14 results
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67ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code KNW·February 28, 2017
Neoprobe GDS Control Unit, Model Number NPCU3
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code IZD·September 7, 2020
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code OIJ·May 19, 2016
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code NEU·March 30, 2022
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
FDA Enforcement
Class II
·Terminated·Devicor Medical Products Inc·March 29, 2017
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
FDA Enforcement
Class II
·Terminated·Devicor Medical Products Inc·July 20, 2016
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Enforcement
Class II
·Terminated·Devicor Medical Products Inc·June 1, 2022
Neoprobe GDS Control Unit, Model Number NPCU3
FDA Enforcement
Class III
·Terminated·Devicor Medical Products Inc·October 14, 2020
Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.
FDA Recall
Terminated
·Cardiovascular Systems, Inc.·Product code MCW·April 16, 2009
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code LHI·January 31, 2022
Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXX·May 20, 2011
Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXX·May 20, 2011
Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code FWZ·February 27, 2012
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code JDI·November 7, 2019