27 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925040267·SICKLE KNIFE DISPOSABLE SINUS ENDOSCOPY
K133801
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024
n/a
FDA UDI
Ortho Development Corporation·00822409070312·Snap-on Fem Augment Trial 8mm Distal Size 3
K2M General Instruments
FDA UDI
VB Spine LLC·10888857562332·Lordotic Trial Size 22x50x7 mm, 8°
n/a
FDA UDI
Ortho Development Corporation·00822409066971·Stem Extension Trial Diameter 13x80mm
Portex
FDA UDI
ICU MEDICAL, INC.·15019517084030·
ADVIA Centaur® Cuvettes
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD
Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder
FDA UDI
VASOMEDICAL, INC.·00817980020030·12 CH ECG Holter Ultra Recorder
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PUMA MODEL VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015
GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 24, 2013
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
CAPIOX FX15
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·July 5, 2023
CAPIOX CUSTOM PACK
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·April 2, 2024