14 results
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19ms
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Sources: EU EUDAMED, US FDA
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575262700·Modular Stem, Cylindrical Press-Fit
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575262793·Modular Stem, Cylindrical Press-Fit
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575262786·Modular Stem, Cylindrical Press-Fit
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575262809·Modular Stem, Cylindrical Press-Fit
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575262540·Modular Stem, Cylindrical Press-Fit
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575262564·Modular Stem, Cylindrical Press-Fit
Rodo Smilekey
FDA 510(k)
FDA Class 2
·Dental
SWC/DWC WARMING CABINETS
FDA 510(k)
FDA Class 1
·Physical Medicine
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·October 22, 2010
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·December 19, 2012
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017