34 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ProMIS Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699526·GENUMEDI PSS BLUE, SIZE O
Oticon
FDA UDI
Oticon A/S·05707131287700·H10V2, RITE 312 WL TC
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239081·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100103·BARRAQUER SPECULUM SOLID LARGE
TiLock
FDA UDI
Genesys Orthopedics Systems LLC·M719G1503800·Pre-Bent Rod
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104408·NEATCUT BLADE, 4.5MM, COMPATIBLE W/SN
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
FDA 510(k)
FDA Class 2
·Anesthesiology
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
FDA 510(k)
FDA Class 2
·Radiology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102411·DISPOSABLE ARTHROSCOPIC 4.5mm NEATCUT SHAVER BL...
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 7, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 19, 2023
BD PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·February 12, 2026
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 6, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 7, 2011
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 17, 2021
MICRUSFRAME10 5MM X 17CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022