10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
EYETECT TREMOR MONITOR UNIT (TMU)
FDA 510(k)
FDA Class 2
·Neurology
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575407576·Orthopaedic bone nut - Endo Model Knee System
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
RADIAL HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
PALINDROME 23/40 KIT W/ SLOT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·February 12, 2013
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Injury
·OPTONOL, LTD.·Product code KYF·February 24, 2011
ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR - 11MM DIAMTER,100 MM LENGTH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GCJ·February 14, 2008
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024