16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Remi Robotic Navigation System
FDA 510(k)
FDA Class 2
·Neurology
X-CORE
FDA UDI
Nuvasive, Inc.·00887517490339·XLIF Corp Blade, 70mm Lung Retractor Nrw
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113714·CYSTOTOME REVERSED FORM 25GA
REAMER HEAD 7.0mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000580·
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GALILEOS FAMILY
FDA 510(k)
FDA Class 2
·Radiology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 28, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 20, 2013
6.5CM ADULT CRANI ATTACHMT
FDA Adverse Event
Injury
·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 4, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·December 30, 2016
LIAISON SARS-COV-2 AG
FDA Adverse Event
Malfunction
·DIASORIN ITALIA S.P.A.·Product code QKP·March 19, 2024
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 28, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018