BEUDAMED
    35 results · 21ms · 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 ×

    Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

    FDA 510(k)
    FDA Class 2 ·Immunology

    BALANCE MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304446427·

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481122651·LOCATOR R-Tx Attachment System for 2.9mm Platfo...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776187590·Probe with eye, stainless, .

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481122477·LOCATOR F-Tx Abutment for 2.9mm Platform Conica...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034081·Profile Zero 4 Hole Straight Plate, Long

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379584·Integra® Jarit® Probe With Eye, 5-1/2"

    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15

    FDA Enforcement
    Class II ·Terminated·TriMed Inc.·June 27, 2018

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694065641·Profile 0 4 Hole Long Straight Plate Sterile Qty 5

    ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

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

    SLIT LAMP BO 900, BQ 900, BP900

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

    FDA Adverse Event
    Malfunction ·MEDIVANCE -1725056·Product code DWJ·April 16, 2025

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 3, 2021

    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    FDA Enforcement
    Class II ·Ongoing·Medivance Inc.·April 3, 2024

    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    FDA Recall
    Open, Classified ·Medivance Inc.·Product code DWJ·February 16, 2024

    PALINDROME HSI KIT 23/40 CM X5.

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·June 4, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code MMI·July 27, 2011

    AURIA

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·September 29, 2008

    ELECTROSURGICAL GENERATOR "ESG-300"

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 29, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·August 20, 2021