12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KEGEL8 PELVIC EXERCISER, MODEL OPH 400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AURECAST 40 B
FDA 510(k)
FDA Class 2
·Dental
VIVA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 8, 2021
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
BD INTIMA-II 20GAX1.16IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 10, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 29, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 12, 2011
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM·Product code DZE·July 8, 2008
BD INTIMA-II 20GAX1.16IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·November 27, 2024
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