223 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·January 27, 2025
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
OxyMask O2 Adult REF OM-1125-14
FDA Recall
Open, Classified
·Southmedic, Inc.·Product code CCK·May 25, 2021
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
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
FDA Recall
Terminated
·ArthroCare Corporation·Product code MBI·September 30, 2010
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA Recall
Open, Classified
·Product code GCJ·February 28, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024