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

FDA Pre-Market Approval

FDA Class 3 ·Artic Front Advance Cardiac CryoAblation Catheters

Sharay Anti-GAD IgG (CLIA)

Device

EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

BioCLIA Autoimmune Control Set, GAD

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

BioCLIA Autoimmune Calibrator Set, GAD

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

BioCLIA Autoimmune Reagent Kit, GAD

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

BioCLIA Autoimmune Reagent Kit, GAD

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

SANGO slimline FWD SEGO junior

Device

EU MDR · Eu Md Class 1 ·Dietz Power B.V.·On the market·14 countries

SANGO advanced FWD SEGO basic

Device

EU MDR · Eu Md Class 1 ·Dietz Power B.V.·On the market·14 countries

SANGO advanced FWD SEGO junior

Device

EU MDR · Eu Md Class 1 ·Dietz Power B.V.·On the market·14 countries

SOURCERER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

FDA 510(k)

FDA Class 2 ·Radiology

FLEXILOG 2000

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

FLEXILOG LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXILOG LS 13921

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXILOG 3000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)

FDA 510(k)

FDA Class 1 ·Radiology

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

Lucid Audio

FDA UDI

ETYMOTIC RESEARCH, INC.·00846430005648·Etymotic Live Event HiFi Hearing Protection #20053