23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006965·2.0mm/2.4mm Locking Strut Fracture Plate Organi...
ELMED
FDA UDI
ELMED INCORPORATED·00842180102767·BIPOLAR RF-CABLE WITH DAVOL INSTRUMENT CONNECTO...
MAYO SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055353·MAYO SCISSORS CURVED BEVELED TUNGSTEN CARBIDE B...
MIXTER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896061132·MIXTER FORCEPS RIGHT ANGLED LONGITUDINAL SERRAT...
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
FDA 510(k)
FDA Class 2
·General Hospital
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
FDA 510(k)
FDA Class 1
·Ophthalmic
ULTRAFLOW HPC
FDA Adverse Event
Malfunction
·COVIDIEN (IRVINE)·Product code KRA·April 4, 2017
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013
MIRAGE
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code DQX·April 4, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 4, 2017
ULTRAFLOW HCP
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code KRA·April 4, 2017
ONYX
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code MFE·April 4, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 4, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 4, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 4, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 4, 2017
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 27, 2023