B06 STRESS RESISTANCE (avena sativa, chamomilla, cherry plum, clematis vitalba, coffea cruda, english oak, eschscholtzia californica, european hornbeam, ficus carica, humulus lupulus, ignatia amara, impatiens glandulifera, kali phosphoricum, kali silicatum, melissa officinalis, passiflora incarnata, phosphoricum acidum, pyrenees star of bethlehem, rockrose, sus scrofa parasympathetic nerve, pineal gland, sympathetic nerve, valeriana officinalis, verbena officinalis, zincum valerianicum) solution/ drops [Apex Energetics Inc.]
Updated Date: Wed, 10 Jan 2024 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 10, 2024 Category: Drugs & Pharmacology Source Type: alerts

GUNA-STOMACH (activated charcoal - antimony trisulfide - bismuth subnitrate - dioscorea villosa root - dopamine - human epidermal growth factor - ipecac - oregano - picea mariana resin - robinia pseudoacacia bark - semecarpus anacardium juice - silver nitrate - sus scrofa stomach - sus scrofa sympathetic nerve - momordica balsamina immature fruit -) pellet [Guna spa]
Updated Date: Wed, 16 Nov 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 16, 2022 Category: Drugs & Pharmacology Source Type: alerts

B06 STRESS RESISTANCE (avena sativa, chamomilla, cherry plum, clematis vitalba, coffea cruda, english oak, eschscholtzia californica, european hornbeam, ficus carica, humulus lupulus, ignatia amara, impatiens glandulifera, kali phosphoricum, kali silicatum, melissa officinalis, passiflora incarnata, phosphoricum acidum, pyrenees star of bethlehem, rockrose, sus scrofa parasympathetic nerve, pineal gland, sympathetic nerve, valeriana officinalis, verbena officinalis, zincum valerianicum) solution/ drops [Apex Energetics Inc.]
Updated Date: Wed, 24 Mar 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 24, 2021 Category: Drugs & Pharmacology Source Type: alerts

VIATREXX-PROLO-NEURAL (adrenal, bdnf, beta endorphin, coelliac plexus, nerve, pituitary gland, sympathetic trunk) spray [VIATREXX BIO INCORPORATED]
Updated Date: Mon, 25 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 25, 2021 Category: Drugs & Pharmacology Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Atellica CH Creatine Kinase (CK_L) - Class 2 Recall
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - ADVIA Chemistry Creatine Kinase (CK_L) - Class 2 Recall
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts

GUNA-SPASM (Atropine Sulfate - Berberis Vulgaris Root Bark - Chelidonium Majus - Cobalt - Cultivated Mushroom - Gelsemium Sempervirens Root - Interleukin-10 - Magnesium - Melatonin - Metenkefalin - Sus Scrofa Sympathetic Nerve - Sus Scrofa Vagus Nerve - Watermelon - Anti-Interleukin-1.Alpha. Immunoglobulin G Rabbit -) Solution/ Drops [Guna Spa]
Updated Date: Jan 3, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 3, 2019 Category: Drugs & Pharmacology Source Type: alerts

GUNA-STOMACH (Activated Charcoal - Antimony Trisulfide - Bismuth Subnitrate - Dioscorea Villosa Root - Dopamine - Human Epidermal Growth Factor - Ipecac - Oregano - Picea Mariana Resin - Robinia Pseudoacacia Bark - Semecarpus Anacardium Juice - Silver Nitrate - Sus Scrofa Stomach - Sus Scrofa Sympathetic Nerve - Momordica Balsamina Immature Fruit -) Pellet [Guna Spa]
Updated Date: Dec 24, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 24, 2018 Category: Drugs & Pharmacology Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Faile...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or fa...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts

Normand Informatique - Remisol Advance - Class 2 Recall
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2017 Category: Medical Devices Source Type: alerts

Laserex Systems Inc. - Tango Reflex - Class 2 Recall
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Partners In Medicine Llc - Task Force Monitor 3040 - Class 2 Recall
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be ...
Source: Medical Device Recalls - January 5, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic, Restore¿ (37711), RestoreADVANCED¿ (37713), RestoreADVANCED¿ SureScan¿ MRI (97713), RestoreSENSOR¿ (37714), RestoreSENSOR¿ SureScan¿ MRI (97714),PrimeAdvanced¿ SureScan MRI, (97702),RestoreULTRA¿ (37712),RestoreULTRA¿ SureScan¿ MRI (97712) Itrel¿4 (37703),Itrel¿4 (37704),RestorePrime¿ (37701),PrimeAdvanced¿ (37702), Spinal cord Stimulation for chronic pain. All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711),...
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts

Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsu...
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts