22 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
FDA 510(k)
FDA Class 2
·Cardiovascular
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310214623·FG Diamond 852-016 tree regular 5/pack
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120214621·Carbide, round, bone cutter
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·November 25, 2024
CARESIDE HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
OIL FOR TISSUE CULTURE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 2, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·March 26, 2013
TRAUMA STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 16, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 26, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 31, 2018
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2014
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015