9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
AIRCAST PNEUMATIC KNEE BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine
75H - Capitol Drywall - 2-Shelf Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588120942·75H - Capitol Drywall - 2-Shelf Cabinet
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120940·Self-Drilling Screw - Ø1.9 mm x 4 mm (3) [10 PK]
BRAIN BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 31, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2010
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015