17 results · 19ms · Sources: EU EUDAMED, US FDA

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CATHETER, NASAL, OXYGEN

FDA 510(k)
FDA Class 1 ·Anesthesiology

VuePoint

FDA UDI
Nuvasive, Inc.·00887517175670·VuePoint Screw, 4x20mm Fav Angle Tulip

Anti-nDNA IgG IFA 96 Test

FDA UDI
Hemagen Diagnostics, Inc.·G5229024201·For the detection and titration of anti-native ...

n/a

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080369·INSERTER 902-420 20MM OPEN ANT BD

HITACHI ALTAIRE

FDA 510(k)
FDA Class 2 ·Radiology

KRD1 PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

3.0 x 34CM HI-RES GALILEAN LOUPE - 902420

Device
EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

APTIMA COMBO 2 ASSAY

FDA Adverse Event
Injury ·HOLOGIC, INC.·Product code LSL·December 5, 2024

INTEGRAL/X POR RED PROX 13MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 18, 2019

ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GET·July 9, 2015

6600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 9, 2009

SELEX/MAGNUM MOD HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·October 24, 2018

FEMORAL MODULAR HEAD - S Ø28MM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code LPH·April 13, 2023

PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 2, 2019

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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