178 results
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16ms
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Sources: EU EUDAMED, US FDA
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·February 28, 2024
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·December 13, 2023
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·December 13, 2023
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc.·July 8, 2020
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·June 11, 2014
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·December 10, 2014
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·July 16, 2014
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
FDA Enforcement
Class II
·Terminated·B Braun Medical Inc·April 20, 2022
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·November 6, 2013
Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.
FDA Enforcement
Class II
·Terminated·Dick's Sporting Goods·January 28, 2015
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Renal Div·August 8, 2012
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 20, 2012
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·January 15, 2014
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015