BEUDAMED
    18 results · 22ms · 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 ×

    ADVIA Centaur® NT-proBNPII (PBNPII)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ambIT* Remote Bolus Switch

    FDA UDI
    Avanos Medical, Inc.·00193494000776·Remote Bolus Switch

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator

    TempoLok NE Cement 2x5ml syringe, 20 mixing tips

    FDA UDI
    STERNGOLD DENTAL LLC·00841549100468·Temporary cement for attaching all kinds of tem...

    Ochsner Aorta Clamp 23.5cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034053867·Ochsner Aorta Clamp 23.5cm

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361035916·FENESTRATED SCREW, CANNULATED, Ø12MM x 65MM, SA...

    SERRALENE, MODEL CATALOG NO 1S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Surgical Drills

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 14, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 25, 2023

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 5, 2020

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HXX·October 31, 2008

    60-CM LENGTH PENTA LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 16, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    SURGITEK GEL/SALINE INFLATABLE BREAST IMPLANT, 220/265 CC

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·June 7, 1994

    CLIN CHEM LDH

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CFJ·February 12, 2018

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024