12 results
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25ms
·
Sources: EU EUDAMED, US FDA
2M8101 HEATED LIQUID LEVEL CONTROLLER
FDA 510(k)
FDA Class 2
·Anesthesiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111321610·BRINCKERHOFF RECTAL SPEC LARGE
ACUMED
FDA UDI
Acumed LLC·10806378095528·Post-Lat Distal Humerus T-Guide R
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
AMICAS PACS, VERSION 6.0
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013
ENDOPORE ABUTMENT
FDA Adverse Event
Injury
·SYBRON IMPLANT SOLUTIONS·Product code NHA·August 17, 2010
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024