14 results · 26ms · Sources: EU EUDAMED, US FDA

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MODEL 3000 OPTICATH COMPUTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEONE SPA

FDA UDI
LEONE SPA·08033707030980·WEB 1ST MOL BANDS W/G8325-03 UL 18

Shoreline ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981125189·3.5mm Variable Screw, Self Tapping, 18mm

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·10842209107299·

CENTERPIECE™ Plate Fixation System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902427312·PLATE 853-018 18MM OD

POLY SILOXANE IMPRESSION MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

CELALUX 3

FDA 510(k)
FDA Class 2 ·Dental

MENTOR SMOOTH ROUND MODERATE PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·July 19, 2018

LIBERT CYCLER SET, DUAL PATIENT CONNECT

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 23, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 30, 2012

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 21, 2010

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 15, 2021

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

FDA Enforcement
Class II ·Terminated·STERILMED, INC.·December 16, 2015

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021