11 results · 21ms · Sources: EU EUDAMED, US FDA

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MP-1 MICROPERIMETER

FDA 510(k)
FDA Class 2 ·Ophthalmic

OCCU-FLO PUNCTUM PLUGS

FDA 510(k)
FDA Unclassified ·Unknown

THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202

FDA 510(k)
FDA Class 2 ·Physical Medicine

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013

GPS PROCEDURAL STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FPO·June 13, 2008

UNICEL DXI WASH BUFFER II

FDA Adverse Event
BECKMAN COULTER INC.·Product code LDT·April 19, 2011

LUCAS 3 CHEST COMPRESSION SYSTEM

FDA Adverse Event
Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

LUCAS 3 CHEST COMPRESSION SYSTEM

FDA Adverse Event
Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

PVA FOAM EMBOLIZATION PARTICLES

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·March 26, 2018

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015