10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640076·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694033008·EnCompass Lesser Broach
MC1 Plus
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 7, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012