14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
RABBIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201501627·MRI COIL ADAPTER UNIVERSAL
20GA Illuminating Laser Probe, SMA905
FDA UDI
Peregrine Surgical, Llc·00632307001949·20GA Illuminating Laser Probe, SMA905
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935103486·
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
FDA 510(k)
FDA Class 2
·Neurology
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
FDA 510(k)
FDA Class 2
·General Hospital
ANGIODYNAMICS MORPHEUS SMART PICC CT
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC·Product code LJS·April 2, 2013
ENDOTAK ENDURANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 5, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·May 7, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018