17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GRADIA®
FDA UDI
Gc America Inc.·D0479010591·GRADIA PLUS Opaque OA, 2.0ml, 1 pc.
Sinutwist
FDA UDI
BRIVANT LIMITED·00816349011658·
Sinutwist
FDA UDI
BRIVANT LIMITED·00816349011634·
Sinutwist
FDA UDI
BRIVANT LIMITED·00816349011672·
Sinutwist
FDA UDI
BRIVANT LIMITED·00816349011627·
Sinutwist
FDA UDI
BRIVANT LIMITED·00816349011665·
Sinutwist
FDA UDI
BRIVANT LIMITED·00816349011641·
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FOXQ 980 LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·October 28, 2024
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 30, 2014
APOGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 3, 2013
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code KOG·November 10, 2010
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
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