8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LORENZ IMF SCREW
FDA 510(k)
FDA Class 2
·Dental
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
INVISION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·February 28, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·February 3, 2011
SUPER SUCKER SHORT (BX/20)
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code KDC·December 18, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024