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
RHA Redensity – P170002/S012
Dermal Filler
12/22/2021
SCOREFLEX NC SCORING PTCA CATHETER – P200041
Catheter
12/21/2021
SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System – P210014
Stent Delivery System
12/13/2021
OrganOx metra® System - P200035
Donor Liver Transport System
12/09/2021
SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly – P200040
Ultrasound
10/06/2021
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) – P150038/S014
Ultrasound
10/29/2021
Oncomine Dx Target Test – P160045/S029
Laboratory Test
09/15/2021
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
VENTANA PD-L1 (SP263) Assay – P160046/S010
Laboratory Test
10/15/2021
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
05/28/2021
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
07/27/2021
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
Dermal Filler
12/22/2021
SCOREFLEX NC SCORING PTCA CATHETER – P200041
Catheter
12/21/2021
SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System – P210014
Stent Delivery System
12/13/2021
OrganOx metra® System - P200035
Donor Liver Transport System
12/09/2021
SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly – P200040
Ultrasound
10/06/2021
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) – P150038/S014
Ultrasound
10/29/2021
Oncomine Dx Target Test – P160045/S029
Laboratory Test
09/15/2021
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
VENTANA PD-L1 (SP263) Assay – P160046/S010
Laboratory Test
10/15/2021
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
05/28/2021
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
07/27/2021
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
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
4Kscore Test – P190022
Laboratory Test
12/07/2021
Optilume® Urethral Drug Coated Balloon – P210020
Drug Coated Balloon
12/03/2021
Content current as of:
01/19/2022
Regulated Product(s)
Topic(s)