120 results · 22ms · Sources: EU EUDAMED, US FDA

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ePM Series Patient monitors

FDA 510(k)
FDA Class 2 ·Cardiovascular

Paradigm

FDA UDI
Proprio, Inc.·00850042604182·Paradigm DRF L-Rod, 150 mm

ReLine

FDA UDI
Nuvasive, Inc.·00195377046987·RELINE-O Trial, 11mm H Lamina W L-pop

Phasix

FDA UDI
Davol Inc.·00801741095290·Phasix ST Mesh, 15 cm (6"), Circle

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193113258·HA PEEK EVOS Straight, ,15mmx8mmx 22mm , FLAT ...

BABY LEXER-STRABISMUS SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896088146·BABY LEXER-STRABISMUS SCISSORS STRAIGHT BLADE P...

Standard Depth Gauge

FDA UDI
Osteocentric Technologies, Inc.·00810074306393·Standard Depth Gauge

BARCOMED 2MP2

FDA 510(k)
FDA Class 2 ·Radiology

IMPLANT GUIDANCE SYSTEM APPLICATOR SET

FDA 510(k)
FDA Class 2 ·Radiology

SMR CONNECTOR SMALL STD

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code KWS·June 28, 2022

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013

SAPIEN XT TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPV·March 13, 2026

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valves

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards Commander Delivery System

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System