11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
FDA 510(k)
FDA Class 2
·Radiology
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
JUVEDERM ULTRA PLUS
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·April 3, 2013
UNKNOWN DEPUY FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·May 7, 2008
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 5, 2011
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 5, 2025
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code FMT·April 21, 2010
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013