BEUDAMED
    21 results · 25ms · 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 ×

    PILAIRO NASAL PILLOWS MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Chemosite

    FDA UDI
    Covidien LP·10884521099388·Low Profile Venous Access System

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707008897·CALIBRA 1ST MOLAR BANDS n.UR 27

    PharmaTags

    FDA UDI
    RMAC Surgical, Inc·00754027700923·5 sterile custom medication labels

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450048658·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197027113·Deaver Operating Scissors Fig. 1 curved...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197027083·Deaver Operating Scissors Fig. 1 curved...

    AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    FOCUS RADIATION TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·February 8, 2019

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 25, 2014

    RENAISSANCE 29 P-WASHOBS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 26, 2011

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·January 30, 2018

    HANG&GO HT BASIC

    FDA Adverse Event
    Malfunction ·RAND S.R.L.·Product code LGZ·May 15, 2017

    RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·December 24, 2014

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    EMBLEM S-ICD Model A209

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