10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANTA T-GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RF-IVD WIRELESS DOSIMETER-MODEL 1133
FDA 510(k)
FDA Class 2
·Radiology
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 25, 1998
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 9, 1998
VICRYL SUTURE, SH NEEDLE, 2-0
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GCJ·April 10, 2013
SPHERX DEFORMITY SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·April 1, 2011
MODEL-TRANSEND 135-CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORAITON·Product code DQX·May 23, 2008
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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024