19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fully Automatic Electronic Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741514600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674151460060·
CoRoent
FDA UDI
Nuvasive, Inc.·00887517232274·CoRoent XLW 15°, 14x22x60mm
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087968·
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962101889·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10m...
LOCI 8 CALIBRATOR, MODEL KC 646
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C.CAM-AC
FDA 510(k)
FDA Class 2
·Radiology
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962104095·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10m...
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·May 5, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
PLM A+ PLATINUM MODU
FDA Adverse Event
Malfunction
·HSOPIRA COSTA RICA LTD·Product code FRN·May 30, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 6, 2011
DEPTH GAUGE FOR LARGE SCREWS
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTJ·May 5, 2015
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HTJ·May 5, 2015
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·May 5, 2015
DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HTJ·May 5, 2015
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·October 3, 2018
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024