9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
FDA 510(k)
FDA Class 2
·Hematology
Portex
FDA UDI
ICU MEDICAL, INC.·20351688061321·
HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS
FDA 510(k)
FDA Class 2
·Microbiology
FORCE 1C
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LRG TAP PRI MOD NCK 0DEG 38MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LZO·January 16, 2013
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 14, 2010
AV PLUS DX BIFURCATED BIPOLAR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024