R3THA for Wellness

FDA registration

NEUROTECHR3 INC.·1 product·🇺🇸 United States

CareView 1500Cw X-Ray Flat Panel Detectors

FDA registration

COMPASS INNOVATIONS, INC·1 product·🇺🇸 United States

C Scope Visualization System

FDA registration

CIT ORTHO·1 product·🇺🇸 United States

BioStar® Transbronchial Aspiration Needle

FDA registration

HANGZHOU BRONCUS MEDICAL CO., LTD.·1 product·🇨🇳 China

CareView 1800R

FDA registration

COMPASS INNOVATIONS, INC·1 product·🇺🇸 United States

Porcelain-fused-to-metal Restoration

FDA registration

Elite Dental Lab Limited·1 product·🇭🇰 Hong Kong

Partial Dentures

FDA registration

Elite Dental Lab Limited·1 product·🇭🇰 Hong Kong

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOFIRE FILMARRAY Pneumonia Panel

FDA registration

BioFire Diagnostics, LLC·2 products·🇺🇸 United States

MAXUM

FDA UDI

Ototronix, LLC·M737M70131·PICK, SHARP FINE RIGHT ANGLE

Esteem® Intraoperative System Analyzer

FDA UDI

Envoy Medical Corporation·00812282020436·Intraoperative System Analyzer (ISA), Sterile C...

Esteem® Intraoperative System Analyzer

FDA UDI

Envoy Medical Corporation·00812282020177·Intraoperative System Analyzer (ISA), Patient I...

MAXUM

FDA UDI

Ototronix, LLC·M737M61021·Packaged OptiMAX Software

Esteem® Laser Reflector

FDA UDI

Envoy Medical Corporation·00812282020320·Laser Reflector

MAXUM

FDA UDI

Ototronix, LLC·M737M420L1·IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, LEFT

Esteem® Sound Processor

FDA UDI

Envoy Medical Corporation·00812282020214·Sound Processor Model 2001, IS-1 Connector Ports

Esteem® MedCem®

FDA UDI

Envoy Medical Corporation·00812282020276·MedCem® Hydroxyapatite Cement

Esteem® Tapered Syringe Tips

FDA UDI

Envoy Medical Corporation·10812282020242·Tapered Syringe Tips, Qty 5