BEUDAMED
    17 results · 28ms · 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.

    SPECTACLE PRESCRIPTION LENSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197133·Revision Knee Spiral Reamer- Hudson Short Flute...

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209115457·KIT, FIRST AID - SQUAD ODG - CUSTOM

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981125196·3.5mm Fixed Angle Screw, Self Tapping, 10mm

    Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·April 2, 2014

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 10, 2012

    CAPIOX RX OXYGENATOR W/HARDSHELL RESERVOIR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·September 22, 2010

    TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 2, 2022

    TMJ SYSTEM MEDIUM LEFT FOSSA COMPONENT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 2, 2022

    TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 2, 2022

    Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021