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

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SPIDERFX EMBOLIC PROTECTION DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

Epatch Sensor

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146EP070·

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

FDA 510(k)
FDA Class 1 ·Microbiology

AQUIFY LENS COMFORT DROPS

FDA 510(k)
FDA Class 2 ·Ophthalmic

HEARTSTART MRX -EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 27, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·June 19, 2008

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·April 12, 2011

ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery system 5mm x 14mm 80 cm .014" REF PMP4-5-14-80

FDA Recall
Terminated ·Product code FGE·January 29, 2004

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