116 results
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7ms
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Sources: EU EUDAMED, US FDA
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·May 4, 2016
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·March 2, 2016
Ventilator Tubing
FDA Enforcement
Class II
·Terminated·Instrumentation Industries Inc·November 18, 2015
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·August 17, 2016
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
FDA Enforcement
Class II
·Terminated·KCI USA, Inc.·November 28, 2012
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·October 11, 2017
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·July 18, 2012