15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
OCCU-FLO PUNCTUM PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
Preat
FDA UDI
Preat Corporation·00842092169834·ASC Biomet 3i Certain®-compatible 4.1mm X 9mm E...
NBS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·Dental
FEMORAL COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 17, 2024
2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 11, 2013
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 25, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 19, 2008
UNK_MONOFOCAL IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·June 25, 2025
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 17, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024