14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
FDA 510(k)
FDA Class 2
·Orthopedic
CONSTRAINED LINER
FDA 510(k)
FDA Class 2
·Orthopedic
ELISA TEST, SEROLOGY
FDA 510(k)
FDA Class 1
·Microbiology
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
HS HAND CONTROLLED CURVED SHEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·October 10, 2008
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
BIOMET CC CRUCIATE TRAY 75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 3, 2013
BD¿ BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code GAA·January 21, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·August 17, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·March 25, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021