14 results · 24ms · Sources: EU EUDAMED, 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