BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    ACE TRIMARK TRICAM DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    KEYHOLE 2-LOOP ARCHWIRE KIT

    FDA UDI
    Ortho Arch Company Inc·D90910379017·.017 X .025 RIGHT FORM KEYHOLE 2-LOOP KIT (75)

    DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CALCIGEN-S BONE VOID FILER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022

    OT PING METER

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    LSLF EXT SET W CLV

    FDA Adverse Event
    Injury ·HOSPIRA LTD.·Product code FPK·May 24, 2011

    INSTINCT ENDOSCOPIC HEMOCLIP

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code MND·June 13, 2013

    GALAXY G3 6MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    GALAXY G3 XSFT 3MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    GALAXY G3 4MM X 12CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    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

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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

    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