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

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    BIOHORIZONS ABUTMENTS FOR ZIMMER

    FDA 510(k)
    FDA Class 2 ·Dental

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383561747·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383503082·Gutta Percha Points is used to root canal filin...

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973288·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970324·

    CERALAS D DIODE LASER SYSTEM, MODEL # D50

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 3, 2022

    OT VERIO TEST STRIPS

    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

    ACHIEVA 1.5T INITIAL SYSTEMS

    FDA Adverse Event
    Injury ·PHILIPS HEALTHCARE·Product code LNH·May 20, 2011

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·September 25, 2014

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·March 11, 2015

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Other ·SURGIQUEST, INC.·Product code HIF·December 12, 2013

    Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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

    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