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