Science & Bio Materials, S.B.M. SAS

LOURDES Hautes-Pyrenees, FR

SCIENCE & BIO MATERIALS, S.B.M. SAS appears in FDA device records in LOURDES Hautes-Pyrenees, FR. FDA records list 2 510(k) clearances between 2023-07-26 and 2025-06-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Science & Bio Materials, S.B.M. SAS 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.

SCIENCE & BIO MATERIALSenforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Science & Bio Materials, S.B.M. SAS between 2023 and 2025. The busiest year on record is 2023, with 1. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Science & Bio Materials, S.B.M. SAS, by decision year
Year	Clearances
2023	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K250844	PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop	MBI	Substantially Equivalent	2025-06-02
K231787	ecoFIX®	MAI	Substantially Equivalent	2023-07-26

Registered establishments

FDA registered establishments for Science & Bio Materials, S.B.M. SAS, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004549189	3004051158	SCIENCE & BIO MATERIALS, S.B.M. SAS	ZI DU MONGE, LOURDES Hautes-Pyrenees 65100 FR	2026	FSM GAT HRS HTW HWC HWX HXX HXZ LXH MAI 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-1718-2025	Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)	Vials of implant bone granules may contain less product then specified on labeling.	Class II	2025-04-07	Open, Classified
Z-1361-2022	ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605	Mislabeled product.	Class II	2021-10-07	Completed

Verification record

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