13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tablo® Hemodialysis System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Kitazato ET Catheter
FDA UDI
KITAZATO CORPORATION·04580745042214·
6233335
FDA Adverse Event
Malfunction
·January 9, 2017
POWERPORT IMPLANTABLE PORT
FDA 510(k)
FDA Class 2
·General Hospital
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 18, 2013
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 29, 2019
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·January 14, 2020
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·December 27, 2019
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026