11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vantage Orian 1.5T, MRT-1550, V6.0
FDA 510(k)
FDA Class 2
·Radiology
ECHO BI-METRIC MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304697881·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm
9.3MHZ PENCIL PROBE 841-A
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787021547·
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATLANTIS SLIT LAMP
FDA 510(k)
FDA Class 2
·Ophthalmic
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 13, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 5, 2011
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023