9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOUBLE SPRINGERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
Edge™ Diamond BR037-7M Barrel
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172007450·Diamond dental bur, reusable
SOUNDCHOICE K-AMP
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONGER(TM) CABLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·January 26, 2011
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·July 8, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021