16 results · 32ms · Sources: EU EUDAMED, 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