83 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 17, 2015
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016
Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 15, 2016
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.
FDA Enforcement
Class II
·Terminated·Mesa Laboratories, Inc.·November 13, 2013
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·February 19, 2014
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·April 30, 2014
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·January 13, 2014
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. Intended to monitor blood glucose from samples taken from the body. IVD use only,
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·February 19, 2014
Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
FDA Recall
Terminated
·Covidien LLC·Product code CCX·May 8, 2014
Custom Made Implant System with Minimum Invasive Grower (MIG) component
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code JDO·December 21, 2017
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·February 14, 2014
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·March 13, 2014
K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
FDA Recall
Terminated
·Breg Inc·Product code IQI·March 14, 2014
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
FDA Recall
Terminated
·Breg Inc·Product code IQI·March 14, 2014