10 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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EndoSerter-PL
FDA 510(k)
FDA Class 1
·Ophthalmic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114124·CHARLEUS CORTEX EXTR 23GA 16MM PK/10
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
FDA 510(k)
FDA Class 2
·Radiology
COMPAX 40E
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code IZZ·October 16, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·July 3, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012