20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
FDA 510(k)
FDA Class 2
·Radiology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC182532552·ET 25G 1" 3mL Syringe w/ exchangeable needle (TB)
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS·Product code LYJ·February 16, 2012
Aero Chrome* Breathable Performance Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXUS LIGATING CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOGLUE SURGICAL ADHESIVE
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MUQ·December 1, 2010
CONSTELLATION VISIOIN SYSTEM
FDA Adverse Event
Malfunction
·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·November 13, 2014
AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FNG·September 19, 2011
COULTER® LH 500 HEMATOLOGY INSTRUMENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 29, 2013
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 16, 2012
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·May 9, 2017
UNKNOWN BONE CEMENT
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LOD·December 10, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·December 5, 2019
VERSAONE
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code GCJ·August 14, 2024
VERSAONE
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code GCJ·June 18, 2025
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·August 7, 2013
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014