22 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
FDA 510(k)
FDA Class 2
·General Hospital
Orthos
FDA UDI
ORMCO CORPORATION·00889989030259·ORTHOS CM TMA 017 X 025 UPSM PK10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198499·AK3 Ultra Insert Trial Size 2, 10mm
Aspida
FDA UDI
ALPHATEC SPINE, INC.·00840967190983·SACRAL DTS GUIDE 10MM
43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·March 16, 2024
43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·March 16, 2024
43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·March 18, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 29, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 29, 2024
FRAXION
FDA 510(k)
FDA Class 2
·Radiology
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EXPERIENCE
FDA UDI
Gc Orthodontics America Inc.·D78819221000071·Exp CCO RH 022/UL1 12T 5A
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819221000101·EXMRC ROTH 022/UL1 12T 5A
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819221000201·EXMRC MBT 022/UL1 17T 4A
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107972·TRIAL 90-SRK-192210 POLY-MPCS 2X10 LEFT
43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·March 21, 2024
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
ARROW
FDA Adverse Event
Injury
·ARROW INTERNATIONAL, INC.·Product code CAZ·October 8, 2008
PLUM XLM W/ DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 20, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011