10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
ALPHA BIO BONE FIXATION SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EVACUATOR TIPS
FDA 510(k)
FDA Class 1
·Dental
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 8, 2024
PINNACLE MTL INS NEUT28IDX48OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·March 19, 2013
PRIMUS
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL GMBH·Product code BSZ·May 14, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 15, 2013
BARD 6.6 FR LOW-PROFILE SILICONE PORT
FDA Adverse Event
Injury
·BARD·Product code LJT·January 11, 2011
ARTICUL/EZE BALL 28 +5 BR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·March 19, 2013
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021