11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYFRECATOR, #733
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUMED
FDA UDI
Acumed LLC·10806378043482·Locking Pliers, Small
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127026812·Shortened Dual Taper Broach, Size 17
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 8, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007
regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021