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

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    ZEST PETITE NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SUPRA

    FDA UDI
    BLV Licht- und Vakuumtechnik GmbH·B5331037860·

    B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 15, 2014

    B LOCUS HIGH RES SP UNITRAY KIT

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORP·Product code MZI·January 15, 2014

    B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 15, 2014

    DRG ORTHOHEX SS BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMF RESORBABLE MESHES AND SHEETS

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    AIR OPTIX FOR ASTIGMATISM

    FDA Adverse Event
    Injury ·PT. CIBA VISION BATAM·Product code LPM·May 24, 2011

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 26, 2026

    UNK HIP FEMORAL STEM REEF DISTAL STEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code LPH·September 16, 2025

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 16, 2025

    UNKNOWN HIP FEMORAL CONSTRUCT REEF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·September 16, 2025

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    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

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    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

    GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025