BEUDAMED
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    TIE-IN TRAPEZIUM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033529·Baltic Denture System BDLoad BDLoad ↓ Sm6 PLSEu...

    INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET1000, THC

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918000948·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...

    SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POINT 4 TRANSLUCENT MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 3, 2013

    CINCH LEAD ANCHOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code GZB·March 24, 2011

    SUPREME EP CATHETER, 6F, QUADRIPOLAR, JSN

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DRF·April 24, 2008

    BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 26, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 13, 2010

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 7, 2010

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 16, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 23, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 28, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 27, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 17, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 7, 2010

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 10, 2010