17 results
·
35ms
·
Sources: EU EUDAMED, US FDA
OPLUS TIBIAL INSERT, 10 MM
FDA Adverse Event
Injury
·ORTHOMET, INC.·Product code HSH·July 25, 1994
*
FDA Adverse Event
STRYKER HOWMEDICA·Product code JWH·September 7, 2004
ASTRA ORTHOMED, INC.
FDA registration
ASTRA ORTHOMED, INC.·1 product·🇺🇸 United States
Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle
FDA Recall
Terminated
·Lang Dental Mfg Co, Inc.·Product code EBG·June 7, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 3
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JIX·May 27, 2022
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Injury
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 22, 2019
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Injury
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·August 29, 2025
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JIX·December 20, 2023
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·April 15, 2019
VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Injury
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·February 16, 2024
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Injury
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·December 17, 2024
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 23, 2022
VITROS CHEMISTRY PRODUCTS CREA SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JFY·August 26, 2025
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Injury
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·March 27, 2024
VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MZF·November 5, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MZF·September 19, 2022
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices