12 results
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28ms
·
Sources: EU EUDAMED, US FDA
AKUPORT M1
FDA 510(k)
FDA Class 2
·Neurology
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093585·Mini Uni-Twin(TM) Bracket APC(TM) PLUS L1,2 -5T...
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062567·Mini Uni-Twin(TM) Bracket APC(TM) II L1,2 -5T/0...
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717107306·Midway Select Disposable Diamonds 858-014SC Pkg/25
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016652·Mini Uni-Twin(TM) Bracket L1,2 -5T/0A .022 5/Pk
ULTRASOUND SCANNER TYPE 2102
FDA 510(k)
FDA Class 2
·Radiology
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007
BRILLIANCE BIGBORE ONCOLOGY
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·March 20, 2013
BV LIBRA
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZL·February 10, 2011
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