180 results
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10ms
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Sources: EU EUDAMED, US FDA
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 21, 2018
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
FDA Enforcement
Class II
·Terminated·Heraeus Kulzer, LLC.·May 28, 2014
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
FDA Enforcement
Class II
·Terminated·Mckesson Medical Imaging Group·August 29, 2012
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 5, 2016