131 results · 23ms · Sources: EU EUDAMED, US FDA

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BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF: 515105 BD PhaSeal Protector (P50 Multi), REF: 515106 BD PhaSeal Protector (P53), REF: 515107 BD PhaSeal Protector (P55), REF: 515117 BD PhaSeal Connector Luer Lock (C35), REF: 515200 BD PhaSeal Connector Luer Lock (C45), REF: 515202 BD PhaSeal Y-site Connector (C80), REF: 515304 BD PhaSeal L Connector (C90), REF: 515305 BD PhaSeal Infusion Adapter (C100), REF: 515306 BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307 BD PhaSeal Cap for Injector (M50), REF: 515404 BD PhaSeal Connector Cap (M70), REF: 515406 BD PhaSeal Optima Injector (N35-O), REF: 515052 BD PhaSeal Optima Injector (N35-O Multi), REF: 515053 BD PhaSeal Injector Locking (N40-O), REF: 515056 BD PhaSeal Injector Locking (N40-O Multi), REF: 515057 BD PhaSeal Optima Protector (P13-O), REF: 515060 BD PhaSeal Optima Protector (P13-O Multi), REF: 515062 BD PhaSeal Optima Protector (P28-O), REF: 515063 BD PhaSeal Optima Protector (P20-O), REF: 515064 BD PhaSeal Optima Protector (P20-O Multi), REF: 515065 BD PhaSeal Optima Connector (C35-O), REF: 515070 BD PhaSeal Optima Infusion Adapter (C100-O), 515078 BD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079

FDA Enforcement
Class II ·Ongoing·BD SWITZERLAND SARL·September 3, 2025

Swiss Biotech Innovation SA

Manufacturer
🇨🇭 Switzerland

Distalmotion Ltd

Manufacturer
🇨🇭 Switzerland·2 Importers·SGS Belgium NV

AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Manufacturer
🇨🇭 Switzerland

Biosafe S.A.

Manufacturer
🇨🇭 Switzerland·1 Importer

Inpeco SA

Manufacturer
🇨🇭 Switzerland·3 Basic UDI-DIs·7 Devices·1 Importer

MDT Int'l SA

Manufacturer
🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.

Zetta25 AG

Manufacturer
🇨🇭 Switzerland·5 Basic UDI-DIs·6 Devices·1 Importer

PRIMA Lab SA

Manufacturer
🇨🇭 Switzerland·2 Importers

Oculox Technologies SA

Manufacturer
🇨🇭 Switzerland

biped robotics SA

Manufacturer
🇨🇭 Switzerland

ForaCare Suisse AG

Manufacturer
🇨🇭 Switzerland·22 Basic UDI-DIs·23 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Preci Health SA

Manufacturer
🇨🇭 Switzerland

Promedical AG

Manufacturer
🇨🇭 Switzerland

FM Medivid AG

Manufacturer
🇨🇭 Switzerland

DIALIFE SA

Manufacturer
🇨🇭 Switzerland·1 Importer

MEDENA AG

Manufacturer
🇨🇭 Switzerland

Biodenta Swiss AG

Manufacturer
🇨🇭 Switzerland·5 Basic UDI-DIs·5 Devices·TÜV Rheinland LGA Products GmbH

InfinetaMed AG

Manufacturer
🇨🇭 Switzerland

Rontis Corporation SA

Manufacturer
🇨🇭 Switzerland·225 Basic UDI-DIs·443 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o