46 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Stryker Craniomaxillofacial Division·February 18, 2015
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
.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 Enforcement
Class II
·Terminated·Acumed LLC·March 22, 2017
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
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·March 9, 2022
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·October 21, 2015
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code OQY·January 5, 2015
Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code MFC·June 22, 2009
Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JQW·May 5, 2004
COULTER PrepPlus, Part Number: 286600
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JQW·January 21, 2010
Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
FDA Recall
Terminated
·Tecan U S Inc·Product code JQW·February 27, 2003
Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.
FDA Recall
Terminated
·Hamilton Co·Product code JQW·March 29, 2007
Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle point for use with HPLC injection valves and for sample pipetting) Part #: 87942.
FDA Recall
Terminated
·Hamilton Co·Product code JQW·March 28, 2006
PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via ethernet hub. The computer provides worklist generation, data management, data reduction and microplate reader control functions.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code JQW·September 29, 2009
Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
FDA Recall
Terminated
·Tecan US, Inc.·Product code JQW·September 26, 2014
Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JQW·May 5, 2004
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS
FDA Recall
Terminated
·PerkinElmer, Inc·Product code JQW·October 13, 2016
MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
FDA Recall
Terminated
·Fujirebio Diagnostics, Inc.·Product code OAW·July 29, 2010
Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40 Product is indicated for manual pipetting.
FDA Recall
Terminated
·Hamilton Co·Product code JQW·May 7, 2008