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    MODIFIED VERTIFLEX SPINAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOBELREPLACE CC PMC RP 4.3X10MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021

    NOBELPARALLEL CC NP 3.75X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

    NOBELPARALLEL CC NP 3.75X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

    BENZODIAZEPINES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MILLENNIUM BLADES, MODEL MB101

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 28, 2024

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·April 23, 2013

    SIGNATURE SPRING DRILL PIN

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXH·April 29, 2011

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

    ASR ACETABULAR CUPS 68, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR ACETABULAR CUPS 70, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR 300 Size 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR ACETABULAR CUPS 64, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR ACETABULAR CUPS 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010