46 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
CORRIDOR4DM V2010 MODEL: V2010
FDA 510(k)
FDA Class 2
·Radiology
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·June 14, 2013
COMPRESS ANCHOR PLUG
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code MBI·July 15, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 22, 2008
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 19, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 20, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 2, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·February 10, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 12, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 16, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·February 3, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 24, 2020
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022