17 results · 51ms · Sources: EU EUDAMED, US FDA

Panther Fusion Extraction Reagent-S 960 Tests

FDA registration
Hologic, Inc.·2 products·🇺🇸 United States

Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes

FDA 510(k)
FDA Class 2 ·Microbiology

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification
FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System

12SL ECG Analysis Program

FDA registration
GE Medical Systems Information Technologies, Inc.·1 product·🇺🇸 United States

ISOMEDIX OPERATIONS INC.

FDA registration
ISOMEDIX OPERATIONS INC.·1 product·🇺🇸 United States

Vented Vial Access Device w Smartsite

FDA registration
ROBLING MEDICAL, INC.·1 product·🇺🇸 United States

Yukon Medical, LLC

FDA registration
Yukon Medical, LLC·1 product·🇺🇸 United States

Bard Mission Disposable Core Biopsy Instrument

FDA registration
CareFusion D.R. 203 Ltd.·1 product·🇩🇴 Dominican Republic

Cardinal Health

FDA registration
Cardinal Health·1 product·🇺🇸 United States

Sterigenics US LLC

FDA registration
Sterigenics US LLC·1 product·🇺🇸 United States

GFA Production Xiamen Co., Ltd.

FDA registration
GFA Production Xiamen Co., Ltd.·1 product·🇨🇳 China

MagPro

FDA UDI
Tonica Elektronik A/S·05713484020437·Magnetic coil for he Axilum Robotics’ TMS-Cobot...

BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO: ARTHROCARE ARTHROWANDS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Catheter, Percutaneous

FDA classification
FDA Class 2 ·Catheter, Percutaneous

Electrosurgical, Cutting & Coagulation & Accessories

FDA classification
FDA Class 2 ·Electrosurgical, Cutting & Coagulation & Accessories