11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE
FDA 510(k)
FDA Class 2
·Radiology
Posicast® Thermoplastic
FDA UDI
MEDTEC, INC.·10841439101794·LPR5 Multiperfo mask with profiles
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203412·Interbody, 9mm x 40mm x 14mm, 15 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195427·Interbody, 9mm x 40mm x 14mm, 15 deg
MONITOR CO2 LASER SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
ATA HCM MONOPLACE HYPERBARIC SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 23, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 17, 2014
3.5MM LCP HOOK PLATE 3 HOLE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·February 15, 2019
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020