10 results · 27ms · Sources: EU EUDAMED, US FDA

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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