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

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CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450274408·

MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)

FDA 510(k)
FDA Class 1 ·General Hospital

OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

CONSERVE(R) PLUS CUP

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 12, 2024

ENDO GIA

FDA Adverse Event
Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·May 4, 2021

ENDO GIA

FDA Adverse Event
Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·May 10, 2021

GORE DRYSEAL SHEATH

FDA Adverse Event
Injury ·W. L. GORE ASSOCIATES·Product code DYB·March 12, 2013

ARCHITECT HAVAB IGM REAGENT

FDA Adverse Event
Malfunction ·ABBOTT·Product code LOL·March 17, 2011

MOST OPTIONS HINGE KIT

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HRZ·March 27, 2008

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

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