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

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    ACCELL EVO3 (FORMERLY ACCELL A2I)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHO ARCH

    FDA UDI
    Ortho Arch Company Inc·D90910374214·.017 X .025 RIGHT FORM KEYHOLE 2-LOOP 42MM (10)

    SELF CENTERING

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295003557·SELF CENTERING BI-POLAR HEAD 22.225mm ID 42mm OD

    EXACTECH GPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SORIN C5 SYSTEM WITH MAST ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 16, 2019

    OT VERIO TEST STRIPS

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·September 19, 2014

    MESH- COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·May 17, 2011

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·January 14, 2019

    EQUINOXE

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code KWT·May 31, 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

    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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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

    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

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

    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