BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTAGON Infinity BL RC Burn-out plastic coping for crown, Ø 5.0 mm

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50221171·BL RC Burn-out plastic coping for crown, Ø 5.0 ...

    Safco polycarbonate crowns

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310221173·Safco polycarbonate crowns #102 upper left cent...

    OCTAGON Infinity BL RC Burn-out plastic coping for crown, Ø 5.0 mm

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·XXXX50221179·BL RC Burn-out plastic coping for crown, Ø 5.0 ...

    GC FUJI LINING LC PASTE PAK

    FDA 510(k)
    FDA Class 2 ·Dental

    VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·December 28, 2010

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CDD·August 1, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 26, 2013

    RESTORE PRIME

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 28, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 25, 2008

    SPECTRA OPTIA

    FDA Adverse Event
    Injury ·TERUMO BCT·Product code GKT·August 8, 2022

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    HEPATIC ARTERY INFUSION PUMP

    FDA Adverse Event
    Injury ·INTERA ONCOLOGY·Product code LKK·March 28, 2023

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018