BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    GC ELITE CEMENT 100

    FDA 510(k)
    FDA Class 2 ·Dental

    Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap

    FDA UDI
    Nalge Nunc International Corporation·10850016060485·90ML/53MM SPCW/LBL, NTL CAP,ST

    Sterile Specimen Container

    FDA UDI
    Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.·17503025060085·90ML/53MM SPCW/LBL, NTL CAP,ST

    VANNINI DENTAL INDUSTRY SRL

    FDA registration
    VANNINI DENTAL INDUSTRY SRL·1 product·🇮🇹 Italy

    POLARIS

    FDA UDI
    HNM TOTAL RECON LLC·00841742113401·POLARIS ø4.0mm/ø3.0mm High Compression Screw, C...

    TAPER-LOCK DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    JAS URIC ACID LIQUID REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SCR REPLACEMENT SW-V GOLD COPING

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·October 19, 2017

    SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·December 8, 2020

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·July 12, 2017

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 2, 2017

    PINNACLE 300 ACET CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 26, 2013

    ENTRUST AT

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 16, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 26, 2008

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025