9 results · 19ms · Sources: EU EUDAMED, US FDA

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Arthrex SwiveLock Anchor

FDA 510(k)
FDA Class 2 ·Orthopedic

WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANCURE LLIAC BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD LOGIC BLOOD GLUCOSE MONITOR

FDA Adverse Event
Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 17, 2008

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

UNKNOWN LEAD

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·July 2, 2013

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021