BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153152859·INSERT F. BONE GRASPING FORCEPS

    LIPOSUCTION CANNULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0992011940·LIPOSUCTION CANNULA 1X2 TOTEM STYLE

    2.0MM SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036069698·

    TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFR·August 28, 2006

    STERICHEK TOTAL CHLORINE REAGENT STRIPS

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

    RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITAL SIGNS CATHETER MOUNT, DISPOSABLE WITH EXPANDABLE TUBE

    FDA Adverse Event
    Injury ·VYAIRE MEDICAL·Product code CAH·July 29, 2020

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 13, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNQ·July 29, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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