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

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STOCKERT CORONARY PERFUSION CANNULAE

FDA 510(k)
FDA Class 2 ·Cardiovascular

STOCKERT CORONARY PERFUSION CANNULAE

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

nSpire Health

FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981173692·Closed, Axial Rod, Long, 280mm

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

FDA 510(k)
FDA Class 2 ·Orthopedic

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602

FDA 510(k)
FDA Class 3 ·Cardiovascular

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 27, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·March 17, 2011

APEX FLEX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·March 26, 2008

FALLOPIAN TUBE OCCLUSION INSERT

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

FALLOPIAN TUBE OCCLUSION INSERT

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

FALLOPIAN TUBE OCCLUSION INSERT

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

FALLOPIAN TUBE OCCLUSION INSERT

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

FALLOPIAN TUBE OCCLUSION INSERT

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

FALLOPIAN TUBE OCCLUSION INSERT

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2023

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014