BEUDAMED
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    MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large

    ER9W 3GSM AMI

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146ERW3G040·

    Acapella One

    FDA UDI
    Choice Spine, LP·00840996150927·ACAPELLA,TRIAL,PA,NS,12X14X4

    FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 26, 2019

    BD Q-SYTE 15CM SMALL BORE BI-EXT SET

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·January 21, 2025

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    POSITIONPRO WITH PENDANT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNM·April 16, 2013

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·March 18, 2011

    ACCU-CHEK COMPACT PLUS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS CORP.·Product code NBW·June 17, 2008

    ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 14 mm 80 cm .014" REF PMB 4-5-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    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

    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