The products listed in this section include some of the newest medical technology from the year 2021. 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 2021
Device Name
Category
Date
Organ Care System (OCS) Heart System - P180051
Transplant
09/03/2021
Vercise™ PC, Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) System - P150031/S040
Implant
10/20/2021
Spatz3 Adjustable Balloon System - P190012
Implant
10/15/2021
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026
Laboratory Test
10/12/2021
ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters - P200004
Defibrillator Components
09/26/2021
Organ Care System (OCS) Liver - P200031
Portable Enclosure
09/28/2021
Portico Transcatheter Aortic Valve Implantation System - P190023
Implant
09/17/2021
therascreen KRAS RGQ PCR Kit - P110027/S012
Laboratory Test
09/09/2021
RADIESSE (+) Lidocaine Injectable Implant - P050052/S129
Dermal Filler
09/01/2021
ASSURE Wearable Cardioverter Defibrillator System Kit (P/N 80014-001), Monitor (P/N 80008-003), Therapy Cable (P/N 80004-003), Garment Style A (P/N 80015-XXX*) and Style B (P/N 80016-XXX*), Rechargeable Battery (P/N 3322882-005), Carry Pack (3326503-003), Battery Charger (3326633-004), Tablet (P/N 80041-001) - P200037
Defibrillator
08/26/2021
Oncomine Dx Target Test - P160045/S028
Laboratory Test
08/25/2021
VENTANA MMR RxDx Panel - P210001
Laboratory Test
08/17/2021
Amplatzer Amulet Left Atrial Appendage Occluder - P200049
Implant
08/14/2021
RelayPro Thoracic Stent-Graft System - P200045
Stent System
08/05/2021
Senza Spinal Cord Stimulation System - P130022/S039
Implant
07/16/2021
FoundationOne Liquid CDx - P190032/S001
Laboratory Test
07/15/2021
Centaur Anti-HBe2 - P200017
Laboratory Test
07/14/2021
Restylane® Contour - P140029/S032
Gel Implant
06/28/2021
XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), XIENCE Skypoint Everolimus Eluting Coronary Stent Systems (XIENCE Skypoint EECSS) - P110019/S115
Stent System
06/25/2021
Neuro Cochlear Implant System - P200021
Implant
06/23/2021
The Arctic Front Advance and Arctic Front Advance Pro and The Freezor MAX Cardiac Cryoablation Catheters - P100010/S110
Catheter
06/18/2021
Guardant360 CDx - P200010/S002
Laboratory Test
05/28/2021
JUVÉDERM® VOLBELLA® XC - P110033/S053
Gel Implant
05/28/2021
Guardant360 CDx - P200010/S001
Laboratory Test
05/21/2021
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S125
Heart Valve
05/13/2021
TECNIS Synergy™ Intraocular Lens (IOL) (Model ZFR00V), TECNIS Synergy™ Toric II IOL (Models ZFW150, ZFW225, ZFW300, ZFW375), TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System (Model DFR00V), TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System (Models DFW150, DFW225, DFW300, DFW375) - P980040/S124
Intraocular Lens (IOL)
04/28/2021
EPi-Sense® Guided Coagulation System - P200002
Guided Coagulation System
04/28/2021
VENTANA MMR RxDx Panel - P200019
Laboratory Test
04/22/2021
Simplify® Cervical Artificial Disc - P200022/S003
Implant
04/01/2021
Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System - P200046
Catheter
03/26/2021
ClearVisc Ophthalmic Viscosurgical Device - P200025
Ophthalmic Device
03/23/2021
TheraSphere™ - P200029
Radiation Treatment
03/17/2021
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBsCalCheck - P190034
Laboratory Test
02/23/2021
Patient Specific Talus Spacer - H200001
Implant
02/17/2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter - P200039
Catheter
02/12/2021
Senza Spinal Cord Stimulation System - P130022/S039
Implant
07/16/2021
FoundationOne Liquid CDx - P190032/S001
Laboratory Test
07/15/2021
Centaur Anti-HBe2 - P200017
Laboratory Test
07/14/2021
Restylane® Contour - P140029/S032
Gel Implant
06/28/2021
XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), XIENCE Skypoint Everolimus Eluting Coronary Stent Systems (XIENCE Skypoint EECSS) - P110019/S115
Stent System
06/25/2021
Neuro Cochlear Implant System - P200021
Implant
08/25/2021
Content current as of:
12/20/2021
Regulated Product(s)
Topic(s)