155 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Hemospray Endoscopic Hemostat
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·September 25, 2019
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
FDA Recall
Terminated
·Carbon Medical Technologies, Inc.·Product code NEU·December 16, 2022
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code NEU·March 30, 2022
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
FDA Recall
Terminated
·Somatex Medical Technologies GmbH Rheinstr. 7 d Teltow Germany·Product code NEU·May 22, 2017
Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.
FDA Recall
Terminated
·Kapp Surgical Instrument Inc·Product code NEU·May 24, 2011
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
FDA Enforcement
Class II
·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016
GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 29, 2008
OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·April 15, 2008
GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 12, 2008
GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·July 2, 2008
OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·April 15, 2008