20 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Health Line CT Midline Catheter
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III
ARROW
FDA UDI
TELEFLEX INCORPORATED·10801902140873·Pediatric Two-Lumen Central Venous Catheterizat...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694034470·PROFILE ZERO 1.6MM SCREWDRIVER SHAFT, MANUAL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021965·
GO MEDICAL BALLOON INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
LOGIQ 3
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 20, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 15, 2023
PRODIGY AUTO CODE
FDA Adverse Event
Injury
·OK BIOTECH COMPANY LTD·Product code NBW·September 30, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
RESERVOIR 3ML MMT-332A
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FRN·June 15, 2018
PHYSICA TT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBH·May 6, 2025
SMR SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code HSD·May 14, 2026
2" FLEX QC SHAFT EXTENSION
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code MQN·October 2, 2008
ZEPHYR XL SR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·August 11, 2011
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 1, 2013
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·October 20, 2016
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014