18 results · 31ms · Sources: EU EUDAMED, 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