119 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·June 20, 2012
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code IZL·October 19, 2011
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
FDA Recall
Terminated
·Eizo Corporation 153 Shimokashiwano Hakusanshi Japan·Product code PGY·July 7, 2015
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
FDA Recall
Terminated
·Eizo Corporation 153 Shimokashiwano Hakusanshi Japan·Product code PGY·July 7, 2015
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
FDA Recall
Terminated
·DiaSorin Molecular LLC·Product code PGI·May 12, 2020
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
FDA Recall
Terminated
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code PGY·January 22, 2021
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
FDA Recall
Terminated
·Eizo Corporation 153 Shimokashiwano Hakusanshi Japan·Product code PGY·July 7, 2015
Multitom RAX with software version VF10
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021
Multitom RAX with software version VF10
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021
AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
FDA Recall
Terminated
·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009
AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
FDA Recall
Terminated
·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009
Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·March 14, 2018
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
FDA Enforcement
Class II
·Terminated·Southern Implants, (Pty.) Ltd.·April 25, 2018
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·February 20, 2019
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·February 20, 2019
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020