BEUDAMED
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    HVO

    FDA UDI
    H V O·00860007847806·38 1/2" X 48' Non-Woven Opthalmic Drape with Pouch

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·April 10, 2017

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·April 10, 2017

    CPI ENDOTAC LEAD/CPK TRANSVERSE LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC.·Product code LWS·August 30, 1995

    SPIDER RX

    FDA Adverse Event
    Injury ·COVIDIEN·Product code NFA·June 27, 2016

    *

    FDA Adverse Event
    Injury ·*·Product code JXG·September 4, 1996

    MO.MA

    FDA Adverse Event
    Injury ·INVATEC SPA·Product code NTE·June 27, 2016

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 4, 2025

    CRAGG-MCNAMARA

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·May 3, 2022

    RESPONDER 1250

    FDA Adverse Event
    Death ·MARQUETTE ELECTRONICS, INC.·Product code MKJ·July 10, 1997

    JRNY II BCS FEMORAL OXIN RT SZ 5

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·September 9, 2025

    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    1-DAY ACUVUE MOIST

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON VISION CARE, INC. ¿ US·Product code LPL·July 2, 2018

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 21, 2017

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·September 29, 2016

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 15, 2019

    LIFE PAK 10

    FDA Adverse Event
    Malfunction ·PHYSIO CONTROL·Product code DRK·March 18, 1993

    ENDEAVOR RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·April 18, 2018

    ENDEAVOR RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·April 18, 2018