89 results
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23ms
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Sources: EU EUDAMED, US FDA
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Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), MEVATRON M 7445 (MXE), MEVATRON M 7400/7440 (MXE), MEVATRON M 6730/6740 (MXE), MEVATRON M 6700 (MX): the intended use of the MEVATRON , PRIMUS , ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 2, 2014
Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 1, 2011
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
FDA Recall
Terminated
·ASO, LLC·Product code MXE·August 21, 2013
Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
FDA Recall
Open, Classified
·Rebiscan, Inc.·Product code PMW·October 3, 2022
Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.
FDA Recall
Terminated
·Bock, Otto, Orthopedic Ind, Inc Two Carlson·Product code ISY·October 28, 2008
Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·December 1, 2010
ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
FDA Recall
Terminated
·Northwest Medical Physics Equipment Inc·Product code IYE·April 7, 2006
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
FDA Recall
Terminated
·Elekta, Inc.·Product code IYE·April 30, 2013
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Completed
·Accuray Incorporated·Product code IYE·December 23, 2024
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·April 14, 2011
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. Made in USA
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·July 27, 2012
Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·July 27, 2012
Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Recall
Terminated
·Elekta, Inc.·Product code IYE·March 28, 2013