14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Multi-parameter Patient Monitor, models C30
FDA 510(k)
FDA Class 2
·Cardiovascular
Accent 1000 Keyguard 4 Location
FDA UDI
PRENTKE ROMICH COMPANY·00858526006385·Keyguards are made from thick, clear polycarbon...
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...
FINGERTIP PULSE OXIMETER, MODEL CMS-50C
FDA 510(k)
FDA Class 2
·Cardiovascular
14 WIRE STANDARD, 14 WIRE LS
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 5, 2021
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 23, 2011
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 23, 2008
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 27, 2018
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 27, 2018
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 27, 2018
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013