15 results
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18ms
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Sources: EU EUDAMED, US FDA
SM ANTIBODY TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
MEDICOM SAFESEAL QUATTRO
FDA UDI
AMD Medicom Inc·10686864045783·SAFESEAL QUATTRO 5 1/4 X 10 IN
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255894·Articulating Surfaces, PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255924·Articulating Surfaces, PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255917·Articulating Surfaces, PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255931·Articulating Surfaces, PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255870·Articulating Surfaces, PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255900·Articulating Surfaces, PS
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
DENTURE CLEANSER & TOOTHPASTE IN ONE
FDA 510(k)
FDA Class 1
·Dental
OCTRODE PERCUTANEOUS LEADS
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 19, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014
EQUIPMENT MANAGEMENT SYSTEM
FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code FQO·December 19, 2012
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL 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