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