8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Lumify Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
GAMMA-B 1,25-DIHYDROXY VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
InterActive Complete Surgical Tray
FDA 510(k)
FDA Class 2
·General Hospital
OVERJET CARIES ASSIST
FDA Adverse Event
Malfunction
·OVERJET·Product code MYN·February 18, 2025
ICAST COVERED STENT
FDA Adverse Event
Other
·ATRIUM MEDICAL CORP.·Product code NIO·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
M2A-38 CUP NON FLARED SIZE 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 23, 2013
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025