BEUDAMED
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    EM DEVICE LAB, INC.

    FDA registration
    EM DEVICE LAB, INC.·1 product·🇺🇸 United States

    CHEMOSITE

    FDA Adverse Event
    Injury ·DEVICE LABS, INC.·Product code LJT·August 7, 1996

    CHEMOSITE VENOUS ACCESS SYSTEM

    FDA Adverse Event
    DEVICE LABS, INC.·Product code LJT·January 8, 1995

    CHEMOSITE VENOUS ACCESS SYSTEM

    FDA Adverse Event
    DEVICE LABS, INC.·Product code LJT·January 8, 1995

    CHEMOSITE VENOUS ACCESS SYSTEM

    FDA Adverse Event
    DEVICE LABS, INC.·Product code LJT·January 8, 1996

    Quickloop Abscess Treatment Device

    FDA UDI
    Em Device Lab, Inc·B762M01000010·Device for draining and irrigating cutaneous an...

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·April 20, 2015

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·January 9, 2020

    Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code MNS·October 15, 2007

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·September 4, 2019

    SUREFORM

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GDW·November 15, 2023

    16 SOFT-X

    FDA Adverse Event
    Injury ·SALTER LABS·Product code CAT·August 11, 2023

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DYB·May 19, 2022

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·February 2, 2020

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DYB·September 13, 2022

    CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·December 10, 2019

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·January 16, 2020