11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONOSITE EDGE ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HHM
FDA UDI
Oticon A/S·05707131261649·H100, BTE 13 WL 85 CBE HHM
14 WIRE STANDARD, 14 WIRE LS
FDA 510(k)
FDA Class 2
·Cardiovascular
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
FDA 510(k)
FDA Class 2
·Immunology
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 29, 2013
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 20, 2011
MAROUIS DR
FDA Adverse Event
Injury
·MEDTRONIC INC.·Product code LWS·August 22, 2008
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·May 7, 2014
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 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