12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COULTER RETIC-C CELL CONTROL
FDA 510(k)
FDA Class 2
·Hematology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515237025·Tardy Osteotome, 6 1/4", 6mm wide edge
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8039301190·LONG COBB CURETTE 15" STRAIGHT #5
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRILL BIT Ø4.5/2.1 CANN CALIBR L230/210
FDA Adverse Event
Malfunction
·SYNTHES·Product code JDW·January 25, 2013
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP·Product code NBW·November 19, 2010
CAPSUREEPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·July 11, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015