35 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008
Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.
FDA Recall
Terminated
·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·November 30, 2009
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
FDA Recall
Terminated
·Musculoskeletal Transplant Foundation, Inc.·Product code HXY·May 27, 2015
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
FDA Recall
Terminated
·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
FDA Recall
Terminated
·Allen Medical Systems·Product code JEB·October 6, 2017
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
FDA Recall
Terminated
·SunMed Holdings, LLC·Product code CBT·September 8, 2022
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
FDA Recall
Terminated
·Allen Medical Systems·Product code JEB·October 6, 2017
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
FDA Recall
Terminated
·Musculoskeletal Transplant Foundation, Inc.·Product code MBP·April 21, 2016
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
FDA Recall
Terminated
·Allergan Inc·Product code LCJ·June 18, 2015
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
FDA Recall
Terminated
·Allen Medical Systems·Product code N/A·February 21, 2018
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
FDA Recall
Terminated
·Allergan Inc·Product code MRD·June 8, 2015
GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008
Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.
FDA Recall
Terminated
·Sun Med, Inc.·Product code CCW·April 27, 2007
Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
FDA Recall
Terminated
·Allen Medical Systems, Inc. One Post Office Square·Product code HST·February 28, 2013
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
FDA Recall
Terminated
·Allergan Inc·Product code LCJ·June 18, 2015
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
FDA Recall
Terminated
·Diamedix Corporation·Product code LJY·January 5, 2018
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
FDA Recall
Terminated
·Sun Med, LLC·Product code BTM·May 24, 2018
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
FDA Recall
Terminated
·Sun Med, LLC·Product code BTM·May 24, 2018