30 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KJ EXTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Bright Tray
FDA UDI
ORMCO CORPORATION·00889989059762·BRIGHT TRAY-LOWER-SIZE 10-PURPLE-PK 20
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003414·33mm 4 Hole EDC Plate
Maxim® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868225130·
MAXIM KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304231641·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031640·
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEGVISION, MODEL EQ1000C SERIES
FDA 510(k)
FDA Class 2
·Neurology
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD220881400510·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD221081400510·10 3/4" Malis Bayonet Bipolar Forceps with Irri...
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2024
PALACOS BONE CEMENT 40GRAM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·November 17, 2017
ACCENT DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·Product code FJI·May 29, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 25, 2011
BIOMET CC CRUCIATE TRAY 67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 13, 2017
MAXIM PRIMARY DCM TIBIAL BEARING 10X63/67 MM WIDE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 21, 2017
MAX PRI DCM TIB BRNG12X71/75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 26, 2019
BIOMET ACROM PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 13, 2017