BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONNECTOR 22M - 22F WITH MDI INSERT

    FDA UDI
    Intersurgical Incorporated·05030267057412·CONNECTOR 22M - 22F WITH MDI INSERT

    Acrometrix HIV-1 Low Control

    FDA UDI
    Microgenics Corporation·00884883006478·

    SeaSpine NewPort Spinal System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981125752·Newport Extension Tray

    Orthopedic Cannulated Nail Instrument Pack 3.0 x 50mm

    FDA UDI
    Eca Medical Instruments·00857676008577·

    TARGET THERAPEUTICS RADIOPAQUE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMERGENCY RESPONSE SAFETY KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRULIANT TIB IMP PSC INSERT SZ 3.5, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 11, 2024

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INC.·Product code BTO·May 22, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 15, 2013

    POLIGRIP

    FDA Adverse Event
    Injury ·GLAXOSMITHKLINE·Product code KOL·January 12, 2011

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021