286 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD DTX Plus, Custom triple-line pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, Custom dual-line pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, Custom single-line pressure monitoting kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, Custom single-line neonatal pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, 12'' single-line neonatal pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, 60'' complete single-line pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, 72'' complete single-line pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, 60'' complete dual-line pressure monitoring kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
BD DTX Plus, Stand-alone pressure transducer with 3cc/hr flush device
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005
DTX(tm) Plus DT-DL60 Continuous flush catheter
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
Tachos ATx
FDA Recall
Terminated
·Biotronik Inc·Product code LWS·April 29, 2004
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 Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013
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
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
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
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
FDA Recall
Terminated
·Pro-Dex Inc·Product code GEY·September 25, 2018
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015