not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278711229·UDI Software Pristina

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682143516·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682146845·Software Pristina Infinity

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278655141·Software Pristina 8.2 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278795724·Software Pristina 8.3 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278716026·UDI Software Pristina ME 9.1

Force DFX Suture

FDA UDI

DUNAMIS MEDICAL, LLC·00854629006482·Force DFX Suture™ #2 (UHMWPE) 36" HC-5 1/2 Circ...

Force DFX Suture

FDA UDI

DUNAMIS MEDICAL, LLC·00854629006499·Force DFX Suture™ #5 (UHMWPE) 36" HS48 1/2 Circ...

SINMED POSITIONING DEVICES

FDA 510(k)

FDA Class 2 ·Radiology

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target

TrueDent-D

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Stratasys Ltd.·5 devices

RESCUE DRIVER

Basic UDI-DI

EU MDR · Eu Md Class 1 ·OrthoPediatrics Canada ULC·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17