76 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
FDA Recall
Terminated
·Invision Technologies Inc·Product code ZZZ·October 7, 2005
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
FDA Enforcement
Class II
·Terminated·Ceterix Orthopedics, Inc.·November 18, 2015
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013
Tachos ATx
FDA Recall
Terminated
·Biotronik Inc·Product code LWS·April 29, 2004
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 23, 2013
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 16, 2019
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·February 26, 2020
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
FDA Enforcement
Class II
·Terminated·Ceterix Orthopedics, Inc.·September 5, 2018
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code NEW·August 28, 2019
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code NEW·August 13, 2019
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·June 26, 2019
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
FDA Recall
Terminated
·Ceterix Orthopedics, Inc.·Product code NBH·May 16, 2018
Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
FDA Recall
Terminated
·Ceterix Orthopedics, Inc.·Product code NBH·October 13, 2015
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·March 2, 2016
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 27, 2016
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·March 2, 2016