17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLARIS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Kendall
FDA UDI
Cardinal Health, Inc.·10884527014491·Scalpel #15
Kendall
FDA UDI
Cardinal Health 200, LLC·10192253051841·Scalpel
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK116151·DD tempMED are pre-colored dental milling blank...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694033848·Low Profile 2x2 Hole Small Plate
3D Printed Interbody System
FDA UDI
Seaspine Orthopedics Corporation·10889981303679·Interbody, 39mm x 30mm x 16mm, 15 Deg, 3D
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981215163·Interbody, 39mm x 30mm x 16mm, 15 Deg
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981217068·Trial, 39mm x 30mm x 16mm, 15 Deg
POWERWIRE RADIOFREQUENCY GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SLED CURING LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156504·Tesera-k ALIF, 31W X 26D, 15mm, 12° Trial
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151585·Tesera-k SA, 31mm X 26mm X 15mm, 12° Lordosis, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157259·Tesera-k ALIF, 31W X 26D, 15mm, 12° Broach
SHUNT DENVER ASCITES PAK DOUBLE VALVE
FDA Adverse Event
Malfunction
·CAREFUSION·Product code KPM·October 1, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 17, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 16, 2011
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019