10 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ACKRAD PEDIATRIC C.P.A.P. SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SHARPSITE®
FDA UDI
MEDTRONIC XOMED, INC.·00681490047036·ENDOSCOPE 1880161 SHARPSITE 2.7MM/30DEG
Sharpsite®
FDA UDI
MEDTRONIC XOMED, INC.·00643169937413·ENDOSCOPE 1880161 SHARPSITE 2.7MM/30DEG
Viz CTP
FDA 510(k)
FDA Class 2
·Radiology
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSINE SAMARITAN 500P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE·Product code MKJ·May 6, 2014
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·October 22, 2010
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020