30 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code KFM·July 26, 2005
AXIOM Vertix MD Trauma systems radiographic X-ray
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZZ·March 5, 2014
Diagnost 94
FDA Recall
Terminated
·Philips Medical Systems·Product code IZZ·February 20, 2002
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017
Multidiagnost 96
FDA Recall
Terminated
·Philips Medical Systems·Product code IZZ·February 20, 2002
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 1, 2013
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017
AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZZ·August 6, 2018
Diagnost 94
FDA Recall
Terminated
·Philips Medical Systems Sales & Service Region No. America·Product code IZZ·August 10, 2003
Multidiagnost 97
FDA Recall
Terminated
·Philips Medical Systems·Product code IZZ·February 20, 2002
Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·February 13, 2008
Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·January 10, 2008
Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·February 13, 2008
Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI Part Number: 0505-585-000, Lot:11223012 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 30, 2011
Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.
FDA Recall
Terminated
·Biomet, Inc.·Product code JDZ·April 9, 2009
Diagnost 96
FDA Recall
Terminated
·Philips Medical Systems Sales & Service Region No. America·Product code IZZ·August 10, 2003
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017