589 results
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17ms
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Sources: EU EUDAMED, US FDA
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Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Recall
Completed
·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.
FDA Recall
Terminated
·PF Consumer Healthcare 1 LLC·Product code IMD·April 26, 2019
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
FDA Recall
Open, Classified
·Hamilton Medical, Inc.·Product code CBK·July 26, 2023
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.
FDA Recall
Terminated
·PF Consumer Healthcare 1 LLC·Product code IMD·April 26, 2019
VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics, INc.·Product code N/A·March 26, 2021
Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·April 10, 2008
RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
FDA Recall
Terminated
·Rita Medical Systems·Product code GEI·October 6, 2003
Computed Tomography, Models TSX-101A and TSX-021A.
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code JAK·March 17, 2004
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·December 11, 2019
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·December 11, 2019
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·December 11, 2019
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·March 7, 2019
Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
FDA Recall
Terminated
·Straumann USA LLC·Product code OAT·September 28, 2007
Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
FDA Recall
Terminated
·Straumann USA LLC·Product code OAT·September 28, 2007