CHAMP-PAQ VINYL PATIENT EXAM GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

RapidFor™ PGB Detection Kit (Urine) (FIA)

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RZ Tunneling Drill

FDA registration

RAZEK EQUIPAMENTOS LTDA·1 product·🇧🇷 Brazil

Razek Arthroscopy Cannulas

FDA registration

RAZEK EQUIPAMENTOS LTDA·1 product·🇧🇷 Brazil

Mini Microdebridement Cannula - ENTM

FDA registration

RAZEK EQUIPAMENTOS LTDA·1 product·🇧🇷 Brazil

Razek MTSL Instruments

FDA registration

RAZEK EQUIPAMENTOS LTDA·1 product·🇧🇷 Brazil

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR FAMILY OF PULSE GENERATORS (PGS)

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

FDA 510(k)

FDA Class 2 ·Dental

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Optisure

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant ™ HF, Entrant™ HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril STS, UltiPace

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Aveir Leadless System

ACCURUN®

FDA UDI

Lgc Clinical Diagnostics, Inc.·00816784020130·ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL

Total Protein UrineCSF Gen3

FDA UDI

Roche Diagnostics GmbH·04015630919536·

ACCURUN®

FDA UDI

Lgc Clinical Diagnostics, Inc.·00816784020147·ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL