9 results
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13ms
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Sources: EU EUDAMED, US FDA
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
FDA Enforcement
Class I
·Terminated·E25Bio, Inc.·February 16, 2022
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·January 3, 2018
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 13, 2019
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.
FDA Enforcement
Class II
·Terminated·Revmedx Inc·September 23, 2015
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·December 30, 2020
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017