14 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PENTACAM SCHEIMPFLUG CAMERA

FDA 510(k)
FDA Class 2 ·Ophthalmic

LIFECARE CONDUCTIVE GARMENTS

FDA 510(k)
FDA Class 2 ·Neurology

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2013

ELLIPSE DR, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·September 30, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 13, 2013

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 3, 2013

ENDOWRIST

FDA Adverse Event
Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022

FLEXITRUNK INFANT INTERFACE NASAL TUBING

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·February 12, 2014

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 23, 2014

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 20, 2013

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 4, 2013

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019