12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 25, 2025
VISION 9000 PHASED ARRAY TORSO COIL
FDA 510(k)
FDA Class 2
·Radiology
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEEVA BABY FETAL DOPPLER
FDA Adverse Event
Injury
·CONTEC MEDICAL SYSTEM CO., LTD.·Product code KNG·October 27, 2020
SONOLINE B (FETAL DOPPLER)
FDA Adverse Event
Injury
·BABY DOPPLER / DAGAMMA INC.·Product code HGM·January 17, 2019
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 13, 2025
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·April 25, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 10, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 25, 2008
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