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

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    MUELLER HINTON AGAR W/5% SHEEP BLOOD

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Deltaven Fast Flash

    FDA UDI
    DELTA MED SPA·08032248381148·Safety IV catheter in PUR with closed system, d...

    MSI

    FDA UDI
    Modern Surgical Instruments LLC·00810130203000·Micro Discectomy Cervical Curette 8 1/2", bwd s...

    SNAZZY2

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 15, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·November 5, 2007

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    DELTAVEN FAST FLASH

    FDA Adverse Event
    Malfunction ·DELTA MED SPA·Product code FOZ·October 15, 2024

    DELTAVEN FAST FLASH

    FDA Adverse Event
    Malfunction ·DELTA MED SPA·Product code FOZ·October 15, 2024

    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·February 11, 2026