11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NO-HOIL COMBOSTAT II KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517369079·CoRoent LO Trial, 10x10x35mm 5°
Bioplate®
FDA UDI
Bioplate, Inc.·M3848133100·Short Screwdriver Blade - Ø1.5 mm - Handle (A)
SnuggleFit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022586·SnuggleFit Infant Effort Belt - SUM
ENDOGATER AVANTAGE CO2 INSUFFLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PVS BASIC 2; EPIC 2
FDA 510(k)
FDA Class 2
·Ophthalmic
QUANTUM 2 CONTROLLER
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·March 28, 2014
SENSIA S
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·October 31, 2012
RADIAL JAW 3 BIOPSY FORCEPS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·August 24, 2010
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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