8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MIDDLEBROOK & COHN 7H11 AGAR BASE
FDA 510(k)
FDA Class 1
·Microbiology
DAC-CEL DIAGNATAL HCG STANDARDS RD49
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MULTIPLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2012
OCTRODE LEAD KIT, 30CM LENGTH
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023