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

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    MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950022960·SUCTION TIP FRAZIER 30 DEGREE ANGLE SIZE 9 FREN...

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099144·DB BKT MASTER HGW LL 1ST BIC 018 T-17 A=0 R4D

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746096525·DB BKT MASTER IBD UR LAT 018 T+7 A+9 R=0

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2019

    HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MERETE LOCKING BONE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 27, 2014

    1.6MM WIRE GUIDE FOR 3.7MM CANNULATED LOCKING SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code DQX·January 7, 2013

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 8, 2010

    Wound Closure Tray I, catalog# 900-063

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·December 8, 2011

    Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCY·January 7, 2016

    Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCY·October 8, 2014

    WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019

    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