8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EZ-HBT HELICOBACTER BLOOD TEST
FDA 510(k)
FDA Class 1
·Microbiology
(800,103 P37,RAULAND 800,BED EXIT,2 LIGHTS,22 OHM,CLAMP,MOLDED
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828174916·800,103 P37,RAULAND 800,BED EXIT,2 LIGHTS,22 OH...
CORRUGATED TUBE WITH MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
FDA 510(k)
FDA Class 1
·Dental
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 6, 2013
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·February 10, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021