BEUDAMED
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    CATION ADJUSTED MUELLER HINTON BROTH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND

    FDA 510(k)
    FDA Class 1 ·Dental

    ENDOTRACHEAL TUBE 7.5 MM EMG FLEX

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code BTR·July 28, 2010

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013

    ELECTRIC MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 22, 2013

    PATIENT BOX, USED WITH THE LIFE PULSE VENTILA

    FDA Adverse Event
    Other ·BUNNELL, INC.·Product code LSZ·November 5, 2010

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    ENDOTRACH TUBE 8229306J NIM EMG 6MM

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC·Product code ETN·March 6, 2013

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·March 11, 2013

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·August 26, 2013

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·February 11, 2013

    NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·October 18, 2021

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·August 28, 2013

    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10¿ LNR G1 32MM 148-36-52 NV EHXL 10¿ LNR G2 36MM 148-36-53 NV EHXL 10¿ LNR G3 36MM 148-36-54 NV EHXL 10¿ LNR G4 36MM 148-36-55 NV EHXL 10¿ LNR G5 36MM 148-40-53 NV EHXL 10¿ LNR G3 40MM 148-40-54 NV EHXL 10¿ LNR G4 40MM 148-40-55 NV EHXL 10¿ LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·February 19, 2025