34 results · 23ms · Sources: EU EUDAMED, 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