938 results
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14ms
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Sources: EU EUDAMED, US FDA
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code FTL·December 17, 2014
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code FTM·December 29, 2021
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
FDA Recall
Terminated
·Acumed LLC·Product code LXH·February 17, 2017
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
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
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
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