BEUDAMED
    26 results · 20ms · 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 ×

    8 CHANNEL CARDIAC PHASED ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04064279009191·

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10193489206289·ENHANCED ISOLATION KIT XL-XXL

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010030788·4 HOLE FEMALE POST FOR SMALL BONE FIXATOR

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383556200·Gutta Percha Points is used to root canal filin...

    StarBurst

    FDA UDI
    NAVILYST MEDICAL, INC.·H7877001014921·RITA StarBurst Electrosurgical Device

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111337956·MIXING/SOLUTION BOWL 3 QT

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111035429·MIXING/SOLUTION BOWL 3 QT PK12

    IN TEN-S

    FDA 510(k)
    FDA Class 2 ·Dental

    QUINTON Q-STRESS, MODEL 000483

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    DUROM US ACETABULAR COMPONENT 54/48 N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 17, 2011

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number U128, VALITUDE CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number L210 PROPONENT SR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021