10 results
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25ms
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Sources: EU EUDAMED, US FDA
PRECISION OPTICS IMAGE COUPLER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BBIG
FDA UDI
BBig B.V.·08719616011738·4903458
Brigade
FDA UDI
Nuvasive, Inc.·00887517962706·Brigade Lateral Trial, 10x34x32mm 15°
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 30, 2014
CQUR TACSHIELD
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·January 4, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 26, 2007
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 20, 2017
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