2,979 results · 46ms · Sources: EU EUDAMED, US FDA

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T

170726773

Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs

059786 MR2 170726773

Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs

ACCELOGRAPH

FDA 510(k)
FDA Class 2 ·Anesthesiology

TOF-GUARD TRANSMISSION MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL

FDA 510(k)
FDA Class 2 ·Physical Medicine

MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

MYOTEST DBS NERVE STIMULATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING

FDA 510(k)
FDA Class 2 ·Anesthesiology

ELPHA 2000

FDA 510(k)
FDA Class 2 ·Physical Medicine

MYOTEST - NERVE STIMULATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BIOMERIEUX THXID BRAF ASSAY KIT

Medical Monitor

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.,Ltd·1 device

Digital Electronic Colposcope

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.,Ltd·2 devices

Endoscope Camera (FULL HD Endoscope System; 4K Medical Endoscope Camera System)

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.,Ltd·13 devices

D/Km-1, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·D/Km-1, Antigen, Antiserum, Control

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT