13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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