9 results
·
29ms
·
Sources: EU EUDAMED, US FDA
SIGMA CO2 ACID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981089481·Paddle Scraper, Long, Convex, 9mm
POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IMRI 1.5T AND IMRI 3T S
FDA 510(k)
FDA Class 2
·Radiology
EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 29, 2023
ASR ACETABULAR IMPLANT 64
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·December 17, 2010
ARMADA 14 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·January 29, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014
Philips Azurion system; Software Version Number: R3.1;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026