TE7 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Hypervisor IX Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Pulse Oximeter (WS20A)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PM-60 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

M5 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

A8, A9 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900

FDA 510(k)

FDA Class 2 ·Radiology

DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular