20 results
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18ms
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Sources: EU EUDAMED, US FDA
ID. STORE (RELEASE 2.0)
FDA 510(k)
FDA Class 1
·Radiology
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR
FDA 510(k)
FDA Class 1
·Hematology
DEPUY ASR 300 ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·January 30, 2011
ULTRACISION** HARMONIC SCALPEL** HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 1, 2014
BD FACSCALIBUR FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 20, 2023
BD FACSCALIBUR¿ FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016
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
ASR 300 Size 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 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 68, 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
ASR 300 Size 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 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