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

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KSEA REVERSE VIDEO

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

3M™ Victory Series™

FDA UDI
3M UNITEK CORPORATION·00652221116208·3M™ Victory Series™ First Molar Bands, 952-482,...

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150669·K-WIRE - SINGLE TROCAR THREADED 2.4mm DIA x 200mm

DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER

FDA Adverse Event
Injury ·Product code GCJ·June 20, 2006

ARTELON SURGICAL SUTURE

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

Propeller Sensor Model 2014-R

FDA 510(k)
FDA Class 2 ·Anesthesiology

MAVERICK2 MONORAIL PTCA CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·January 10, 2007

MEDTRONIC.SIGMA

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·February 9, 2013

PALMAZ XL STENT PER 40MM UNMOUNTED

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code FGE·January 7, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2014

BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025