20 results · 31ms · Sources: EU EUDAMED, US FDA

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FLEXCERA BASE

FDA Adverse Event
Malfunction ·ENVISIONTEC GMBH·Product code EBI·November 10, 2021

E-Denture Pro

FDA 510(k)
FDA Class 2 ·Dental

Ophthalmic Hooks

FDA UDI
KATENA PRODUCTS, INC.·00841668114315·PUSH-PULL HOOK ANGLED (BX/3)

BIOLOK SCREW, BIOSTEON SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

DATEX-OHMEDA HMEF MINI

FDA 510(k)
FDA Class 2 ·Anesthesiology

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2025

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 8, 2026

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026

ROTABLATOR GUIDE WIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code MCX·October 16, 2008

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·July 3, 2013

BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 28, 2022

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2025

CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 7, 2022

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024

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