14 results · 22ms · Sources: EU EUDAMED, 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