8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
THE ADVANCED OSMOMETER (3900)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HANDY VIBRO BELT
FDA 510(k)
FDA Class 1
·Physical Medicine
PROTECTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 15, 2013
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·July 29, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
FDA Recall
Open, Classified
·Nipro Renal Soultions USA, Corporation·Product code KPO·April 11, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021