8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FLO-GARD(R) 6301
FDA 510(k)
FDA Class 2
·General Hospital
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO MODEL 90-1460 LASER ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 4, 2014
PALMAZ XL STENT PER 50MM OUS
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code FGE·January 15, 2013
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·February 2, 2008
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015