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

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    GEMENI IGA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Leica Biosystems

    FDA UDI
    Leica Biosystems Richmond, Inc.·20849832023283·PERMASLIDE, White Non-clipped

    0800,APS0,08,RD,RM,SP,SN,RDL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828147675·0800,APS0,08,RD,RM,SP,SN,RDL

    SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MINXRAY MODEL CMDR-2S

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTRA-AORTIC BALLOON CATHETER

    FDA Adverse Event
    Injury ·DATASCOPE CORP.·Product code DSP·April 27, 1998

    BIODESIGN URETHRAL SLING

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code PAG·April 3, 2014

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 22, 2012

    PFC CVD TB INS, SZ4, 10.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 12, 2010

    SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·September 29, 2008

    SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·September 29, 2008

    Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code FRN·March 24, 2021

    Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HFM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HFM·September 19, 2019

    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