16 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS ALKALINE PHOSPHATASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIO MEDX AIR FLOTATION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
I-125 SEEDS CODE: 6702
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 20, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 22, 2013
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
ASR UNI FEMORAL IMPL SIZE 43, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 45, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 39, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 53, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 55, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 49, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 51, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 47, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR UNI FEMORAL IMPL SIZE 41, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm 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 taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010