22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STARband, STARlight
FDA 510(k)
FDA Class 2
·Neurology
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095620420·Pipette tip,100-1000uL,natural for MLA
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIDEKICK BLOOD GLUCOSE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WST 6:1 F. VDW.GOLD/SILVER
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EGS·March 28, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·June 30, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
SINGLE USE ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code KTI·February 17, 2023
SINGLE USE ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code KTI·February 17, 2023
SINGLE USE ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code KTI·February 17, 2023
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 3, 2020
SINGLE USE ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code KTI·February 17, 2023
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·March 28, 2017
AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
dS Breast 16ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024