11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MANOMETER SET C.V.P. #S 298/299
FDA 510(k)
FDA Class 2
·Cardiovascular
DROPLET PEN NEEDLES 31G 8MM
FDA Adverse Event
Injury
·HIGH TECH LAB /HTL-STREFA, INC.·Product code FMI·September 13, 2022
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
FDA 510(k)
FDA Class 2
·Ophthalmic
NEEDLE
FDA Adverse Event
Injury
·UNK·Product code FMI·October 9, 2018
NEEDLE (PEN NEEDLE DISPOSABLE)
FDA Adverse Event
Injury
·UNKNOWN·Product code FMI·March 18, 2020
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 23, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2015
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
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