13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClariFix
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017903·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....
CETRA
FDA UDI
Orthofix US LLC·18257200120543·3-LEVEL PLATE ASSEMBLY, 56MM
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042076·2 Upper Bicuspid Extraction w/Seating Springs
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
FDA 510(k)
FDA Class 2
·Anesthesiology
TDS PRECISION DENTAL BAR
FDA 510(k)
FDA Class 2
·Dental
GORILLA/BABY GORILLA PLATING SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC·Product code HRS·September 17, 2020
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·October 3, 2008
NEUROFORM 3 EZ- 4.5 X 20MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR CORK·Product code NJE·June 26, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 28, 2011
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018