25 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Enforcement
Class II
·Completed·SynCardia Systems LLC·November 1, 2023
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Enforcement
Class II
·Completed·Basic Reset Inc.·November 20, 2019
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Recall
Completed
·SynCardia Systems LLC·Product code LOZ·August 1, 2023
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
FDA Recall
Completed
·Boston Scientific Corporation·Product code LKK·May 11, 2026
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
FDA Recall
Completed
·Bioseal Corporation·Product code KDD·March 23, 2021
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
FDA Recall
Completed
·Bioseal Corporation·Product code KDD·March 23, 2021
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
FDA Recall
Completed
·Bioseal Corporation·Product code KDD·March 23, 2021
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Recall
Completed
·Basic Reset Inc.·Product code N/A·October 18, 2019
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKO·December 22, 2021
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKP·December 22, 2021
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Recall
Completed
·IMMUNDIAGNOSTIK, Inc·Product code DEG·March 27, 2023
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·April 5, 2023
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·April 5, 2023
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
FDA Recall
Completed
·Product code PHX·October 5, 2023
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
FDA Recall
Completed
·Product code PHX·October 5, 2023
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel
FDA Recall
Completed
·International Science & Technology, LP, DBA Diamatrix Ltd.·Product code HNN·February 24, 2022
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·February 22, 2022
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023