Wellspect Healthcare

Molndal Vastra Gotaland, SE

Wellspect Healthcare appears in FDA device records in Molndal Vastra Gotaland, SE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Wellspect Healthcare 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.

Wellspect HealthCare (Division of DENTSPLY IH AB)enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Wellspect Healthcare in 2013.

Clearances by year, as a table

510(k) clearance decisions for Wellspect Healthcare, by decision year
Year	Clearances
2013	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K123751	LOFRIC SENSE	EZD	Substantially Equivalent	2013-02-28

Registered establishments

FDA registered establishments for Wellspect Healthcare, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3009632672	3009632672	Wellspect Healthcare	Aminogatan 1, Molndal Vastra Gotaland SE-43121 SE	2026	DZE EZC EZD FBX FCE KNT LXB MAH NDP NHA and 2 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-2645-2020	LoFric Origo, Tiemann, 16in, FR14 urinary catheters	Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.	Class II	2020-06-17	Terminated
Z-2644-2020	LoFric Origo, Tiemann, 16in, FR12 urinary catheters	Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.	Class II	2020-06-17	Terminated
Z-2643-2020	LoFric Origo, Nelaton, 16in, FR10 urinary catheters	Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.	Class II	2020-06-17	Terminated

Verification record

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