34 results
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16ms
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Sources: EU EUDAMED, US FDA
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·August 22, 2018
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
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
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
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