10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
FDA 510(k)
FDA Unclassified
·Unknown
IV TRIFURCATED EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 25, 2021
ASR XL TAP SLV ADAP 12/14+2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 9, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 19, 2010
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 6, 2020
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025