14 results
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20ms
·
Sources: EU EUDAMED, US FDA
CREATINE KINASE (CK) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
38mm x 30mm x 8° ALIF Rasp Kit 11, 13, 15, 17mm Heights
FDA UDI
XENCO MEDICAL LLC·B064XM38812371·
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308514·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308774·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308408·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308644·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
Glidesheath Slender Tibial Pedal Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
FDA 510(k)
FDA Class 1
·Dental
PORTEX TRACHEAL TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD·Product code BTR·February 14, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 6, 2010
ETAC SWIFT MOBIL
FDA Adverse Event
Malfunction
·ETAC SUPPLY CENTER AB·Product code INM·November 12, 2012
NUT FOR INTERLOCKING BOLTS FOR PERCUTANEOUS INSERTION HANDLE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·May 4, 2020
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020