18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PARAPOST XT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
JAKOBI SURG. INSTRUMENTS #3 21/22/24
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
I.V. START KIT (AHC-50-54954
FDA 510(k)
FDA Class 1
·General Hospital
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 3, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 1, 2014
VASOVIEW 6 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 8, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010
ARCOS 15X190MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 19, 2024
UNKNOWN CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·February 19, 2024
NCB®, LOCKING CAP
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·March 12, 2024
NCB®, SCREW, ø 5.0, 42 MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·March 12, 2024
ARCOS CON SZ B HI 70MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 19, 2024
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
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