25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROMOS MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109251·HA PEEK EVOS Straight, ,12mmx8mmx 26mm , FLAT 5...
Super Bypass
FDA UDI
TAKAYAMA INSTRUMENTS INC.·04580036674094·SuperBypass SI system Tip, 130mm, 1.2mm [3.6Fr]...
Grappler™ Suture Anchor System
FDA UDI
Paragon 28, Inc.·00889795132277·Grappler Suture Anchor, Titanium, ø3.0 x 12mm, ...
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
FDA 510(k)
FDA Class 1
·Microbiology
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·September 18, 2020
SUTURE ANCHOR TITANIUM 3.0X12MM SK
FDA Adverse Event
Injury
·PARAGON 28·Product code MBI·April 30, 2026
SUTURE ANCHOR TITANIUM 3.0X12MM SK
FDA Adverse Event
Injury
·PARAGON 28·Product code MBI·April 30, 2026
SUTURE ANCHOR TITANIUM 3.0X12MM SK
FDA Adverse Event
Injury
·PARAGON 28·Product code MBI·April 30, 2026
SUTURE ANCHOR TITANIUM 3.0X12MM SK
FDA Adverse Event
Injury
·PARAGON 28·Product code MBI·April 30, 2026
SUTURE ANCHOR TITANIUM 3.0X12MM SK
FDA Adverse Event
Injury
·PARAGON 28·Product code MBI·April 30, 2026
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 25, 2018
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 6, 2024
INFERIOR END PLATE MEDIUM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 15, 2013
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·June 3, 2011
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
NI
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 3, 2023