522 Postmarket Surveillance Studies Database

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Study Name

Study Status

PS210001 Abbott Diabetes Care Inc. Freestyle libre 2 flash glucose monitoring system Clinical Chemistry 02/18/2021 Postmarket Surveillance Delayed PS140001 Argo Medical Technologies, Inc Rewalk Neurology 06/26/2014 ReWalk Registry Redesigned/Replaced Study PS160001 Bayer Healthcare, LLC Essure system for permanent birth control Obstetrics/
Gynecology 02/29/2016 Postmarket Surveillance Study Ongoing PS240001 Beta Bionics, Inc. Ilet dosing decision software Clinical Chemistry 03/04/2024 iLet Postmarket Surveillance Study Ongoing PS200005 Caldera Medical, Inc. Desara one single incision sling system Gastroenterology/
Urology 02/11/2020 Postmarket Surveillance Study Delayed PS220001 Canary Medical, Inc. Canary tibial extension (cte) w/canary health implanted reporting processor (chirp) system Orthopedic 01/24/2022 Study of Subjects with the CTE Delayed PS250004 Deka Research and Development Deka loop Clinical Chemistry 05/01/2025 DEKA Loop Postmarket Surveillance Study Study Pending PS230003 Empower Medical Devices Breast Implant Removal Device (BIRD) previously the Bateman Bottle General &
Plastic Surgery 06/20/2023 Bateman Bottle Postmarket Surveillance Study Noncompliant PS230001 Happiest Baby, Inc. Snoo smart sleeper General Hospital 03/30/2023 SNOO Smart Sleeper Delayed PS220002 Insulet Corporation Insulet smartadjust Clinical Chemistry 12/21/2022 SmartAdjust Technology Delayed PS230004 Laminate Medical Technologies, Ltd. Vasq Cardiovascular 09/26/2023 VasQ Postmarket Surveillance Study Ongoing PS200006 Medtronic, Inc. Carpediem Gastroenterology/
Urology 04/29/2020 CARPEDIEM 522 Delayed PS200004 Merit Medical Systems, Inc. Surfacer inside-out access catheter system Cardiovascular 02/10/2020 Surfacer Postmarket Surveillance Study Ongoing PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal Ion Levels Wright Redesigned/Replaced Study PS230002 Moximed, Inc. Misha knee system Orthopedic 06/06/2023 MISHA Post-Market Clinical Study Delayed PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 Registry Database Redesigned/Replaced Study TMJM Registry Study - Partial Redesigned/Replaced Study Prospective Postmarket Surveillance Study Plan Progress Inadequate Explant Analysis Study Plan Progress Adequate PS200003 Olympus America, Inc. Evis exera iii duodenovideoscope tjf-q190v Gastroenterology/
Urology 01/17/2020 Sampling and Culturing Study Delayed PS240012 Onkos Surgical, Inc. EleosTM limb salvage system with nanoceptTM technology (previously eleosxTM limb salvage system) Orthopedic 10/17/2024 ELEOS Post-Market Clinical Study Study Pending PS210002 Pentax Pentax ed32-i10 duodenoscope Gastroenterology/
Urology 04/01/2021 Postmarket Surveillance (PS) Study Delayed PS190005 Pentax of America, Inc. Pentax duodenoscope model ed34-il0t2 Gastroenterology/
Urology 11/15/2019 Sampling and Culturing Study Delayed PS230005 Tandem Diabetes Co. Control-iq technology Clinical Chemistry 11/03/2023 Postmarket Surveillance Study Ongoing PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental 02/04/2011 Time to Revision and Explant Analysis Progress Adequate PS180002 TVA Medical, Inc. WavelinQ EndoAVF System Cardiovascular 06/22/2018 WavelinQ EndoAVF Delayed