BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    HITACHI VERSIFLEX

    FDA 510(k)
    FDA Class 2 ·Radiology

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517676993·Monolith Core, Ø12x31mm

    DAC-CEL T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Andorate Auxiliary Water Connector, Andorate Valves Set

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

    COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·December 22, 2025

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MNH·December 4, 2009

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009

    COLORADO II SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MNH·May 19, 2017

    COLORADO SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·October 17, 2016

    UNKNOWN DEPUY POLY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 6, 2013

    VIVA QUAD XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    COLORADO II SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·July 26, 2011

    ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·September 7, 2022

    Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L

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

    Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K

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

    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, kit number UDIR58AL

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

    Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROBOTIC PACK, kit number BPAR65A; g) HIP PINNING PACK, kit number EMHP84; h) HIP PINNING PK, STRL F G, kit number FHHI17V; i) TOTAL HIP PACK, kit number GNTH06L; j) TOTAL KNEE PACK, kit number GNTK07L; k) EXTREMITY PACK, kit number GUEX48I; l) MAJOR ORTHO PACK, kit number GUMO40J; m) TOTAL KNEE ACCESS PACK, kit number HITK58D; n) SHOULDER ARTHROSCOPY, kit number HNSH17H; o) TOTAL HIP PACK, kit number HNTH76M; p) TOTAL KNEE PACK, kit number HNTK81M; q) ORIF HIP PACK, kit number HOHP28; r) DR. GREENWALD TOTAL KNEE, kit number HSGK80S; s) Custom Lower Ext, kit number JSLE08E; t) HAND PACK, kit number LVHD29; u) KIT, LOWER EXTREMITY, kit number MMEX19E; v) KIT, HIP PINNING, kit number MMHP45E; w) KIT, ORTHO SPINE, kit number MMSP21H; x) KIT, TOTAL HIP, kit number MMTH15E; y) KIT, TOTAL KNEE, kit number MMTK66E; z) KIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E; aa) HIP SCOPE, kit number PTHS10D; bb) HIP SCOPE, kit number PTHS10F; cc) SHOULDER ARTHROSCOPY SAH, kit number SASA18D; dd) SHOULDER ARTHROSCOPY SAH, kit number SASA18F; ee) TOTAL ORTHO SAH, kit number SATO27F; ff) TOTAL ORTHO SAH, kit number SATO27G; gg) PODIATRY PACK, kit number SMPD35; hh) SHOULDER PACK, kit number SMSH12; ii) MAJOR SETUP PACK, kit number SMSU17A; jj) TOTAL HIP, kit number SMTH39; kk) TOTAL KNEE, kit number SMTK21; ll) Knee Arthroscopy, kit number SPKA57Q; mm) SHOULDER ARTHROSCOPY, kit number SPSA58P; nn) Total Hip pack W-O Stryker, kit number SPTH50AF; oo) Total Knee pack W-O Stryker, kit number SPTK51AF; pp) UPPER EXTREMITY, kit number SRUE05M; qq) Arthroscopy Pack, kit number THAR35B; rr) Extremity Pack, kit number THEX27B ss) Shoulder Pack, kit number THSH07F tt) Total Joint, kit number THTJ22G uu) TOTAL HIP PACK, kit number WHTH07D vv) TOTAL HIP PACK, kit number WHTH07E ww) TOTAL KNEE, kit number WHTK06C xx) TOTAL KNEE, kit number WHTK06D yy) CARPAL TUNNEL WEXFORD PACK, kit number WXCT12E

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

    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01

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