14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HELICOBACTER PYLORI ELISA IGG TEST KIT
FDA 510(k)
FDA Class 1
·Microbiology
ADVIA Centaur® FER
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177144·Ferritin - CENTAUR - RGT - 50 tests
Leva® Anterior Expandable Spacer System
FDA UDI
Spine Wave, Inc.·10840642109276·Spacer, 34 mm (W) x 30 mm (D) x 15 mm (H), 8° L...
Zavation
FDA UDI
Zavation LLC·00842166181427·4.5mm Cannullated Tap
EMS 3000
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·September 23, 2014
UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 2, 2011
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 20, 2026
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024