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

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    ENEO TOTALE (Model: ENEOT947)

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

    Ophthalmic Hooks

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114315·PUSH-PULL HOOK ANGLED (BX/3)

    3DFIS, MODEL IES-FL-101

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMUNOCAP ALLERGEN COMPONENTS BUNDLE

    FDA 510(k)
    FDA Class 2 ·Immunology

    FLAT TITANIUM PECTUS BAR 10.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 12

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 22, 2008

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·August 4, 2011

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 9, 2013

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    TPRLC 133 MP TYPE1 BM SO 14.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 25, 2023

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 12.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017