14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THE SCREENER GSI 55 ABR SCREENER
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707033097·WEB 1ST MOLAR BANDS n.LL 30
POSITRACE
FDA UDI
Conmed Corporation·10653405004523·Adult Foam ECG Positrace Diaphoretic Conductive...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327300055·PEEK CUSTOMIZED-PLUS-L
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014
Arthrex®
FDA UDI
ARTHREX, INC.·10888867312767·Guidewire, Trocar, 1.1mm
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
NOVATECH TALCAIR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3DKNEE
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code JWH·June 12, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE MOUNTAIN HOME·Product code FKX·October 15, 2010
MODEL NOT SPECIFIED
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·December 12, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024