32 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·May 16, 2019
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·May 16, 2019
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Y-Type Blood Set, Catalog Number 490530
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Y-Type Blood Set, Catalog Number 490314
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Safeline Y-Type Blood Set, Catalog Number NF5140
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Y-Type Blood Set, Catalog Number 490293
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Y-Type Blood Set, Catalog Number 490425
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Safeline Y-Type Blood Set, Catalog Number V2500
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 20, 2019
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·December 20, 2019
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CHI·December 20, 2019
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
FDA Recall
Terminated
·ulrich medical USA Inc·Product code KWP·December 31, 2019
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
FDA Recall
Terminated
·Biofire Defense·Product code PRD·August 20, 2019
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019