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

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    JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LWS 38 LW RL (1dwt)

    FDA UDI
    ARGEN CORPORATION, THE·D818110626·Gold based noble metal

    ASP

    FDA UDI
    SEDATELEC·03760262490540·The ASP Original, Semi-Permanent Needle, is an ...

    Posted Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90911062613·.016 X.022 POSTED SS RIGHT FORM WIRES 26MM (10)

    POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

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

    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

    BAXANO IO-FLEX SYSTEM

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

    EONC

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

    DIAM 4.3MM SHORT DRILL

    FDA Adverse Event
    Malfunction ·NEWDEAL SAS·Product code HTW·September 16, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

    FARADRIVE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRA·March 12, 2026

    FARADRIVE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRA·March 12, 2026

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024