10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CROWNTEX EXAM. CAPE & GOWN
FDA 510(k)
FDA Class 1
·General Hospital
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110669·COAXIAL IRR-ASP- TIP 90 DEG- W/ SILICONE
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
FDA 510(k)
FDA Class 2
·Cardiovascular
CULTURE TUBE, (VACUTAINER)
FDA 510(k)
FDA Class 1
·Microbiology
THRUWAY GUIDE WIRES
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·March 7, 2011
CLEO 90 INFUSION SET
FDA Adverse Event
Injury
·SMITHS MEDICAL·Product code FPA·April 10, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 17, 2007
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2012
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015