BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MITCHELL DEBAKEY COARCTATION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006180·MITCHELL DEBAKEY COARCTATION CLAMP

    WEITLANER RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048539·WEITLANER RETRACTOR SHARP PRONG TIPS

    MITCHELL DEBAKEY COARCTATION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896011304·MITCHELL DEBAKEY COARCTATION CLAMP

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450810132·

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331167256·brackman suction tube, offset suction tip holes...

    HS Matchstick Burr,Ø3.0x70,80K

    FDA UDI
    Bien-Air Surgery SA·17630055507591·

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005612·Arena-L, Lordotic 10 degrees, 38X28X18

    KING SEPTEMS

    FDA Adverse Event
    Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

    PALOMAR DERMALUX PULSED LIGHT SYSTEM

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

    SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTJ·October 11, 2019

    INFINION CX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 29, 2020

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·May 17, 2011

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024