BEUDAMED
    59 results · 11ms · Sources: EU EUDAMED, US FDA

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    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Enforcement
    Class II ·Terminated·LivaNova USA·May 30, 2018

    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

    FDA Enforcement
    Class II ·Terminated·Remington Medical, Inc.·January 4, 2023

    Dimension Assays: Uric Acid (URCA)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LBS·March 17, 2016

    Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    Advia Chemistry Assay: Lactate

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016

    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JHM·March 17, 2016

    Dimension Assays: Triglycerides (TGL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDT·March 17, 2016

    Dimension Vista Assays: Triglycerides (TRIG)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDT·March 17, 2016

    Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHH·March 17, 2016

    Dimension Vista Assays: Enzymatic Creatine (ECRE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDT·March 17, 2016

    Dimension Vista Assays: Uric Acid (URCA)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    ADVIA CHEMISTRY ENZYMATIC CREATININE_2

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

    Dimension Assays: ENZYMATIC CREATININE

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

    Advia Chemistry Assay: LDL Cholesterol, Direct

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MRR·March 17, 2016

    Dimension Assays: Direct HDL Cholesterol (AHDL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JHM·March 17, 2016

    ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGA·March 17, 2016

    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

    FDA Recall
    Terminated ·Remington Medical, Inc.·Product code KNW·December 2, 2022