BEUDAMED
    21 results · 26ms · Sources: EU EUDAMED, US FDA

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    IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    artegral life HD

    FDA UDI
    Merz Dental GmbH·D7092004013·artegral life HighDefinition posterior lower -M...

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105628·HA PEEK EVOS Straight, ,13mmx9mmx 26mm , FLAT ...

    Baby Gorilla/Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795023384·P28, Schanz Pin, Ø4.0mm, AO Connect, SS

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20040130·2.0mm Cortex Screw, 1.5 Hex, Self-Tapping, 13mm

    MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CADD PRIZM VIP PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·December 19, 2018

    GEMSTR 7 THPY ALT ST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 28, 2014

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·March 7, 2013

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014

    DLT TS CER HD 12/14 36MM +12

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·March 14, 2013

    BAUSCH & LOMB SOFLEX IOL

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·February 22, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 26, 2008

    THERASPHERE

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LTD·Product code NAW·May 15, 2017

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·March 7, 2013

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·March 7, 2013

    POWER CORD, TGS SYSTEM V2, 20' LG

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 22, 2019

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025