BEUDAMED
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    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier Scalers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783007282·Implant Scaler Facial (Goldman Fox) 5pk

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105633·PowerChem Neoprene Exam Gloves, Medium

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium

    SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE

    FDA 510(k)
    FDA Class 2 ·Dental

    SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M-H HA/PC 11X160MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    M-H SOLID SHELL HA/PC DIA54MM LN24

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·March 1, 2016

    MALLORY-HEAD SHORT FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·July 28, 2017

    MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·August 11, 2016

    TREATMENT RECLINER

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

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code MIH·March 18, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO B.V.·Product code LWS·June 17, 2008

    MLRY-HD XR LAT POR FMRL 8MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020

    M-H HA/PC 12X165MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    Misys Laboratory System Versions 5.2, 5.23 and 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·January 31, 2003

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; 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