75 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CovaWound Alginate Ag 2x30cm
FDA UDI
Covalon Technologies Ltd·00825439012208·Alginate dressing with silver
COR-VASC System with articulated arm (Small)
FDA UDI
Coroneo Inc·10817121000522·The COR-VASC system is intended to be used for ...
OPERATING SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046702·OPERATING SCISSORS CURVED BLUNT BLADES
COOLEY MULTI PURPOSE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002300·COOLEY MULTI PURPOSE CLAMP ANGLED
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776304201·Doyen scissors, 7" straight
OsteoMed
FDA UDI
OSTEOMED LLC·00845694001809·24mm 4 Hole Straight Rigid Plate
COOLEY MULTI PURPOSE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896010178·COOLEY MULTI PURPOSE CLAMP ANGLED
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037309155·HUMERAL STEM AXIS
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCLAIM ENCORE
FDA Adverse Event
Other
·ABBOTT LABORATORIES·Product code FRN·September 17, 1999
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 3, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 1, 2021
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·June 21, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 3, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 1, 2022
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 22, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 15, 2022