87 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.
FDA Recall
Terminated
·ConMed Corporation·Product code DRX·September 23, 2010
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc·Product code HAW·December 22, 2010
BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LIP·November 23, 2010
CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, CELL-DYN 4000 Vent Needle, List Number: 02H61-01, CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
FDA Recall
Terminated
·Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
5440 Patrick Henry Dr
Santa Clara CA 95054-1113·Product code GKZ·July 23, 2010
Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code FYA·December 23, 2010
Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras.
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code FYA·December 23, 2010
QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
FDA Recall
Terminated
·Quidel Corporation·Product code JHI·November 23, 2010
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·August 23, 2010
Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·March 23, 2010
Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
FDA Recall
Terminated
·Maquet Medical Systems, Usa·Product code FQO·April 13, 2012
Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
FDA Recall
Terminated
·Heart Sync, Inc·Product code MLN·December 17, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
FDA Recall
Terminated
·Heart Sync, Inc·Product code MLN·December 17, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010