16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW
FDA 510(k)
FDA Class 2
·Dental
Life Instruments
FDA UDI
Life Instrument Corporation·M930798051210·Stainless Frazier Suction 12FR 4.5" from bend
Life Instruments
FDA UDI
Life Instrument Corporation·M9307980512110·Custom Frazier w/holes 12Fr, 5" from 40° bend
AUTO/STAT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
FDA 510(k)
FDA Class 2
·Ophthalmic
ARTICULEZE M HEAD 36MM +5 K980513
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 14, 2016
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·February 21, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·August 5, 2014
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 4, 2025
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013