23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINIFIX BALL MINIFIX ONE
FDA 510(k)
FDA Class 2
·Dental
ArgenZ HT+ 98x18 OM2
FDA UDI
ARGEN CORPORATION, THE·D818122052·Dental porcelain/ceramic restoration kit
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981029661·CONTOURED CROSSBAR, MEDIUM, 5.5 ROD
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973134·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970461·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970454·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973615·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973608·
Logical PX-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000387·
CAREFUSION NICOLET EDX
FDA 510(k)
FDA Class 2
·Neurology
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
THERMAL SENSORY ANALYZER (TSA-II)
FDA Adverse Event
Injury
·MEDOC LTD., ADVANCED MEDICAL SURGERY MEDISCENSE USA·Product code LQW·December 26, 2019
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 21, 2013
ENTRUST VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code KNW·August 14, 2008
CONTOURED CROSSBAR MEDIUM 5.5 ROD
FDA Adverse Event
Other
·SEASPINE, INC.·Product code NKB·August 28, 2014
QSENSE CPM THERMAL SENSORY ANALYZER 2001
FDA Adverse Event
Malfunction
·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022
REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 19, 2021
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021