75 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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VITROS XT3400 Chemistry System, Product code 6844458
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics·September 2, 2020
VITROS XT7600 Integrated System, Product code 6844461
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics·September 2, 2020
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
FDA Enforcement
Class II
·Terminated·Whirlpool Corporation·August 26, 2020
Burlington Medical, Demi Half Aprons.
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·August 5, 2015
CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·May 1, 2019
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·October 24, 2018
Pulmonary Hemi-Artery SG Used in heart surgery
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·January 29, 2014
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·July 3, 2024
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·May 1, 2024
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·February 24, 2016
Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016