BEUDAMED
    42 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 ×

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Bur PM2-MIS D150 diam C Ø3.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055506327·

    INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 2, 2010

    EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989027099·NI-TI BROAD ARCH UPSML 0180 0250 PK10

    GIGLI SAW BLADE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896047907·GIGLI SAW BLADE

    COOLEY SPOON CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002548·COOLEY PEDIATRIC VASCULAR CLAMP SPOON JAW

    COOLEY SPOON CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921005040·COOLEY PEDIATRIC VASCULAR CLAMP SPOON JAW

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450197127·

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869696036·MOSS MIS XT Rod inserter S 135

    HYBERNITE RAINOUT CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVANTA SUPER SOFT GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING KIT

    FDA Adverse Event
    Malfunction ·SIMS PORTEX·Product code CBT·March 22, 2002

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·May 8, 2013

    ENDOPATH XCEL TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·May 24, 2011

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·August 5, 2008

    32MM DIA COCR MODULAR HEAD -3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·April 22, 2012

    Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 7, 2004

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023

    Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 21, 2013