9 results · 28ms · Sources: EU EUDAMED, US FDA

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PRECISION FLOW

FDA 510(k)
FDA Class 2 ·Anesthesiology

SIMPLICITY SOFT QD MICRO INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

PAFLUFOCON C AND E DAILY CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

LINEAR 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 22, 2023

LOANER CORE SAG SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·April 23, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·April 29, 2011

KAPPA 700 DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·July 10, 2008

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015