11 results · 19ms · 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.

MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM

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

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040018415·New Gear Cervical Gel Cushions

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496061519·FREE LEGS, SIZE S, NERO, MICRO-MASSAGING ANTI-C...

AMEDA HYGIENIKIT

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

ACTICOAT 7 DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

PROTECTA XT DR

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 16, 2013

2-L HUB CONNECT ASSY REP LACEMENT SET

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code NFK·March 16, 2011

CLARION

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·June 17, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018