41 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVERCROSS 0.035 OTW PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Smith & Nephew, Inc.·03596010034960·HIBBS OSTEOTOME STRAIGHT 31.7MM
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176162816·Bone cutter HP 1,6 mm, pu: 1 St.
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811500·Volkman 6 Prong Retractor, Blunt, 21.5cm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450201251·
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMULISA DSDNA ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 7, 2025
MR850
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 11, 2026
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·September 22, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 6, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 10, 2024
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 4, 2025
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 19, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 10, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·Product code BTT·February 18, 2021
MR850
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·March 26, 2026
VUE PACS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
ADVANCE(R) TOT COND FEMORAL PC
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JWH·September 23, 2014