13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERFORMAX PEDIATRIC SE TOTAL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018227·Wide Jaw Punch small 3.5mm 7 degree up
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
SL3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
FDA 510(k)
FDA Class 2
·Physical Medicine
ALLERGY SYRINGE WITH BD PRECISIONGLIDE PERMANENTLY ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 17, 2020
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 20, 2013
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·September 26, 2014
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 10, 2011
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·December 26, 2012
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code HBL·November 5, 2012
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017