7 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·June 15, 2022
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
FDA Recall
Terminated
·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code PPM·February 14, 2022
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
FDA Enforcement
Class III
·Terminated·Cytocell Ltd.·March 30, 2022
WAVES WCM Kidney Cassette Module
FDA Enforcement
Class II
·Terminated·Waters Medical Systems LLC·May 4, 2022
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
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014