13 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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PONTIC PAINT
FDA 510(k)
FDA Class 2
·Dental
ArgenZ ST 95x16 ML A2B
FDA UDI
ARGEN CORPORATION, THE·D818130237·Dental porcelain/ceramic restoration kit
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180623·Integra® Jarit® Adson Forceps, 4-5/8", Angled, ...
N/A
FDA UDI
Tyber Medical, LLC·M695M1302370·
DIALYSATE METER, MODEL D-6
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
BD WHITACRE SPINAL NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code BSP·March 27, 2007
UNKNOWN GUIDING CATHETER CARDIOLOGY
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code DQY·April 30, 2019
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 1, 2020
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