13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
2 VELCRO SPLINT STRAP
FDA 510(k)
FDA Class 1
·Physical Medicine
CoRoent
FDA UDI
Nuvasive, Inc.·00887517361295·CoRoent SI Inserter, Freehand
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515204348·Waldsachs Forceps, 6"
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
FDA 510(k)
FDA Class 2
·Radiology
Unity Subcutaneous Delivery System for Remodulin
FDA 510(k)
FDA Class 2
·General Hospital
RENALIN PR TEST SYSTEM PACKET
FDA Adverse Event
Malfunction
·MINNTECH/MEDIVATOR·Product code LIF·April 18, 2017
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
SCORPIO TS TIB INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·August 3, 2010
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
BD ALARIS¿ SECONDARY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023
UNSPECIFIED BD ALARIS¿ INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025