BEUDAMED
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    MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 25, 2014

    ROLLATOR

    FDA Adverse Event
    Other ·MEDLINE INDUSTRIES, INC.·Product code ITJ·January 11, 2013

    MAXIMO II VR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·December 14, 2010

    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

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021