446 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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Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007
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
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 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 Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·September 29, 2017
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
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 Recall
Terminated
·Heraeus Kulzer, LLC.·Product code LBH·April 23, 2014
Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 737 (also known as Model ST104). Wheeled hospital stretcher.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009
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
Coulter LH500 Series System The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·January 31, 2011