11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PERITONEAL DIALYSIS CYCLER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sphero Attachments
FDA UDI
Preat Corporation·00842092121566·Sphero Block Abutment Nobel Active NP x 1mm (2....
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130690·Drill Bit, 1.2mm diam., 10mm
BIOSPEED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·February 2, 2007
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·May 15, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 15, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025