9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPUTED ORAL RADIOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088651·Paddle Distractor, 17mm
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
FDA 510(k)
FDA Class 2
·Orthopedic
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
FDA 510(k)
FDA Class 2
·Neurology
BAIR HUGGER
FDA Adverse Event
Other
·ARIZANT HEALTHCARE INC.·Product code DWJ·December 14, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
SM104 MSERIES W/5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·December 21, 2012
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 4, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024