116 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Tachos ATx
FDA Recall
Terminated
·Biotronik Inc·Product code LWS·April 29, 2004
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
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
FDA Enforcement
Class II
·Terminated·NOX MEDICAL·October 13, 2021
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: TX Stapler, Reloadable, Linear 30 mm and 60 mm, item numbers TX30 and TX60
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·February 26, 2020
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 16, 2019
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
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
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 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 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
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
FDA Recall
Terminated
·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021
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
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·October 25, 2017
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
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
FDA Recall
Terminated
·Medisystems a NX Stage Company·Product code FIE·December 20, 2012
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
FDA Recall
Terminated
·Medisystems a NX Stage Company·Product code FIE·December 20, 2012
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·April 24, 2013
B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·July 24, 2013
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
FDA Enforcement
Class II
·Terminated·Medisystems a NX Stage Company·January 30, 2013