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Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES

Bowil Biotech sp. z o.o.

Manufacturer
🇵🇱 Poland·23 Basic UDI-DIs·23 Devices·TUV NORD Polska Sp. z o.o and TUV NORD Polska Sp. z o.o

Enbio Technology Sp. z o. o.

Manufacturer
🇵🇱 Poland·2 Basic UDI-DIs·22 Devices·TUV NORD Polska Sp. z o.o and TUV NORD Polska Sp. z o.o

Syntropiq s.r.o.

Manufacturer
🇨🇿 Czechia·2323 Basic UDI-DIs·2323 Devices·TUV NORD Polska Sp. z o.o and TUV NORD Polska Sp. z o.o

VELOX

FDA registration
MEDAX S.R.L. UNIPERSONALE·1 product·🇮🇹 Italy

Sharper Image Massager Duo Compression with Dual-Node Vibration

FDA registration
U YOUNG APPLIANCE MANUFACTURING (XIAMEN) CO., LTD.·1 product·🇨🇳 China

MENIX® DUO Meniscal Suture System, 2 anchors ; Catalog Number MEN0201901

FDA registration
SCIENCE & BIO MATERIALS, S.B.M. SAS·1 product·🇫🇷 France

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP and Therap

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther

SUNGLASSES

FDA 510(k)
FDA Class 1 ·Ophthalmic

MTS Pelvic Reconstruction Kit

FDA UDI
MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430106118·

PURIST

FDA UDI
ADSM·03701091005475·OLH - DENYER PLUS

Hillrom™

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761985674·Trumpf Medical/Medizin Leather extension sandal...

Head Sections

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761970298·Head section double joint H U V

Pelvis Sections

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761970250·Pelvic extension H V

Hillrom™

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761988972·Trumpf Medical/Medizin Additional pad II pair

Trumpf Medical

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761979994·Universal section H V UK

Extension frame for lateral and prone positions

FDA UDI
MAQUET GmbH·04046768132467·