BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    EPR-200 PROGRAMMER MODEL 010

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ACUMED

    FDA UDI
    Acumed LLC·10806378041662·Trial Lkg RH Tray Insert Base

    ONCOBIONIC SYSTEM

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

    SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code OAB·June 9, 2015

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 8, 2014

    PEDICLE SCREW

    FDA Adverse Event
    Injury ·OMNI SURGICAL SPINE 360·Product code NKB·October 22, 2012

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 28, 2007

    MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S

    FDA Recall
    Terminated ·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019

    JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

    FDA Recall
    Open, Classified ·JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No·Product code CAW·December 9, 2024

    MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S

    FDA Recall
    Terminated ·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019

    MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S

    FDA Recall
    Terminated ·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019

    MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S

    FDA Recall
    Terminated ·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019

    MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S

    FDA Recall
    Terminated ·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019

    MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

    FDA Recall
    Terminated ·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019

    Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)

    FDA Recall
    Terminated ·Roscoe Medical Inc·Product code ITJ·October 1, 2014

    E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code OAH·June 8, 2010

    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.

    FDA Recall
    Terminated ·Compass Health Brands·Product code CAF·April 20, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021