30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMOOTH OR THREADED METALLIC BONE FASTENER
FDA 510(k)
FDA Class 2
·Orthopedic
NC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381051·
LoFric® Primo™
FDA UDI
Wellspect AB·07333387043111·Single Use Urinary Catheter LoFric Primo Nelato...
LoFric® Primo™
FDA UDI
Wellspect AB·07392532135491·Single Use Urinary Catheter LoFric Primo Nelato...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053204·2.0mm Angled Locking Curved Plate, 8 Hole
Phantom® Fibula Nail System
FDA UDI
Paragon 28, Inc.·00889795146298·1.6mm x 400mm, Sterilization K-Wire Container
CREATION
FDA UDI
Gc Orthodontics America Inc.·D78813164000101·CREATION ROTH 018/L4 -17T 0A
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027087·
PRECISION FLOW(R) - HELIOX
FDA 510(k)
FDA Class 2
·Anesthesiology
STELLAR 150
FDA 510(k)
FDA Class 2
·Anesthesiology
BIM400 IMPLANT MAGNET
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 19, 2017
COCHLEAR BAHA ATTACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 26, 2016
ATTRACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 15, 2015
COCHLEAR BAHA ATTACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
BIM400 IMPLANT MAGNET
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016
SP MAGNET 3
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 13, 2016
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 14, 2017
COCHLEAR BAHA ATTRACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 14, 2016
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 8, 2017