2003-01-06
K992209	CUSTODIOL	KDN	Substantially Equivalent	1999-12-10

Registered establishments

FDA registered establishments for Dr. Franz Kohler Chemie GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9615922	3001640191	DR. FRANZ KOHLER CHEMIE GMBH	WERNER-VON-SIEMENS-STR. 14-28, BENSHEIM Hesse D-64625 DE	2026	KDL KDN MSB

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-3300-2024	Custodiol HTK Solution, 500ml bottle. 10 per carton.	Potential for particles to be present in solution.	Class II	2024-01-09	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 Dr. Franz Kohler Chemie GmbH 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