8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PECGASYS REMOTE TRANSMISSION UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
STEALTH 360 ORBITAL PAD SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
T-SHAPE 2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 23, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 2, 2012
PROMOTE ACCEL CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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