18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Therm-X
FDA 510(k)
FDA Class 2
·Physical Medicine
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017934·K-Wire, Double Ended, Trocar Point, Diameter Si...
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042625·Asian Non-Extraction
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
FDA 510(k)
FDA Class 1
·Dental
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 26, 2013
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·July 27, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC.·Product code LYJ·September 24, 2008
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018
RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·June 6, 2025
HEMOSIL ACUSTAR HIT-IGG (PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·April 8, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 1, 2015
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012