10 results
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18ms
·
Sources: EU EUDAMED, US FDA
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223280·Cervical Trial 10x18x14 Lordotic
SteriCUBE® Multiple Tray Sterilization Systems
FDA 510(k)
FDA Class 2
·General Hospital
EMS PIEZON MASTER 600
FDA 510(k)
FDA Class 2
·Dental
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·May 20, 2014
WASHER 7.0MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HTN·November 7, 2012
LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 1, 2010
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025