BEUDAMED
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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM

    Ignite Stemless Anatomic Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113769·AIR INJECT CANNULA 30GA

    GEO 1st MTP Joint Arthrodesis Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Enforcement
    Class II ·Terminated·Anodyne Surgical·June 23, 2021

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 27, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    ULTRAFLEX? ESOPHAGEAL NG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code ESW·July 2, 2013

    OASYS

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code LRK·April 28, 2022

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Recall
    Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 26, 2018

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    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