13 results · 21ms · Sources: EU EUDAMED, US FDA

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Stainless Turbine

FDA 510(k)
FDA Class 1 ·Dental

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

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·March 25, 2025

NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

CAVEX TEMPORARY CEMENT

FDA 510(k)
FDA Class 2 ·Dental

IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 6, 2019

HS ACE 14 CM SCISSOR HANDLE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 10, 2008

URETEX TO2 URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·April 4, 2013

CAPSUREFIX NOVUS MRI

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

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