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rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Enforcement
Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red. )

FDA Recall
Terminated ·Product code MMK·February 25, 2004

smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

FDA Recall
Terminated ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·June 10, 2020

medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

ADVIA Chemistry Calibrator

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NDW·June 5, 2020

Atellica CH Chemistry Calibrator

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGX·June 5, 2020

Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.

FDA Recall
Terminated ·NuVasive Inc·Product code PDQ·June 10, 2020

TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

FDA Recall
Terminated ·Accuray Incorporated·Product code IYE·December 10, 2020

TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

FDA Recall
Terminated ·Accuray Incorporated·Product code IYE·December 10, 2020