BEUDAMED
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    TITE FIT

    FDA UDI
    HI-TEC IMPLANTS LTD.·07290110721527·DENTAL IMPLANT

    TITE FIT

    FDA UDI
    HI-TEC IMPLANTS LTD.·07290110721558·DENTAL IMPLANT

    TITE FIT

    FDA UDI
    HI-TEC IMPLANTS LTD.·07290110721534·DENTAL IMPLANT

    TITE FIT

    FDA UDI
    HI-TEC IMPLANTS LTD.·07290110721541·DENTAL IMPLANT

    CATALOG NO. I/A 100 AND KPE 200

    FDA 510(k)

    LIFECARE MODEL 4P PUMP NO I/O

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code FRN·April 26, 1999

    LIFECARE MODEL 4P PUMP NO I/O

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code FRN·November 17, 2000

    LIFECARE MODEL 4P PUMP NO I/O

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code FRN·June 1, 2001

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·October 20, 2015

    ENSEAL G2 ART CURV SEALER 35CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·May 10, 2021

    I-STOP

    FDA Adverse Event
    Injury ·CL MEDICAL·Product code FTL·January 6, 2014

    MENTOR SALINE BREAST IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR·Product code FWM·February 5, 2019

    ENSEAL G2 ART STRA SEALER 35CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·May 22, 2025

    NXSTAGE DIALYSIS TUBING

    FDA Adverse Event
    Malfunction ·NXSTAGE·Product code KDI·October 10, 2016

    I-STOP

    FDA Adverse Event
    Injury ·CL MEDICAL·Product code FTL·January 6, 2014

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM LIGHT ASSEMBLY

    FDA Adverse Event
    Injury ·MALLINKRODT PHARMACEUTICALS·Product code LNR·May 5, 2017

    ENSEAL X1 CURVED 37CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·May 4, 2021

    ENSEAL G2 ART STRA SEALER 35CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·May 22, 2023

    INVACARE MEDICAL

    FDA Adverse Event
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.·Product code IOR·March 18, 2015