BEUDAMED
    19 results · 21ms · 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 ×

    Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464093663·SONIC ENCHANT SE 10 MNR T DG

    Cortina

    FDA UDI
    NEUROSTRUCTURES, INC·00841508104490·PLIF Cage, Non-Lordotic 25mm x9mm x07mm

    PLIF Cage

    FDA UDI
    Eisertech, LLC·B523100149250907·Non-Lordotic TPLIF Cage, Titanium 25AP X 09ML X...

    Cortina

    FDA UDI
    NEUROSTRUCTURES, INC·00841508104810·BN PLIF Cage, 4 Deg-Lordotic 25mmx9mmx7mm

    PLIF Cage

    FDA UDI
    Eisertech, LLC·B523100035250907·PLIF CAGE, NON-LORDOTIC, 25AP X 09ML X 07HT

    PLIF Cage

    FDA UDI
    Eisertech, LLC·B523100198250907·Lordotic Bullet Nose Cage, 25AP X 09ML X 07HT

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522509070·

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00810065990365·Squadron Anatomical Bullet Nose PLIF Cage, 25mm...

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00811771037283·Squadron Lordotic Bullet Nose PLIF Cage, 25mm x...

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00811771035487·Squadron Parallel Bullet Nose PLIF Cage, 25mm x...

    FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

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

    SILVERGLIDE

    FDA UDI
    STRYKER CORPORATION·04546540714978·Non-Stick Bipolar Electrosurgical Forceps SK Ba...

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·December 2, 2008

    INFUSION PUMP

    FDA Adverse Event
    Malfunction ·SIGMA·Product code FRN·August 29, 2011

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 29, 2013

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020