BEUDAMED
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    REPROCESSED COMPRESSION SLEEVES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pro-Flo XT™

    FDA UDI
    MEDTRONIC, INC.·00613994944580·CATH 060049 PF 10PK6F XT PIG 145D 125

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450052785·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600090·Tray Insert, Level II

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600090·Tray Insert, Lumbar Instruments, 1

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600090·Tray Insert, Disc Prep 2

    8" EXT. SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·April 15, 2016

    PULSECO HEMODYNAMIC MONITOR CM71

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUNI MAX

    FDA 510(k)
    FDA Class 1 ·Dental

    R SEREIS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER MINUS 6MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 15, 2011

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·June 12, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

    NON-VENTED HOSPITAL FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017

    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

    FDA Enforcement
    Class III ·Terminated·Diagnostic Hybrids Inc·February 13, 2013

    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

    FDA Recall
    Terminated ·Diagnostic Hybrids Inc·Product code LKA·December 31, 2012

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018