BEUDAMED
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    DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Catalyft PL Expandable Interbody System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000239374·TRIAL 6062116 CATALYFT PL40 11MM

    Universal Precision Composite Instrument #6 (UPC6)

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012836·Dental restorative material applicator

    VESCO

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·20813939024924·16 Fr - Gastrostomy Tube - Dual ENFit Port (Tri...

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707004361·Rumor .018 LR5 -17T 0A 0O

    Gastrostomy Tube - Dual ENFit Port (Tri-Funnel)

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00813939024920·Gastrostomy Tube - Dual ENFit Port (Tri-Funnel)...

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707004378·Rumor .018 LR5 HK -17T 0A 0O

    S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    GORE® PROPATEN® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·March 16, 2021

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 16, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·April 6, 2011

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 18, 2008

    GORE® PROPATEN® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·May 19, 2021

    STERRAD® NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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