10 results · 27ms · Sources: EU EUDAMED, US FDA

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12SSL ECG ANALYSIS PROG.(SCALER LEAD)

FDA 510(k)

ACUMED

FDA UDI
Acumed LLC·10806378096297·1.6mm Wire Sleeve

HARDYDISK GENTAMICIN, 120MCG

FDA 510(k)
FDA Class 2 ·Microbiology

CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 19, 2012

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 9, 2014

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 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