DX BRAINTEST PLUS

Device

EU MDD · Eu Md Class 2a ·Limited Liability Company Research and Production Enterprise "DХ-SYSTEMS"·On the market·1 country

DX M-TEST ONE

Device

EU MDD · Eu Md Class 2a ·Limited Liability Company Research and Production Enterprise "DХ-SYSTEMS"·On the market·1 country

ELECTROENCEPHALOGRAPHS

Device

EU MDD · Eu Md Class 2a ·Limited Liability Company Research and Production Enterprise "DХ-SYSTEMS"·On the market·1 country

GALENICA'S DISPOSABLE ANOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE EXTERNAL CLAMPS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

LIGHTING SOURCE SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DISPOSABLE AMNIOTOME

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P

FDA 510(k)

FDA Unclassified ·Unknown

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology

FDA 510(k)

FDA Unclassified ·Unknown

ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS

FDA 510(k)

FDA Class 2 ·Orthopedic

Finebeam

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

hot cold pack

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Anhui Kamt Ice Pack Co.,Ltd.·17 devices

PT9

FDA UDI

THERMOTEK, INC.·B5850P9PT09SYS0·PT9 Therapy System

VascuTherm5

FDA UDI

THERMOTEK, INC.·B5850P9PTVT5000·VascuTherm5 Therapy System

VascuTherm4

FDA UDI

THERMOTEK, INC.·B5850P9PTVT4000·VascuTherm4 Therapy System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)