BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    UNICEM HM

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00856402006115·Decan Stopper Size 4 Closure 1/4

    CASTENADA CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921009080·CASTENADA CLAMP MEDIUM DOUBLE CURVED JAW ANGLED...

    CASTENADA CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896003897·CASTENADA CLAMP MEDIUM DOUBLE CURVED JAW ANGLED...

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857527904·AN Lordotic Spreader Size 8.5x28x5 mm, 6°

    COALESCE

    FDA UDI
    VERTERA, INC.·B1422000001009080·10x28x9MM COALESCE-Straight, Lordotic

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327102208·Posterior Stabilized Tibial Insert

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·00612479241916·Therapy Putty firm resistance level 4 oz

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    SKYLIGHT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDICON TITANIUM YASARGIL ANEURYSM CLIPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    VIPER WIRE ADVANCE

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS, INC·Product code MCW·May 18, 2011

    BD DIRECTIGEN MENINGITIS COMBO TEST KIT

    FDA Adverse Event
    Injury ·BD DIAGNOSTICS·Product code GTJ·August 7, 2008

    DREAMSTATION GO AUTO

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·May 31, 2024

    UNK - IMPLANT

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code MAI·August 15, 2024

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025