VANCE CYSTOSCOPIC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHFINDER 700 HOLTER ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

KardiaAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUINTON Q.CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

DeepRhythmAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSENSOR HOLTER MONITOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAMBRIDGE HEART OEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rhythmia HDxTM Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS PATHFINDER SL HOLTER ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENDYS MODEL 5000 B/BC

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZYMED HOLTER SCANNER MODEL 2010

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL TX-8 PANENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AutoMark Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular