14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UASure II Blood Uric Acid Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272422091·Tweed Omega Orthodontic Loop Forming Pliers ARTMAN
LC-DCP
FDA UDI
Synthes GmbH·10886982168290·2.7MM LC-DCP® PLATE 9 HOLES/86MM
Portex
FDA UDI
ICU MEDICAL, INC.·15019517077612·
Pulse oximeter NBM-200
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTROL PLASMA N AND CONTROL PLASMA P
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2025
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·November 19, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 3, 2019
OXF CMNTLS IMPLANT INSERT
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LXH·November 25, 2019
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·Abbott·May 1, 2019