19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESCAN
FDA 510(k)
FDA Class 2
·Anesthesiology
Maxim® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868225161·
MAXIM KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304011182·
Bright Tray
FDA UDI
ORMCO CORPORATION·00889989059793·BRIGHT TRAY-LOWER-SIZE 16-GREEN-PK 20
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031664·
Merit® Kit
FDA UDI
Merit Medical Systems, Inc.·00884450256398·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD221081400540·10 3/4" Malis Bayonet Bipolar Forceps with Irri...
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD220881400540·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
FDA 510(k)
FDA Class 2
·Neurology
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
FDA 510(k)
FDA Class 1
·General Hospital
MAX PRI TIB BRNG 14X79/83
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 1, 2019
OPTISENSE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·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
MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83 MM WIDE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 2, 2017
RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013