22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U2 FEMORAL COMPONENT, CR, CEMENTED
FDA 510(k)
FDA Class 2
·Orthopedic
Embla
FDA UDI
S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817280·
MAXIM KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304007307·
MAXIM® KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225215·
CAPTURED SCREW ASSEMBLY
FDA UDI
Biomet Orthopedics, LLC·00887868003967·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031763·
TRULINK
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101052·NIBP,CUFF,1TB,ADULT-LONG,23-33CM,NYLON,1/EA
INFX-8000V WITH
FDA 510(k)
FDA Class 2
·Radiology
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
FDA 510(k)
FDA Class 2
·Hematology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
Widex
FDA UDI
Widex A/S·05706069564297·Widex UNIQUE U-FP (Titan grey ) 440, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069553826·Widex UNIQUE U-FA (Titan grey ) 440, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069556513·Widex D-FA P (Titan grey ) Dream 440, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069575804·Widex UNIQUE U-FM (Titan grey ) 440, RC coil
MAXIM PRIMARY TIBIAL BEARING 12MM X 71/75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 25, 2022
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83MM WIDE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 11, 2017
UNKNOWN MESH PRODUCT (EWHU)
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 31, 2013
SYNCHRON LX® RHEUMATOID FACTOR REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011
GORE-TEX VASCULAR GRAFT
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·August 29, 2008