BEUDAMED
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    BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oticon

    FDA UDI
    Oticon A/S·05707131260161·RIA, BTE 13 WL 85 DBL

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331169434·plastic utility scissors, fine pattern, sharp, ...

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK

    NaturaLyte

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861101887·NaturaLyte Liquid Acid Concentrate for Bicarbon...

    Citrasate

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861101382·Citrasate Liquid Acid Concentrate for Bicarbona...

    THE FRIENDLYLIGHT ND: YAG LASERS

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

    DUOCENTRIC REVERSED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·July 2, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·July 2, 2018

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 11, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 21, 2008

    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021

    NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021

    Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021

    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020

    NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020

    Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023