21 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
FDA Recall
Terminated
·Zimmer Trabecular Metal Technology, Inc.·Product code HXB·December 2, 2014
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
FDA Recall
Terminated
·SpineFrontier, Inc.·Product code HXB·September 11, 2013
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Enforcement
Class II
·Terminated·Centers For Disease Control and Prevention·July 3, 2024
HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH·July 2, 2014
VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·December 17, 2009
Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·January 13, 2009
Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·May 14, 2010
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
FDA Recall
Terminated
·Product code FGE·August 1, 2005
AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.
FDA Recall
Terminated
·Alter-G, Incorporated·Product code BXB·July 15, 2011
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
FDA Recall
Terminated
·Accelerated Care Plus Corporation·Product code BXB·June 12, 2013
Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients.
FDA Recall
Terminated
·Hocoma AG Florastrasse 47 Zuerich Switzerland·Product code BXB·May 27, 2009
Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.) Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark. These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code EXB·July 27, 2011
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.
FDA Recall
Terminated
·BioMotion Medical Systems, LLC·Product code BXB·November 12, 2012
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
FDA Recall
Terminated
·Convatec Inc.·Product code EXB·June 22, 2011
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.
FDA Recall
Terminated
·Convatec Inc.·Product code EXB·February 1, 2011
Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558
FDA Recall
Terminated
·ConvaTec·Product code EXB·February 14, 2008
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
FDA Recall
Terminated
·ConvaTec·Product code EXB·March 7, 2008
Go Bed II+ Model FL 28 Ex 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 Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·May 17, 2012
Go Bed II+ Model FL 28 Ex 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