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

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Laser Treatment System, Model: NYX and Grace

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III

AMPLITUDE

FDA UDI
AMPLITUDE SAS·03701089500821·Resurfacing Patellar Implant NM Cemented Ø 33 mm

24PW - Safety General Purpose

FDA UDI
Certified Safety Manufacturing, Inc.·00766588100333·24PW - Safety General Purpose

Navagio

FDA UDI
Kalitec Direct LLC·B073DRK0100330·Assembly, Navagio Fixed Draw Rod, Large Knob

FEEL-DRCS

FDA 510(k)
FDA Class 2 ·Radiology

LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

SPACEMAKER STRUCTURAL BALLOON TROCAR

FDA Adverse Event
Malfunction ·PONCE-USS·Product code GCJ·October 21, 2008

MP30 INTELLIVUE PATIENT MONITOR

FDA Adverse Event
Injury ·PHILIPS MEDICAL SYSTEMS.·Product code MHX·August 2, 2011

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

INDIGO SYSTEM SEPARATOR 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 7, 2023

V.A.C. FREEDOM THERAPY SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024