BEUDAMED
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    CorTemp

    FDA UDI
    H Q, INC·00857414006049·Lease Handheld electronic device which receives...

    CorTemp

    FDA UDI
    H Q, INC·00857414006018·A small capsule shaped sensor which contains an...

    CorTemp

    FDA UDI
    H Q, INC·00857414006001·A small capsule shaped sensor which contains an...

    CorTemp

    FDA UDI
    H Q, INC·00857414006032·300kHz Handheld electronic device which receive...

    CorTemp

    FDA UDI
    H Q, INC·00857414006025·Handheld electronic device which receives temp...

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·March 27, 2024

    UNK_SMART TOUCH BIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 19, 2024

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 1, 2019

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FON·February 19, 2024

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·May 15, 2026

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 1, 2023

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 19, 2024

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 20, 2024

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·November 16, 2018

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019

    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7MM X 32MM (002-E-27032); n) D 2.7MM X 34MM (002-E-27034); o) D 2.7MM X 36MM (002-E-27036); p) D 2.7MM X 38MM (002-E-27038); q) D 2.7MM X 40MM (002-E-27040)

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022

    Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM X 30MM (002-D-27030); m) D 2.7MM X 32MM (002-D-27032); n) D 2.7MM X 34MM (002-D-27034); o) D 2.7MM X 36MM (002-D-27036); p) D 2.7MM X 38MM (002-D-27038); q) D 2.7MM X 40MM (002-D-27040)

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·August 21, 2025

    SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 23, 2025