The products listed in this section include some of the newest medical technology from the year 2019. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.
Medical Devices Cleared or Approved by FDA in 2019
Device Name
Category
Date
CentriMag Circulatory Support System - P170038
Blood Pump
12/06/19
FoundationOne®CDx - P170019/S006
Laboratory Test
12/03/19
LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047
Laboratory Test
11/26/19
Tula® System - P190016
Ear Tubes
11/25/19
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter - P190008
Balloon Catheter
11/21/19
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear – P180035
Contact Lenses
11/15/19
Axonics Sacral Neuromodulation (SNM) System for Urinary Control – P180046
Urinary Retention
11/13/19
Myriad myChoice CDx - P190014
Laboratory Test
11/07/19
LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab - P190011
Laboratory Test
10/18/19
iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems – P930016/S057
Laser Vision Correction
09/09/19
Axonics Sacral Neuromodulation (SNM) System - P190006
Incontinence
09/06/19
Alcon Laboratories, Inc. AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) - P040020/S087
Intraocular Lens
08/26/19
Minimally Invasive Deformity Correction (MID-C) System - H170001
Spine
08/23/19
BAROSTIM NEO System - P180050
Heart Failure
08/16/19
The Tether™ - Vertebral Body Tethering System - H190005
Spine
08/16/19
Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058
Heart Valve
08/16/19
Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085
Heart Valve
08/16/19
PD-L1 IHC 22C3 pharmDx - P150013/S016
Laboratory Test
07/30/19
MED-EL Cochlear Implant System - P000025/S104
Cochlear Implant
07/19/19
Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033
Heart Valve
07/10/19
PD-L1 IHC 22C3 pharmDx - P150013/S014
Laboratory Test
06/10/19
HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) - P160029
Defibrillator
06/06/19
Eversense Continuous Glucose Monitoring System - P160048/S006
Glucose Monitor
06/06/19
Hintermann Series H3™ Total Ankle Replacement System - P160036
Joint Replacement
06/04/19
TransMedics OCS Lung System - P160013/S002
Lung Donor
05/31/19
The therascreen PIK3CA RGQ PCR Kit - P190001 and P190004
Cancer
05/24/19
NovoTTF™-100L System - H180002
Cancer
05/23/19
Neuroform Atlas® Stent System - P180031
Stent
05/16/19
VICI VENOUS STENT® System - P180013
Stent
05/02/19
Tack Endovascular System® (6F) - P180034
Vascular
05/01/19
XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014
Perfusion System
04/26/19
LOTUS Edge™ Valve System - P180029
Heart Valve
04/23/19
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024
Weight Loss
04/16/19
therascreen ® FGFR RGQ PCR Kit – P180043
Laboratory Test
04/12/19
TherOx DownStream System - P170027
Oxygen Therapy
04/02/19
Cerene Cryotherapy Device - P180032
Menstrual Bleeding
03/28/19
TRILURON™ - P180040
Osteoarthritis
03/16/19
OPTIMIZER Smart System - P180036
Cardiovascular
03/21/19
MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028
Vascular
03/14/19
VENOVO Venous Stent System - P180037
Stent
03/13/19
Barricaid® Anular Closure Device (ACD) - P160050
Cancer
03/11/19
COVERA™ Vascular Covered Stent - P170042/S002
Stent
03/01/19
VENTANA PD-L1 (SP142) Assay - P160002/S009
Hernia
02/08/19
M6-C™ Artificial Cervical Disc - P170036
Spine
02/06/19
MANTA Vascular Closure Device - P180025
Vascular
02/01/19
Sangia Total PSA Test - P170037
Prostate Cancer
01/30/19
Content current as of:
02/11/2020