10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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