12 results · 21ms · Sources: EU EUDAMED, 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