Medical Device Clearances & Approvals
Authoritative tracking of FDA 510(k), PMA, De Novo decisions, and digital health technology.
Last Synced: 2026-11-14 19:22 UTC
Indexed Devices
297
✦ AI/ML Enabled
4
New Devices
162
Modifications
135
| Submission ID | Determination | Lifecycle | AI/ML | Device Name & Code | Applicant & Market Status | Decision Date | Review Speed | Action |
|---|---|---|---|---|---|---|---|---|
| P810031 | APPROVED | MOD | -- |
Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hya
Code: LZP
• Ophthalmic
|
Johnson & Johnson Surgical Vision, Inc.
↳ JNJ
|
2026-10-30 | 95d | |
| P250025 | APPROVED | MOD | -- |
TorEx Lung Perfusion System; TorEx Lung Perfusate
Code: PHO
• Gastroenterology, Urology
|
Traferox Technologies, Inc.
PRIV
|
2026-10-30 | 84d | |
| P190018 | APPROVED | MOD | -- |
Clareon Vivity Pro Extended Vision IOLs
Code: POE
• Ophthalmic
|
Alcon Laboratories, LLC
↳ ALC
|
2026-10-30 | 169d | |
| P170038 | APPROVED | MOD | -- |
CentriMag Circulatory Support System
Code: DSQ
• Cardiovascular
|
Abbott
↳ ABT
|
2026-10-30 | 30d | |
| P150006 | APPROVED | MOD | -- |
CELT ACD VASCULAR CLOSURE DEVICE
Code: MGB
• Cardiovascular
|
Vasorum, Ltd.
PRIV
|
2026-10-30 | 28d | |
| K263860 | CLEARED | NEW | -- |
Shining3D Clear Aligner System
Code: NXC
• Dental
|
Hangzhou SHINING3D Dental Technology Co., Ltd.
PRIV
|
2026-10-30 | 1d | |
| K263592 | CLEARED | MOD | -- |
da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)
Code: NAY
• Gastroenterology, Urology
|
Intuitive Surgical, Inc.
ISRG
|
2026-10-30 | 30d | |
| K263587 | CLEARED | MOD | -- |
Arctic Sun Neonatal ArcticGel Pad
Code: DWJ
• Cardiovascular
|
Medivance, Inc.
PRIV
|
2026-10-30 | 30d | |
| K263232 | CLEARED | NEW | -- |
eplex RP3 Control M530; eplex RP3 Negative
Code: PMN
• Microbiology
|
Maine Molecular Quality Controls, Inc.
PRIV
|
2026-10-30 | 44d | |
| K263109 | CLEARED | NEW | AI |
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Code: QAS
• Radiology
|
Ever Fortune.Ai, Co., Ltd.
PRIV
|
2026-10-30 | 56d | |
| K263076 | CLEARED | NEW | -- |
AngioVac F1885
Code: DWF
• Cardiovascular
|
AngioDynamics, Inc.
ANGO
|
2026-10-30 | 59d | |
| K263075 | CLEARED | NEW | -- |
Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
Code: FAJ
• Gastroenterology, Urology
|
Strauss Surgical USA
PRIV
|
2026-10-30 | 58d | |
| K263063 | CLEARED | NEW | -- |
B`orze Inc Laser Family (Sorren/Adonis)
Code: GEX
• General, Plastic Surgery
|
Borze, Inc.
PRIV
|
2026-10-30 | 59d | |
| K262971 | CLEARED | NEW | -- |
Xpert® Hemorrhagic Fever Panel
Code: QVR
• Immunology
|
Cepheid
PRIV
|
2026-10-30 | 65d | |
| K262938 | CLEARED | NEW | -- |
cobas eplex respiratory pathogen panel 3
Code: QOF
• Microbiology
|
GenMark Diagnostics, Inc.
PRIV
|
2026-10-30 | 70d | |
| K262816 | CLEARED | NEW | -- |
EXG PulseLinQ Cables (EXGPL)
Code: DSA
• Cardiovascular
|
Cb Innovations, LLC
PRIV
|
2026-10-30 | 84d | |
| K262685 | CLEARED | NEW | -- |
Zirconia Collective 4Y Dental Zirconia Blank
Code: EIH
• Dental
|
Zirconia Collective, Inc.
PRIV
|
2026-10-30 | 91d | |
| K262470 | CLEARED | NEW | -- |
Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)
Code: NGX
• Physical Medicine
|
Changsha Anxiang Medical Technology Co., Ltd.
PRIV
|
2026-10-30 | 105d | |
| K262066 | CLEARED | NEW | -- |
Pleiades Device
Code: MQK
• Obstetrics/Gynecology
|
My123Baby Medical Limited Dba Boost Fertility
PRIV
|
2026-10-30 | 130d | |
| K261886 | CLEARED | MOD | -- |
VIVO (9002)
Code: DQK
• Cardiovascular
|
Catheter Precision, Inc.
VIVO
|
2026-10-30 | 147d | |
| K261072 | CLEARED | NEW | -- |
DS Core Detect
Code: MYN
• Radiology
|
Dentsply Sirona, Inc.
XRAY
|
2026-10-30 | 212d | |
| K260738 | CLEARED | MOD | -- |
Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
Code: NBW
• Clinical Chemistry
|
Changsha Sinocare, Inc.
PRIV
|
2026-10-30 | 238d | |
| K260648 | CLEARED | NEW | -- |
PolySense
Code: GWL
• Neurology
|
Itamar Medical , Ltd.
PRIV
|
2026-10-30 | 245d | |
| K260575 | CLEARED | NEW | -- |
AutoGel Pad (400-046,400-005)
Code: MUI
• Radiology
|
Top-Rank Health Care Co., Ltd.
PRIV
|
2026-10-30 | 252d | |
| K260360 | CLEARED | NEW | -- |
AesyBite Active
Code: HCC
• Neurology
|
Aesyra SA
PRIV
|
2026-10-30 | 268d | |
| K260354 | CLEARED | NEW | -- |
Foster Plus-22L (SNK/CE-F22)
Code: FLE
• General Hospital
|
Zhejiang Fomos Medical Technology Co., Ltd.
PRIV
|
2026-10-30 | 269d | |
| K260306 | CLEARED | NEW | -- |
RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
Code: OMP
• General, Plastic Surgery
|
Smith & Nephew Medical, Ltd.
↳ SNN
|
2026-10-30 | 273d | |
| K260058 | CLEARED | NEW | -- |
Kerecis Express (50250)
Code: KGN
• Unknown
|
Kerecis Limited
PRIV
|
2026-10-30 | 295d | |
| K253095 | CLEARED | NEW | -- |
ULSPIRA TS Nitric Oxide Therapy System
Code: MRN
• Anesthesiology
|
Airgas Therapeutics, LLC
PRIV
|
2026-10-30 | 402d | |
| DEN250054 | DE NOVO | NEW | -- |
Virtuoso Endoscopy System
Code: SJS
• Unknown
|
Virtuoso Surgical, Inc.
PRIV
|
2026-10-30 | 394d | |
| P980016 | APPROVED | MOD | -- |
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
Code: LWS
• Cardiovascular
|
Medtronic Cardiac Rhythm Disease Management
↳ MDT
|
2026-10-29 | 27d | |
| P970004 | APPROVED | MOD | -- |
InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator 97800), (SNS Urinary Neurostimulator I
Code: EZW
• Gastroenterology, Urology
|
Medtronic Neuromodulation
↳ MDT
|
2026-10-29 | 29d | |
| P960009 | APPROVED | MOD | -- |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS Neurostimulator Implantable B35200)
Code: MHY
• Neurology
|
Medtronic, Inc.
MDT
|
2026-10-29 | 29d | |
| P840001 | APPROVED | MOD | -- |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify,
Code: LGW
• Neurology
|
Medtronic Neuromodulation
↳ MDT
|
2026-10-29 | 29d | |
| P190023 | APPROVED | MOD | -- |
Navitor Transcatheter Aortic Valve Implantation System
Code: NPT
• Cardiovascular
|
ABBOTT MEDICAL
↳ ABT
|
2026-10-29 | 170d | |
| P160026 | APPROVED | MOD | -- |
LIFEPAK® 35 monitor/defibrillator
Code: MKJ
• Cardiovascular
|
Physio-Control, Inc.
PRIV
|
2026-10-29 | 30d | |
| P080025 | APPROVED | MOD | -- |
InterStim Therapy System, Verify Evaluation System (SNS Bowel Neurostimulator 97800), (SNS Bowel Neurostimulators Impl
Code: QON
• Gastroenterology, Urology
|
Medtronic Neuromodulation
↳ MDT
|
2026-10-29 | 29d | |
| P010031 | APPROVED | MOD | -- |
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
Code: NIK
• Cardiovascular
|
Medtronic Cardiac Rhythm Disease Management
↳ MDT
|
2026-10-29 | 27d | |
| K263648 | CLEARED | MOD | -- |
Vitrea Advanced Visualization, Version 7.16
Code: LLZ
• Radiology
|
Canon Medical Informatics, Inc.
PRIV
|
2026-10-29 | 27d | |
| K263628 | CLEARED | MOD | -- |
ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)
Code: QZZ
• Orthopedic
|
Onkos Surgical, Inc.
PRIV
|
2026-10-29 | 29d | |
| K263602 | CLEARED | MOD | -- |
Arthrex Plates, Screws and Pins, and Washers
Code: HRS
• Orthopedic
|
Arthrex, Inc.
PRIV
|
2026-10-29 | 29d | |
| K263598 | CLEARED | MOD | -- |
VasQ
Code: QVQ
• Cardiovascular
|
Laminate Medical Technologies
PRIV
|
2026-10-29 | 29d | |
| K263596 | CLEARED | MOD | -- |
DLP Coronary Ostial Cannulae
Code: DWF
• Cardiovascular
|
Medtronic, Inc.
MDT
|
2026-10-29 | 29d | |
| K263582 | CLEARED | MOD | -- |
KeriFlex® MCP and PIP Finger Joint Prostheses
Code: KYJ
• Orthopedic
|
Keri Medical SA
PRIV
|
2026-10-29 | 29d | |
| K263530 | CLEARED | MOD | -- |
V-Pro maX 2 Low Temperature Sterilization System
Code: MLR
• General Hospital
|
STERIS
PRIV
|
2026-10-29 | 30d | |
| K263459 | CLEARED | NEW | -- |
SWICS
Code: GCJ
• Gastroenterology, Urology
|
Bloom Surgical, Inc.
PRIV
|
2026-10-29 | 31d | |
| K263065 | CLEARED | NEW | -- |
MicroPort Total Knee System
Code: JWH
• Orthopedic
|
Suzhou Microport Orthorecon Co., Ltd.
PRIV
|
2026-10-29 | 58d | |
| K262960 | CLEARED | NEW | -- |
Cerclage Cabling System
Code: JDQ
• Orthopedic
|
Pioneer Surgical Technology, Inc. dba EXALTA Group
PRIV
|
2026-10-29 | 65d | |
| K262839 | CLEARED | MOD | -- |
Cleerly ISCHEMIA
Code: QXZ
• Cardiovascular
|
Cleerly, Inc.
PRIV
|
2026-10-29 | 79d | |
| K262756 | CLEARED | NEW | -- |
Zirconia Dental Ceramics and Staining Solution
Code: EIH
• Dental
|
Fanen New Materials Technology (Suzhou) Co., Ltd.
PRIV
|
2026-10-29 | 87d |
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