11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3DKNEE POROUS COATED FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032905·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs B...
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER,
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·February 9, 2023
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 29, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 23, 2008
14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00227).
FDA Recall
Terminated
·Abbott Laboratories·Product code LNO·November 12, 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
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