15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071648·STRIPE GAME CASSIOPEA, SIZE XL, NERO, GRADUATED...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293777·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049910·Steinmann Pins, Single diamond, 3 shank end, 0....
RANDOX CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTRASTENT DOUBLESTRUT PARAMOUNT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 6, 2023
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 22, 2024
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 6, 2021
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 18, 2019
REVEAL XT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DSI·April 22, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·April 15, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIQ·July 8, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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