12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Baby Gorilla/Gorilla Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
GORILLA/BABY GORILLA PLATING SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC·Product code HRS·September 17, 2020
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017897·K-Wire, Double Ended, Trocar Point, Diameter Si...
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 36cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036329·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017903·K-Wire, Double Ended, Trocar Point, Diameter 0....
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 28, 2011
ARTHROSCOPE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 26, 2013
PFC SIGMA C/S NPOR FEM RT SZ 4
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 3, 2008
PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023
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