73 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047371·TC Potts-Smith Forceps
180mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047418·TC Potts-Smith Forceps
250mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047395·TC Potts-Smith Forceps
210mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047364·TC Potts-Smith Forceps
150mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047401·TC Potts-Smith Forceps
230mm,...
CONSENSUS REVISION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GENSTRIP TEST STRIP MODEL 100-201
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CELL-DYN 1800 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 16, 2015
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 17, 2019
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
LIKORALL
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·March 26, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 14, 2011
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025