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

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    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    e-1 Green 37% Phosphoric acid etchant gel

    FDA UDI
    E DENTAL PRODUCTS·D8912012024·24 pack of 1.2ml Green 37% Phosphoric acid etch...

    e-1 Orange 37% Phosphoric acid etchant gel

    FDA UDI
    E DENTAL PRODUCTS·D8911012024·24 pack of 1.2ml Orange 37% Phosphoric acid etc...

    e-1 Pink 37% Phosphoric acid etchant gel

    FDA UDI
    E DENTAL PRODUCTS·D8913012024·24 pack of 1.2ml Pink Phosphoric acid etchant gel

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 23, 2024

    O2/CO2 NASAL FILTERLINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNKNOWN STRYKER HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·December 28, 2018

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 14, 2011

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRP·March 1, 2024

    Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

    FDA Recall
    Open, Classified ·Btt Health Gmbh Billerberg 7 Inning Germany·Product code BXB·August 1, 2024

    Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·March 1, 2024

    EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    FDA Recall
    Open, Classified ·Trackx Technology Inc·Product code OWB·September 3, 2024