139 results
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21ms
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Sources: EU EUDAMED, US FDA
Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
FDA Recall
Terminated
·Chad Therapeutics Inc·Product code BZD·March 25, 2005
ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011
OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
IMMULITE /IMMULITE 1000 OM-MA (CA125)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014
Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
FDA Recall
Terminated
·Guidant Cardiac Surgery·Product code MWS·December 1, 2006
Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
FDA Recall
Terminated
·Guidant Cardiac Surgery·Product code MWS·December 1, 2006
IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018
ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
FDA Recall
Terminated
·ArthroCare Corporation·Product code MBI·September 30, 2010
OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Recall
Terminated
·ArthroCare Corporation·Product code GAT·February 21, 2019
OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code HWC·August 8, 2011
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code OFA·September 20, 2013
OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
FDA Recall
Terminated
·ArthroCare Corporation·Product code KOG·June 7, 2006
ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
FDA Recall
Terminated
·ArthroCare Corporation·Product code KOG·June 7, 2006
OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
FDA Recall
Terminated
·Stryker Sustainability Solutions·Product code OWQ·March 27, 2020
OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011