BEUDAMED
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    BLUE POWDERFREE NITRILE EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Oticon

    FDA UDI
    Oticon A/S·05707131160485·SAFARI 600, BTE 13 P TC

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331127786·grooved director & tongue tie, stainless steel,...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502825·Gutta Percha Points is used to root canal filin...

    SYRINGE 1.0ML 30GA 8MM 10ABAG 500 WAL

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 2, 2020

    REPROCESSED EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PURESPERM 40 AND PURESPERM 80

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DISPERSIVE ELECTRODE (TIN/KATECHO)

    FDA Adverse Event
    Other ·ANGIODYNAMICS, INC.·Product code ODR·October 8, 2008

    STEM: SMS SOLID SMS COLLARED SOLID STEM LAT SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 11, 2022

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 1, 2013

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 23, 2011

    INTERSTIM

    FDA Adverse Event
    Injury ·MPROC, JUNCOS·Product code EZW·August 8, 2008

    LL100 CRYOSURGICAL

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·January 27, 2020

    STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 24, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015