BEUDAMED
    24 results · 24ms · 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 ×

    Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113745·CCC CYSTOTOME FORMED 27GA

    RESANO BROWN VASCULAR FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084759·RESANO BROWN VASCULAR FORCEPS

    Quala

    FDA UDI
    NATIONAL DISTRIBUTION & CONTRACTING, INC.·D0232003761·Quala Air/Water Syringe Cover 2.5 X 10

    AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    microTargeting™ Frame Adapter

    FDA UDI
    FHC, INC.·00873263003763·CRW Expanding Adapter for use with microTargeti...

    COBRA SURGICAL PROBE

    FDA Adverse Event
    Injury ·EP TECHNOLOGIES, INC.·Product code GEI·May 14, 2004

    NOVAMAX LINK GLUCOSE MONITOR

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 10, 2008

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·July 1, 2013

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 4, 2017

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·March 24, 2017

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014