9 results · 20ms · Sources: EU EUDAMED, US FDA

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SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)

FDA 510(k)
FDA Class 2 ·Orthopedic

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·May 14, 2018

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

REPROCESSED PULSE OXIMETER SENSORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

9611993-2025-052677

FDA Adverse Event
Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·February 28, 2025

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 2, 2014

ALTRUA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 13, 2011

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