16 results · 21ms · Sources: EU EUDAMED, US FDA

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Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron

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

Oticon

FDA UDI
Oticon A/S·05707131280336·NERA2 PRO, BTE 13 WL 85 CBE DEMO

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

CT/MR M.A.C. Interstitial GYN Template, 17G

FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024251·

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC

FDA 510(k)
FDA Class 2 ·Ophthalmic

MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

FDA Adverse Event
Injury ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code HSB·August 3, 2018

PRECISION MONTAGE MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2020

MISAGO RX Self Expanding Peripheral Stem

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 7, 2016

MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

FDA Adverse Event
Injury ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 5, 2019

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·June 6, 2013

ELECTRIC DERMATOME HANDPIECE

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·June 22, 2011

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 27, 2025

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Philips Zenition 70, Model Number: 718133

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024