BEUDAMED
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    RESOLUTE FACET SCREW SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    SafeGuide® Single

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734023303·Disposable Over the Guidewire Esophageal Dilato...

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·04026704094127·PERCUQUICK APPLICATION SET, STERILE

    IN-OVATION® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK

    IN-OVATION® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·April 12, 2021

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 27, 2020

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 20, 2020

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 12, 2020

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 30, 2021

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 5, 2020

    STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M

    FDA 510(k)
    FDA Class 1 ·Dental

    ANTIGEN TESTS FOR RAPID DETECTION OF SARS-COV-2

    FDA Adverse Event
    Malfunction ·UNK·Product code QKP·December 4, 2020

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·May 21, 2013

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    FDA Adverse Event
    Malfunction ·CONVATEC, NIC.·Product code KNT·July 29, 2014

    ENDURON 10D 58 OR 70ODX28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 2, 2011

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    UNKNOWN SMART

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code FGE·December 12, 2017