54 results
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11ms
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Sources: EU EUDAMED, US FDA
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Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.
FDA Recall
Terminated
·Microgenics Corp·Product code LFW·October 16, 2013
Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LFW·February 10, 2006
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IYN·September 2, 2004
LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IYN·September 2, 2004
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·August 12, 2008
A2613 SPINAL(FL)W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A2654-24 SPINAL (FL) W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·August 22, 2018
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
Juxta-Lite compression wrap XLShort 28cm Length with Separate Small AFW Catalog 23126017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Long 33cm Length with Separate Medium AFW Catalog 23236017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XXL Short 28cm Length with Separate Medium AFW Catalog 23137017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap Medium Short 28cm Length with Separate Small AFW Catalog 23124017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap Large Short 28cm Length with Separate Medium AFW Catalog 23135017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap Medium Short 28cm Length with Separate Medium AFW Catalog 23134017
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010