15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATTUNE Cemented Tibial Base, Fixed Bearing
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103111·7.0 x 105mm Cann Hdless Screw, 32mm Thd
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197074834·RIGBY retract., rectum, vagina
OsteoMed
FDA UDI
OSTEOMED LLC·00842528107478·7.0 x 105mm Hdls Screw 32Thd Sterile 2Pk
COMFORT TOUCH INSUIN PEN NEEDLES
FDA Adverse Event
Malfunction
·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 2, 2020
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 15, 2020
ULTRASONIC DISSECTOR QTY OF 6
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code LFL·May 22, 2013
VISTEC SPG 4X4 STR 10S 16 PLY
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GDY·June 22, 2011
LARGE NEEDLE DRVIER ISNTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GCJ·September 12, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024