BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    PRO-LITE Sterilization Tray

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304270985·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304473058·

    N/A

    FDA UDI
    Ortho Development Corporation·00822409131419·Asymmetric Tibial Tray Sizing Template Size 2

    AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECSYS DHEA-S CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SERIES A PATELLA PEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018

    BIOMET I-BEAM STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018

    BIOMET MAXIM PRIMARY TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBV·August 9, 2018

    UNKNOWN VANGUARD PATELLA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018

    NEOCIS GUIDANCE SYSTEM

    FDA Adverse Event
    Injury ·NEOCIS INC.·Product code PLV·September 13, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    INTERJECT¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FCG·July 28, 2011

    TRIMA ACCEL

    FDA Adverse Event
    TERUMO BCT·Product code GKT·June 22, 2013

    VANGUARD FEMORAL LEFT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018

    VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT 55MM RIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 24, 2022

    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.

    FDA Recall
    Open, Classified ·Nalu Medical, Inc.·Product code GZF·June 3, 2024

    Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205

    FDA Enforcement
    Class II ·Ongoing·Illumina, Inc.·December 10, 2025

    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017