Spiggle & Theis Medizintechnik GmbH

OVERATH North Rhine-Westphalia, DE

SPIGGLE & THEIS MEDIZINTECHNIK GMBH appears in FDA device records in OVERATH North Rhine-Westphalia, DE. 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 Spiggle & Theis Medizintechnik 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.

Spiggle & Theis Mt Gmbhenforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Spiggle & Theis Medizintechnik GmbH in 2023.

Clearances by year, as a table

510(k) clearance decisions for Spiggle & Theis Medizintechnik GmbH, by decision year
Year	Clearances
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K223542	TubaVent Balloon Dilatation System	PNZ	Substantially Equivalent	2023-08-03

Registered establishments

FDA registered establishments for Spiggle & Theis Medizintechnik GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3002858762	3002858762	SPIGGLE & THEIS MEDIZINTECHNIK GMBH	Burghof 14, OVERATH North Rhine-Westphalia 51491 DE	2026	BRW BWN BYY CCW EBA EMX EPP EPW EPY EQH and 52 more, listed in full below

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-2331-2025	Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile	Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.	Class II	2025-06-27	Open, Classified

Verification record

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