8 results
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44ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tian Medical
FDA UDI
Tian Medical, LLC·00864915000308·Tx360™ Nasal Applicator
Tian Medical
FDA UDI
Tian Medical, LLC·00864915000339·Tx360EUTM Nasal Applicator
Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
FDA Recall
Terminated
·Apogee Medical, Inc·Product code GBM·July 17, 2008
Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
FDA Recall
Terminated
·Apogee Medical, Inc·Product code GBM·July 17, 2008
Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
FDA Recall
Terminated
·Apogee Medical, Inc·Product code GBM·July 17, 2008
Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
FDA Recall
Terminated
·Apogee Medical, Inc·Product code GBM·July 17, 2008
Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
FDA Recall
Terminated
·Apogee Medical, Inc·Product code GBM·July 17, 2008
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·June 20, 2012