19 results · 35ms · Sources: EU EUDAMED, US FDA

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EVOS Lumbar Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I

HHM

FDA UDI
Oticon A/S·05707131286734·H100V2, MINIRITE 312 WL SGR HHM

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819995·Marina Dissector, S-Shaped Shaft, 24cm

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613154020126·Posterior Stabilized Tibial Insert

PLASTIPAK LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 22, 2025

ONTRAK TESTCARD 9

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

FDA 510(k)
FDA Class 2 ·Immunology

BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2025

BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2025

BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

TI 3-D HEAD FOR TI CLICK X SCREWS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·June 6, 2013

SGL TRIG WIRE COLLET 0.7-1.8MM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 7, 2011

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 21, 2022

OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 21, 2022