9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RETROFIT BABY FACE SHIELD (RFS)
FDA 510(k)
FDA Class 2
·General Hospital
6MP Color LCD Monitor (C61W+)
FDA 510(k)
FDA Class 2
·Radiology
A-LAP SET (A-LAP, EZAXESS, TROCAR)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 26, 2010
CANNULATED SCREW
FDA Adverse Event
Injury
·Product code HWC·December 20, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 18, 2014
OMNISPAN MENISCAL REPAIR 12DEG
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 18, 2019
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems (Cleveland) Inc·November 13, 2019
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