11 results
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27ms
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Sources: EU EUDAMED, US FDA
MRX-865
FDA 510(k)
FDA Class 1
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
Tronex International, Inc.
FDA UDI
TRONEX INTERNATIONAL, INC.·10097604921135·Glove, Exam, Nitrile, Fingertip-Textured, Powde...
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
FDA 510(k)
FDA Class 2
·Orthopedic
SPECATH CENTRAL VENOUS CATHETER KITS
FDA 510(k)
FDA Class 2
·General Hospital
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2015
SENSIA SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·December 13, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 9, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024