31 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Negative Pressure Wound Therapy Device (V-Move, V-Grand)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022606·FPS 2.0mm x 7 Hole Oblique Left T Plate
LEONE SPA
FDA UDI
LEONE SPA·08033707066200·PREFORMED LIGATURE WIRE 009"
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·00678467006738·24-Channel Customized Reusable HRM Esophageal C...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076784·FPS 2.0 7 Hole Oblique Left T Plate Sterile Qty 2
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STAY-PUT IMPREGNATED
FDA 510(k)
FDA Unclassified
·Unknown
ARTICUL/EZE BALL 28 +8.5 BL
FDA Adverse Event
Injury
·DEPUY INTRNATIONAL, LTD.·Product code JDI·November 19, 2008
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·August 17, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·December 26, 2024
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 2025
BELLATEK¿ HYBRID BAR 5 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·February 18, 2025
BELLATEK HYBRID BAR 5 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·March 18, 2025
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 2025
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 2, 2019
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step P in vitro diagnostic test REF: 8194
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026