13 results · 32ms · Sources: EU EUDAMED, US FDA

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OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

FDA 510(k)
FDA Class 2 ·Ophthalmic

Bernafon

FDA UDI
Bernafon AG·05711584049754·PC7 N, PS SF GB PRECISO 7

Pro-Link Ti

FDA UDI
Life Spine, Inc.·00190837081065·

BELIFU

FDA Adverse Event
Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

ESTHETIC ZIRCONIA ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

TACAMO MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·February 20, 2020

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NIK·October 1, 2014

SCRW,2.4X8MM CANCELOUS LOCKING

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·May 29, 2013

REVEAL XT

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·June 16, 2011

LOGIC KNEE COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 31, 2024

AMISTEM H HA COATED STD STEM SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2022

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015