17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zenostar MT, Zenostar Color Liquids
FDA 510(k)
FDA Class 2
·Dental
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502307·INTERBODY 2152118 SMALL - 12 DEG 18MM
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283679·MEYERDING FINGER RETRACTOR #2 7"
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 9, 2002
DOSE VERIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SNORE GUARD ADVANCE
FDA 510(k)
FDA Class 2
·Dental
U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022
U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022
31G X 8 MM PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·May 7, 2010
U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023
LINOX S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·October 8, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 24, 2013
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·November 7, 2019
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024