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

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Highlander™ 014 PTA Balloon Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 1, 2012

STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

Sterisystem Dry-Base Instrument Tray

FDA 510(k)
FDA Class 2 ·General Hospital

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 20, 2017

ONE TOUCH BASIC ENHANCED

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·October 16, 2002

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 4, 2008

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·April 19, 2017

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 12, 2015

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·November 4, 2014

SAVVY PTA DILATATION CATHETER

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code LIT·August 25, 2011

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 20, 2013

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

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

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018