15 results · 22ms · Sources: EU EUDAMED, US FDA

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MODULAR FOOT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I

FDA 510(k)
FDA Class 2 ·Cardiovascular

REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 29, 2024

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
MEDEL S.P.A.·Product code BTI·April 23, 2013

CROSSER 14P RX

FDA Adverse Event
Injury ·BARD·Product code DQY·April 18, 2011

DAMON COPPER NITI WIRE

FDA Adverse Event
Malfunction ·ORMCO CORPORATION·Product code DZC·July 11, 2008

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022

DIMENSION EXL WITH LM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

PROFILE 3D

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021

DIMENSION EXL 200

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013

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

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016