BEUDAMED
    134 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

    FDA Enforcement
    Class II ·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024

    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017