13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIASLIDE URINE CULTURING DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517393388·CoRoent® XL Wide, 10x22x45mm Lordotic
PAQ.210X140X160/QT-HS75/SCHILLER AT-10
FDA UDI
AB MEDICA GROUP, S.A.·08428763009825·
LEONE SPA
FDA UDI
LEONE SPA·08033707059653·DB BRACKET 45 EXTREMO NO-Ni 22 T-22 BH
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869657273·MOSS XT Ti Pedicle Screw Ø10.0x45mm grey, cannu...
ERA IMPLANT
FDA 510(k)
FDA Class 2
·Dental
HUMAN ALBUMIN CSF KIT
FDA 510(k)
FDA Class 2
·Immunology
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
ENDURANT II ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·January 17, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024