SEO landing
FDA Device Enforcement Reports
View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.
FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.
GE Healthcare, Avance, Avance CS2, Amingo.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·December 21, 2016
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·June 7, 2017
Autolube-III with NK Product Usage: Pneumatic system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 18, 2012
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
FDA Enforcement
Class II
·Terminated·AbbVie Inc.·June 7, 2017
11CM ANGLE ATTACHMENT, BLACK MAX
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
FDA Enforcement
Class III
·Terminated·Cooper Surgical, Inc.·April 3, 2013
PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
FDA Enforcement
Class II
·Terminated·ArthroCare Medical Corporation·July 1, 2015
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012