Chengdu Sani Medical Equipment Co.,Ltd.

Manufacturer

🇨🇳 China·347 Basic UDI-DIs·1139 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

PROHS Equipamento Hospitalar e Serviços Associados S.A.

Manufacturer

🇵🇹 Portugal·45 Basic UDI-DIs·92 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Manufacturer

397 Basic UDI-DIs·511 Devices·6 Importers·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Poriferous, LLC

Manufacturer

🇺🇸 United States·327 Basic UDI-DIs·327 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Vertex-Dental B.V.

Manufacturer

🇳🇱 Netherlands·30 Basic UDI-DIs·51 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ManaFuse

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION 15ML SAMPLE SIZ

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)