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

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    SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331150951·hohmann retractor, w/ finger ring, 16.0 mm wide...

    ASCENSION SILICONE PIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Brush Biopsy Set ; Deflectable Brush Biopsy Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 18, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·October 20, 2010

    CONICAL SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·December 20, 2012

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·November 15, 2023

    4.5MM BROAD LCP® PLATE 14 HOLES/260MM

    FDA Adverse Event
    Injury ·MONUMENT DEPUY SYNTHES PRODUCTS INC·Product code HRS·October 25, 2022

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·January 7, 2022

    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024