8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AUTOWAND(TM) 7XXX SERIES, MODIFICATION
FDA 510(k)
FDA Class 2
·Anesthesiology
LOCKBOX
FDA 510(k)
FDA Class 2
·General Hospital
PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
FDA 510(k)
FDA Class 2
·Radiology
WHITESTAR SIGNATURE¿ SYSTEM
FDA Adverse Event
ABBOTT MEDICAL OPTICS·Product code HQC·January 9, 2013
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 22, 2010
INCEPTA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024