21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040114544·HP Intraoral Tips Yellow Small
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292947·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049323·K-Wires, Double diamond, .045-inch (1.1mm) diam...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484498·K-Wire w. double end lanzet point _x000D_...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189923·TAPERED TIBIAL TRAY DRILL
K-Wire w. double end lanzet point 1.1mm/102mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712020·K-Wire w. double end lanzet point
1.1mm/...
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WALPEO TABLH
FDA 510(k)
FDA Class 1
·Physical Medicine
IBALANCE TKA TIBIAL TRAY SIZE 5
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code JWH·September 5, 2019
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 1, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·January 26, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 8, 2014
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016