13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
FDA 510(k)
FDA Unclassified
·Unknown
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331173554·wagner plastic surgery scissors, fine pattern, ...
Plateau C
FDA UDI
Life Spine, Inc.·00190837093846·
OMNIFIT HFX HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 29, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
GATEWAY PTA DILATION CATHETER
FDA Adverse Event
Death
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code GBA·August 21, 2008
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 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