106 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Nano 2nd Gen Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958002090·Medilas D30 1064 Diode Laser, SMA
MEGA5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228125715·Rod, Ø5.5 x 150mm
Thino Roth Bracket, .022 Mini, UL5, w/o hook
FDA UDI
Astar Orthodontics Inc.·06941673501514·
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100685·EVOS Straight HA PEEK, 15mm x 8mm x 22mm, Flat ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable
PREMIER HB9210 HBA1C ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN DEPUY STEM
FDA Adverse Event
Injury
·OCT 21, 2015·Product code JDG·November 6, 2015
GYNECARE GYNEMESH PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 20, 2011
UNKNOWN COOL TIP ELECRTRODE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·March 4, 2020
UNKNOWN COOL TIP ELECRTRODE
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·March 4, 2020
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 8, 2013
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·December 28, 2017
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016