Gentherm Medical, LLC

FDA registration

Gentherm Medical, LLC·1 product·🇺🇸 United States

BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Thermal Regulating

FDA classification

FDA Class 2 ·System, Thermal Regulating

Dynamic Cooling

FDA registration

PRECISION IMPACTS LLC·1 product·🇺🇸 United States

Dynamic Cooling

FDA registration

Candela Corporation·1 product·🇺🇸 United States

micro-albumin in urine, EasyRA assay

FDA registration

MEDICA CORP.·2 products·🇺🇸 United States

Indus

FDA UDI

SPINEFRONTIER, INC.·00190361035787·Indus Invue MAX Symmetrical ACP, 4 Level, 89mm

PIVOTAL HEALTH SOLUTIONS

FDA registration

PIVOTAL HEALTH SOLUTIONS·1 product·🇺🇸 United States

Chronic Total Occlusion Device TruePath CTO Device, TruePath Extension Wire

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA DYNAMIC COOLING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UniTip High Resolution Catheter

FDA UDI

Unisensor AG·07640172973561·

UniTip High Resolution Catheter

FDA UDI

Unisensor AG·07640172973646·

Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

FDA classification

FDA Class 2 ·Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

Micromate

FDA UDI

iSYS Medizintechnik GmbH·09010279000411·The intended use of the Micromate™ device is to...

Powered Laser Surgical Instrument

FDA classification

FDA Class 2 ·Powered Laser Surgical Instrument