58 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
9x15" Medium Utility Positioner with Cover
FDA Recall
Terminated
·Molnlycke Health Care, Inc·Product code OUW·July 26, 2017
7x10" Small Utility Positioner with Cover
FDA Recall
Terminated
·Molnlycke Health Care, Inc·Product code OUW·July 26, 2017
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
.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
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
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
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 6, 2021
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
FDA Enforcement
Class II
·Terminated·Ev3, Inc.·April 30, 2014
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
FDA Recall
Terminated
·Product code DQY·April 9, 2014
Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
FDA Recall
Terminated
·Guidant Endovascular Solutions, Inc.·Product code FGE·August 8, 2005
Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts
FDA Recall
Terminated
·Arrow International Inc·Product code DXE·February 11, 2009
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
FDA Enforcement
Class II
·Terminated·ev3, Inc.·May 4, 2016
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
FDA Recall
Terminated
·ev3, Inc.·Product code LIT·March 29, 2016
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc·December 28, 2016
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
FDA Recall
Terminated
·Medtronic Inc·Product code LIT·November 10, 2016
MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13
FDA Recall
Terminated
·Guidant Corporation ACS·Product code MAF·May 7, 2003
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents
FDA Enforcement
Class I
·Terminated·Vascular Solutions, Inc.·June 28, 2017