Eckert & Ziegler Bebig GmbH

Berlin, DE

ECKERT & ZIEGLER BEBIG GMBH appears in FDA device records in Berlin, DE. FDA records list 5 510(k) clearances between 2000-03-31 and 2015-05-20, 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 Eckert & Ziegler Bebig 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.

Bebig Isotopentechnik GmbH510(k), enforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Eckert & Ziegler Bebig GmbH between 2000 and 2015. The busiest year on record is 2015, with 2. The most recent is 2015, with 2.

Clearances by year, as a table

510(k) clearance decisions for Eckert & Ziegler Bebig GmbH, by decision year
Year	Clearances
2000	1
2013	1
2014	1
2015	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K141900	SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE	MUJ	Substantially Equivalent	2015-05-20
K142986	SagiNova	JAQ	Substantially Equivalent	2015-04-17
K140849	ISOSEED	KXK	Substantially Equivalent	2014-07-02
K123263	HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS	MUJ	Substantially Equivalent	2013-04-04
K993552	ISOSEED PD-103	KXK	Substantially Equivalent	2000-03-31

Registered establishments

FDA registered establishments for Eckert & Ziegler Bebig GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9617477	1000310011	ECKERT & ZIEGLER BEBIG GMBH	ROBERT-ROSSLE STR.10, BERLIN 13125 DE	2026	KXK

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-0517-2024	SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System	Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.	Class II	2023-10-17	Open, Classified

Verification record

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