14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
Tyber Medical, LLC·M695M1304190·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450801109·
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
VITERION 100 TELEHEALTH MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·September 26, 2013
VALIANT CAPTIVIA
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 24, 2013
SUPER SHEATH INTRODUCER SHEATH
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DYB·September 30, 2014
UNK SALINE IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·June 13, 2011
Universal Tray Catalog 1567
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·September 4, 2013
GALAXY G3 XSFT HEL 2MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·February 16, 2021
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