17 results · 30ms · Sources: EU EUDAMED, US FDA

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MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496073024·STRIPE GAME CRONO, SIZE M, NERO, GRADUATED COMP...

AutoPulse®Resuscitation System

FDA UDI
Zoll Circulation, Inc.·00849111000659·The AutoPulse System consists of 4 primary comp...

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02

FDA 510(k)
FDA Class 2 ·Radiology

SELECTIVA GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2020

AutoPulse®Resuscitation System

FDA UDI
Zoll Circulation, Inc.·00849111000918·The AutoPulse System consists of 4 primary comp...

SILCONE COATED I/A 45 HANDHELD INSTRUMENT

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·May 7, 2019

GRAFTYS BCP (510K NUMBER: K073064)

FDA Adverse Event
Injury ·GRAFTYS·Product code MQV·July 11, 2013

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

ATLAS VR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

HEAD/NECK 24 STRETCH

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

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

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

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