8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEDIATRIC EUROPHYLIC FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THE CALIFORNIA SPLINT
FDA 510(k)
FDA Class 2
·Cardiovascular
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
CURRENT PLUS DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 24, 2014
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023