14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450255476·
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
FDA 510(k)
FDA Class 2
·General Hospital
CONDUCTIVE GEL FOR ULTRASOUND
FDA 510(k)
FDA Class 2
·Neurology
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
LIFESTENT VALEO VASCULAR STENT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·August 9, 2010
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
VALEO VASCULAR STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
LAMITRODE 44
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·September 2, 2014
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
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021