BEUDAMED
    15 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 ×

    KENT CAMERA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003075·75 V2 SMALL 22OD ELBOW W/HG

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045166·Paddle Shaver, 15mm

    MEDICAL VISORS MV100

    FDA 510(k)
    FDA Class 2 ·Radiology

    COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH

    FDA 510(k)
    FDA Class 2 ·Neurology

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 12, 2025

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVA

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code MHY·May 15, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·September 24, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2011

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021