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

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    Dermatological Diode Laser Systems

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

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)

    VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100

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

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·August 31, 2022

    202257-000 Needle, Mono Kit Ambu CA CE

    FDA UDI
    Ambu A/S·05707480109715·Cadwell Neuroline Monopolar Kit

    VULCAN GENERATOR

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE·Product code GEI·October 29, 2010

    ALTIS SINGLE INCISION SLING SYSTEM

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code PAH·December 20, 2022

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    PLV-102

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·June 28, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 5, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021