45 results
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19ms
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Sources: EU EUDAMED, US FDA
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
Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm, these units have the same user manual as the HDI4000 system. The different names are used internally as a description for the different configurations of model HDI 4000. Over the product lifecycle, the product configuration changed as follows: MULTIBEAM SYSTEM : This was the original HDI 4000 system branded with the former company name 'ATL' and labeled, "Distributed by ATL Ultrasound Bothell, WA. USA 98041"; PHILIPS 4000 SYSTEM :This configuration changed the legacy 'ATL' brand / colors to the 'Philips' brand / colors; PHILIPS 4000 NEW STANDARD: This Philips brand configuration eliminated hardware that supported the 'CV'. The CV option was initially standard, but later became optional depending on customer preference. The product ID label is the same for both PHILIPS 4000 SYSTEM and PHILIPS 4000 NEW STANDARD. 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
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use.
FDA Recall
Terminated
·Norwex Usa Inc·Product code EFW·February 3, 2015
Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553
FDA Recall
Terminated
·Del Laboratories Inc.·Product code EFW·June 9, 2005
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 3, 2009
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
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·September 28, 2012
Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Small AFW Catalog 23226117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Medium AFW Catalog 23136117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Medium AFW Catalog 23236117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Small AFW Catalog 23126117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018