12 results
·
30ms
·
Sources: EU EUDAMED, US FDA
eMotus Respiratory Motion Management System
FDA 510(k)
FDA Class 2
·Radiology
Probes, Lacrimal
FDA UDI
KATENA PRODUCTS, INC.·00841668114353·LACRIMAL INTUBATION SET (BX/3)
Burr
FDA UDI
KATENA PRODUCTS, INC.·00841668113066·ALGERBRUSH II (OPHTHALMIC CORNEAL BURR)
DISCOVERY ELBOW HUMERAL CONDYLE KIT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·February 8, 2018
COMPREHENSIVE SRS/ DISCOVERY DISTAL BODY WITH SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·February 8, 2018
babyLance Safety Heelstick (BLM, BLN, BLP)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVi SCAN EEG System and Accessories
FDA 510(k)
FDA Class 2
·Neurology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
PACIFIC XTREME PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·INVATEC INNOVATIVE TECHNOLOGIES, SPA.·Product code LIT·August 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 11, 2014
ASR 300 SPIKED CUP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025