9 results
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15ms
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Sources: EU EUDAMED, US FDA
Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·April 10, 2013
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
FDA Enforcement
Class II
·Terminated·Amd Ritmed·April 6, 2016
PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·November 30, 2016
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 7, 2017
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·December 18, 2013
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples
FDA Enforcement
Class II
·Terminated·Aspen Surgical Products, Inc.·August 28, 2013
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
FDA Enforcement
Class II
·Terminated·Cyberonics, Inc·August 23, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012