16 results · 25ms · 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.

RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

STERICHEK TOTAL CHLORINE REAGENT STRIPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110

FDA 510(k)
FDA Class 2 ·Cardiovascular

GDC POWER SUPPLY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

FDA Adverse Event
Malfunction ·REYNOSA MANUFACTURING·Product code FKX·March 21, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·March 28, 2008

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

PINNACLE SECTOR II CUP 48MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 6, 2023

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

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

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