|
|
522 Order Number |
|
|
|
Manufacturer |
|
|
|
Device Name |
|
|
|
Medical Specialty |
|
|
|
Date 522 Order |
|
|
|
|
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 |
PS200001
|
Avenu Medical, Inc. |
Ellipsys vascular access system |
Cardiovascular |
01/10/2020 |
Ellipsys Vascular Access System Postmarket Study
|
Ongoing |
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
|
Study Pending |
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 |
PS230003
|
Empower Medical Devices |
Breast Implant Removal Device (BIRD) previously the Bateman Bottle |
General & Plastic Surgery |
06/20/2023 |
Bateman Bottle Postmarket Surveillance Study
|
Study Pending |
PS230001
|
Happiest Baby, Inc. |
Snoo smart sleeper |
General Hospital |
03/30/2023 |
SNOO Smart Sleeper
|
Ongoing |
PS220002
|
Insulet Corporation |
Insulet smartadjust |
Clinical Chemistry |
12/21/2022 |
SmartAdjust Technology
|
Ongoing |
PS230004
|
Laminate Medical Technologies, Ltd. |
Vasq |
Cardiovascular |
09/26/2023 |
VasQ Postmarket Surveillance Study
|
Study Pending |
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
|
Delayed |
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
|
Ongoing |
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 |
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 |
PS190001
|
Rapid-Medical, Ltd. |
Comaneci embolization assist device |
Neurology |
05/22/2019 |
Success in Comaneci-Assist Coils Embolization Surv
|
Ongoing |
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 |