38 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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AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 8, 2018
0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- Test System; 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
FDA Recall
Terminated
·Alere San Diego·Product code GJS·February 28, 2011
Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use.
FDA Recall
Terminated
·Therakos, Inc.·Product code LNR·September 1, 2011
Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)
FDA Recall
Terminated
·Therakos Inc·Product code LNR·July 18, 2006
Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
FDA Recall
Terminated
·Therakos Inc·Product code LNR·February 1, 2011
The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
FDA Recall
Terminated
·Therakos Inc·Product code LNR·December 21, 2015
Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
FDA Recall
Terminated
·Therakos Inc·Product code LNR·December 2, 2010
XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient.
FDA Recall
Terminated
·Therakos, Inc.·Product code LNR·March 31, 2011
Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
FDA Recall
Terminated
·Therakos Inc·Product code LNR·March 29, 2010
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
FDA Enforcement
Class III
·Terminated·Medtest Holdings, Inc.·July 5, 2017
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Recall
Terminated
·LDR Spine USA, Inc.·Product code LXH·August 29, 2016
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·October 10, 2012
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
FDA Recall
Terminated
·Medtest Holdings, Inc.·Product code CGS·October 19, 2011
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·November 25, 2015
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Enforcement
Class II
·Terminated·LDR Spine USA, Inc.·October 12, 2016
Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate
FDA Recall
Terminated
·Product code LXH·July 12, 2010
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·January 24, 2018
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code MKJ·July 17, 2017
The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. The RS-FBG is a prescription device for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments. The device is sold individually in several variations for size. It is fitted to the patient and an RS Medical employee gives the patient instructions on how to utilize the device with proper electrode placement in conjunction with the respective TENS/muscle stimulator.
FDA Recall
Terminated
·International Rehabilitative Sciences, Inc.·Product code GXY·May 17, 2010