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