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

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    Momentum Spine

    FDA 510(k)
    FDA Unclassified ·Unknown

    RIGIDLOOP

    FDA UDI
    Medos International Sàrl·10886705022731·RIGIDLOOP Cortical Fixation Implant 60mm

    Capo Hybrid A 4, 5 g

    FDA UDI
    Schütz Dental GmbH·ESDG2320231·Capo Hybrid is a light-curing hybrid composite ...

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369535·HEEL REST LARGE

    Virage Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    W.O.M. LASER U100PLUS

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

    MECTALIF ANT - LAG

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

    8/23/2023

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·October 4, 2023

    DREAMSTATION AUTO BIPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 8, 2022

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 1, 2011

    LS PLUMSET-OL DUAL W/CLAVE & 0.2MICRON FILTER

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPA·August 28, 2008

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 17, 2013

    NEEDLE 23G 1-1/4IN TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·August 9, 2019

    regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48

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

    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;

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

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

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

    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·May 23, 2023

    MINISCAV (tm) Vacuum Pump

    FDA Recall
    Open, Classified ·R A Medical Services Holmes House Skipton Road Keighley United Kingdom·Product code BTA·August 23, 2023

    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack, kit number RBCS12R; g) C-Section, kit number THCS49B; h) C-SECTION PACK (PS 020632), kit number UICS50AG;

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