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

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    LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OptiBite Disposable Biopsy Forceps

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503540353·Normal handle, Alligator, with spike, Single o...

    Complete Needle

    FDA UDI
    SHARPS COMPLIANCE CORP.·00634188001889·1-Quart Sharps Container - Complete Needle

    CSU BLUMENTHAL RONGEUR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896081567·CSU BLUMENTHAL RONGEUR

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450525791·

    HS Diam. Burr, Ø3.1x95, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507164·

    Zavation

    FDA UDI
    Zavation LLC·00842166176461·7.5 mm Cannulated Tap

    Zavation

    FDA UDI
    Zavation LLC·00842166175815·7.5mm Tap

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·May 24, 2018

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 24, 2015

    REPLY 200

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NVZ·September 19, 2014

    TERUMO ADVANCED PERFUSION SYSTEM I

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·May 13, 2011

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023

    HF-RESECTION ELECTRODE, LOOP

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023

    MICROCLAVE CLEAR CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

    FDA Enforcement
    Class I ·Terminated·Cardiovascular Systems, Inc.·August 20, 2014