9 results
·
32ms
·
Sources: EU EUDAMED, US FDA
ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111205187·GUYON SOUND W/O THREAD 15FR
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209119738·
TOMCAT Cervical Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
SIROENDO
FDA 510(k)
FDA Class 1
·Dental
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 5, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 4, 2010
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD.·Product code MKJ·November 26, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022