21 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Astroglide Organix Gel
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777631·LUMBAMED BASIC DORSAL STAYS M SILVER I
PROFYLE
FDA UDI
Stryker GmbH·04546540256041·Drill Guide, L, Eccentric
Accent Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989054293·ORTHOS ACCENT 15DBL UFM -10X22X21 RT
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706008·Molt (Dingman) Periosteal Elevator #9 - D/E Blu...
TOUCH&BOND-PLUS
FDA 510(k)
FDA Class 2
·Dental
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
FDA 510(k)
FDA Class 2
·Hematology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 31, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 12, 2022
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·July 30, 2020
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 1, 2024
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 18, 2019
COMPOSITCP 30 INTERFERENCE SCREW 9MM X 25MM
FDA Adverse Event
Malfunction
·BIOMET SPORTS MEDICINE, INC.·Product code HWC·August 11, 2011
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 24, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 1, 2013
LINER FOR METAL BACK GLENOID STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·November 23, 2020
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 5, 2012
SPECTRA OPTIA
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·September 9, 2020
BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56"
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 12, 2022
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