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

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    6PW - CPRotector® TWO Economy - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030005·6PW - CPRotector® TWO Economy - Poly White

    KeyPrint KeySplint Hard

    FDA 510(k)
    FDA Unclassified ·Unknown

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05061075029742·AQUA ULTRA MINI TIE PK1000

    Synchrony (20-3000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tube Set

    FDA UDI
    MECTRA LABS, INC.·00817984011058·Sinus Vacu-Irrigator

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·January 7, 2009

    KENEX

    FDA UDI
    KENEX (ELECTRO-MEDICAL) LIMITED·05055449402798·3001/TC/420/3000 Extuded Track 3m

    HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GRAMS NYLON NONABSORBABLE SUTURE

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

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 13, 2016

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·January 26, 2016

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·October 17, 2008

    SPECTRAFLEX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 23, 2020

    MONSTER SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·PARAGON28, INC·Product code LXH·November 2, 2023

    SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH-03000, KC-03000, SA-03001 and SH-03001. Epidural Anesthesia Kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

    Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 9, 2016

    BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018