16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
FDA 510(k)
FDA Class 2
·Immunology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450181164·
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·February 8, 2012
NAVIGATION PROBES
FDA 510(k)
FDA Class 2
·Neurology
MICRO-MAX, MODEL 319
FDA 510(k)
FDA Class 2
·Radiology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 27, 2015
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2014
BIOARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 19, 2012
ALLURA XPER FD20
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code IZI·August 11, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 14, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 2, 2015
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 8, 2017
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 20, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 21, 2013
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024