14 results
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25ms
·
Sources: EU EUDAMED, US FDA
BNOS MICROVENT(TM), MODEL AC AND MODEL AO
FDA 510(k)
FDA Class 2
·Anesthesiology
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79305331·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79305330101·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79305330051·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79305331001·Mini Sprint II Bracket FACE Evolution II System...
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2016
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 24, 2013
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015