142 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 2, 2016
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
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
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
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 22, 2021
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 22, 2021
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
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
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018