BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Woven Filiform Straight Tip

    FDA UDI
    C. R. Bard, Inc.·00801741073267·Woven Filiform Straight Tip

    LEANDER, LLC

    FDA registration
    LEANDER, LLC·1 product·🇺🇸 United States

    GYNECOLOGICAL LAPAROSCOPES

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

    KOWA AUTOMATED TONOMETER KT-500

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·July 18, 2019

    EASYPUMP: LT 125-24: 125 ML, 5 ML/HR

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·March 26, 2013

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 15, 2011

    INTERTAN

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code JDS·April 2, 2008

    BD LUER-LOK SYRINGE 60 ML

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 7, 2019

    CHORDX UNKNOWN

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code PAW·January 9, 2024

    BD LUER LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 15, 2019

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·August 21, 2019

    Portex 4 Way ''T-Handle'' Stopcock Catalog Number: T1204

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

    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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022