30 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4K UHD Camera System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694011006·Compression Plate Drill Guide, 2.0mm
FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060579·FORCEPS TUNGSTEN CARBIDE DUST PLATFORM RING TIP...
OPERATING SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054561·OPERATING SCISSORS STRAIGHT SHARP TIPS POWER CU...
uCT 530, uCT 550
FDA 510(k)
FDA Class 2
·Radiology
PSK ENDOSCOPE CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 5, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 14, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 21, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 10, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 13, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 13, 2017
EMBLEM MRI S-ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 18, 2024
EMBLEM S-ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 18, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
THERASPHERE
FDA Adverse Event
Death
·MDS NORDION·Product code KXK·April 16, 2003
IPUMP PAIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE (SG)·Product code MEA·November 12, 2002
BIOGLUE SURGICAL ADHESIVE
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MUQ·August 11, 2011
ON-Q C-BLOC
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·October 1, 2008
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 1, 2013