13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY SIGMA TIBIAL INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033272·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FLO-BOOT
FDA 510(k)
FDA Class 1
·Physical Medicine
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·April 3, 2013
BD SYR NED UFLN SHRT 0.5ML 31G 5/16
FDA Adverse Event
Malfunction
·BD·Product code FMI·March 24, 2011
*
FDA Adverse Event
MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT·Product code DXY·April 11, 2008
BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·October 28, 2019
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024