19 results · 30ms · Sources: EU EUDAMED, US FDA

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AIR SONIC SCALER

FDA 510(k)
FDA Class 2 ·Dental

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450292655·

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type

LASER 4SPSC340

FDA 510(k)
FDA Class 2 ·Physical Medicine

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

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

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·March 25, 2015

AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

LINOX SD 65/16

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·April 29, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 10, 2011

NI

FDA Adverse Event
Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·February 19, 2008

EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

BD SAFETYGLIDE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·August 5, 2024

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·November 27, 2014

AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·November 24, 2014

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012