16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALARIS SYRINGE PUMP
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 12, 2021
1.5T 16-CHANNEL HAND-WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONE TOUCH BASIC ENHANCED
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 19, 2002
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 13, 2021
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 30, 2023
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·May 29, 2013
NAVIGATED CD HORIZON® SOLERA¿ REDUCTION 4.75 SCREWDRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·October 1, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 19, 2011
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 22, 2017
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
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