14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEU-26L ELCTRONIC ENDODONTIC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809282816574·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015616·microSelectron Transfer Tube for 4F Flexibles (7)
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390869041·
MALLEABLE SHAFT CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069885798·WIDEX MOMENT MRB0 (Mediterranean turquise ) 110...
CLINITEK STATUS
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.·Product code CEM·October 23, 2012
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
VIPER2 X-TAB POLYAXIAL SCREW DRIVER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code LXH·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 23, 2014
LIFEPAK 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 18, 2011
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025