21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ODFS Pace XL
FDA 510(k)
FDA Class 2
·Neurology
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·August 27, 2025
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·April 6, 2018
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·March 8, 2022
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
FDA 510(k)
FDA Class 2
·Radiology
DYNAFLEX
FDA 510(k)
FDA Class 2
·Dental
MUST MINI ROD TI 3.5 X 80MM (STERILE)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018
MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 14, 2020
Z-LOOK3
FDA Adverse Event
Injury
·Z-SYSTEMS AG·Product code DZE·June 15, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·June 30, 2011
FLEXIMA BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 17, 2008
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FCG·December 26, 2017
MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·October 27, 2022
MUST MINI ROD REDUCTION DEVICE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·September 27, 2019
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·August 11, 2025
MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018