13 results
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20ms
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Sources: EU EUDAMED, US FDA
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
FDA 510(k)
FDA Class 1
·Dental
HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
UNKNOWN
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·December 29, 2024
AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
UNSPECIFIED CENTRAL LINE TRANSDUCER SET
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024
AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·April 10, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 19, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 12, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012