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

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    MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583033327·ENCHANT 80 MNR FW 3.0

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821899·Buck Ear Curette - #5, Sharp, Straight: 14.5cm

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101087·HELVESTON "BARBIE" RETRACTOR

    ARSENAL PETITE LAPIDUS PLATE, R

    FDA Adverse Event
    Injury ·TRILLIANT SURGICAL·Product code HRS·April 3, 2020

    LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE

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

    BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CERTAIN® GOLD-TITE® HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 10, 2019

    CERTAIN® GOLD-TITE® HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 10, 2019

    BD¿ BLUNT FILL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code GAA·May 1, 2019

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 18, 2019

    RETROX RX 45 - JBP

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO KG·Product code DTB·June 30, 2011

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code MXC·January 11, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    EM ENT STRAIGHT SUCTION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·November 27, 2020

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-35; Shoulder Arthroplasty

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

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025