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MRCAT Pelvis / RTgo 3

FDA registration
Philips India Limited - Magnetic Resonance Business Unit·1 product·🇮🇳 India

Ingenia Elition X R5.4

FDA registration
Philips India Limited - Magnetic Resonance Business Unit·2 products·🇮🇳 India

MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

FDA 510(k)
FDA Class 2 ·Radiology

HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS

FDA 510(k)
FDA Class 2 ·Radiology

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FLEXITRON

FDA 510(k)
FDA Class 2 ·Radiology

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

FDA 510(k)
FDA Class 2 ·Radiology

FLEXIPLAN 3D AND 3D+

FDA 510(k)
FDA Class 2 ·Radiology

BAIR HUGGER CUB BLANKET- SHORT MODEL 536

FDA 510(k)
FDA Class 2 ·Cardiovascular

SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)

FDA 510(k)
FDA Class 1 ·Physical Medicine

MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

EmbedMed

FDA 510(k)
FDA Class 2 ·Dental

EmbedMed

FDA 510(k)
FDA Class 2 ·Orthopedic

WARD-CSS (v1.2.x)

FDA 510(k)
FDA Class 2 ·Cardiovascular

GOERTEK TECHNOLOGY VINA CO.,LTD

FDA registration
GOERTEK TECHNOLOGY VINA CO.,LTD·1 product·🇻🇳 Vietnam

GOERTEK TECHNOLOGY VINA CO.,LTD

FDA registration
GOERTEK TECHNOLOGY VINA CO.,LTD·1 product·🇻🇳 Vietnam

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD)