3,005 results · 44ms · Sources: EU EUDAMED, US FDA

CLEARBLUE EASY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALBUMIN IN SERUM

FDA 510(k)
FDA Class 2 ·Immunology

CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OXOID INFECTIOUS MONONUCLEOSIS KIT

FDA 510(k)
FDA Class 2 ·Immunology

CLEARVIEW C. DIFF A

FDA 510(k)
FDA Class 1 ·Microbiology

HAPTOGLOBIN

FDA 510(k)
FDA Class 2 ·Immunology

IMMUNOGLOBULINS M

FDA 510(k)
FDA Class 2 ·Immunology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Attain Bipolar OTW/Attain OTW LV Lead; Consulta/Percepta Bipolar/Percepta Quadripolar/Serena Bipolar/Serena Quadripolar/

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK

Ethyl Glucuronide (ETG) Rapid Test Kit (Urine)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

Ethyl Glucuronide (ETG) Rapid Test Kit (Urine)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

ETG Rapid Test Kit (Colloidal gold method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·1 device

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX ICDS/COROX OTW UP STEROID

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ACS OTW PHOTON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·NC STORMER OTW BALLOON DILATATION CATHETER

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·OVATIO CRT & SITUS OTW LV

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·OVATIO CRT & SITUS OTW LV

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ACS OTW PHOTON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 4193 ATTAIN OTW LEAD