BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEXA BONE PLATE AND SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809842302·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE LARGE-...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm

    AT HOME DRUG TEST, MODEL 9079

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CT CORD IQ OPTION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    CORAIL AMT COLLAR SIZE 13

    FDA Adverse Event
    Injury ·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·April 11, 2013

    SCREW INSERTER

    FDA Adverse Event
    Malfunction ·INTEGRA, AKRON·Product code KWQ·March 1, 2011

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·May 23, 2008

    MBT CEM KEEL TIB TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·April 27, 2023

    UNK KNEE FEMORAL SIGMA PS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 27, 2023

    PFC SIGMARP STB TB IN 3 10.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·April 27, 2023

    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·ArthroCare Medical Corporation·December 17, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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