10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583031972·ET40 B 105, 2.4G NFM DPB GR ENCHANT 40
MAMMOSITE II RADIATION THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FRANKENMAN SURGICAL STAPLERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 4, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 26, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 21, 2014
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·August 8, 2024
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 18, 2024
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM 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·St Jude Medical Inc.·July 11, 2018