9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155978·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 230mm
Arthrex Self-Punching PushLock Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
REX, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
SENSIA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·January 17, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·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 GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024