21 results · 25ms · Sources: EU EUDAMED, US FDA

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PROPHY-MATE NEO

FDA 510(k)
FDA Class 1 ·Dental

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

2010 4 WAY STOPCOCK

FDA UDI
HANS RUDOLPH, INC.·00874750009619·2010A 2POS 4W .875FB 22MM/.75

RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 16, 2026

HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 16, 2026

HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 16, 2026

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
NEW PROKIN·Product code FSA·May 14, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 21, 2023

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021