10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
FDA 510(k)
FDA Class 2
·Physical Medicine
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
FDA 510(k)
FDA Class 2
·Microbiology
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2014
SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FDI·May 10, 2011
DURAGEN 3X3 SINGLE EXPORT
FDA Adverse Event
Other
·INTEGRA LIFESCIENCES·Product code GXQ·July 29, 2008
STARDRIVE SCREWDRIVER T25
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·April 25, 2019
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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