SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

FDA 510(k)

FDA Class 2 ·Microbiology

BAUMER LOCKING NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

NemoCast

FDA 510(k)

FDA Class 2 ·Dental

EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

KLOCKNER DENTAL IMPLANT, MODEL S3M

FDA 510(k)

FDA Class 2 ·Dental

KLOCKNER DENTAL IMPLANT ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

BAUMER MULLER HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

PulseLavage AB

Manufacturer

🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy

Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer

🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

Nanoxen F2 Hospital Grade Surface disinfectant

FDA registration

NANO COATING TECHNOLOGIES, S.A. DE C.V.·1 product·🇲🇽 Mexico

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS

HAV IgM (CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen New Industries Biomedical Engineering Co., Ltd.·1 device