BEUDAMED
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    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

    FDA 510(k)
    FDA Class 2 ·Immunology

    Citrasate

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861101344·Citrasate Liquid Acid Concentrate for Bicarbona...

    NaturaLyte

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861101696·NaturaLyte Liquid Acid Concentrate for Bicarbon...

    PALABOND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 5, 2023

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·October 17, 2006

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·September 2, 2022

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    GENESIS II

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·May 9, 2011

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·July 24, 2008

    NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·July 20, 2022

    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be 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 ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 21, 2018

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - 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 bottles, Product Code 08-2251-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 bottles, Product Code 08-2251-0 - 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 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·May 31, 2022

    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.

    FDA Enforcement
    Class I ·Terminated·Fresenius Medical Care Holdings, Inc.·July 4, 2012

    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - 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

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - 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