Medical Device Clearances & Approvals
Authoritative tracking of FDA 510(k), PMA, De Novo decisions, and digital health technology.
Last Synced: 2026-11-14 19:52 UTC
Indexed Devices
3787
✦ AI/ML Enabled
127
New Devices
2827
Modifications
960
| Submission ID | Determination | Lifecycle | AI/ML | Device Name & Code | Applicant & Market Status | Decision Date | Review Speed | Action |
|---|---|---|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| K262731 | CLEARED | NEW | -- |
Virata Spinal Fixation System
Code: NKB
• Orthopedic
|
SeaSpine Orthopedics Corporation
PRIV
|
2026-10-29 | 90d | |
| K262574 | CLEARED | NEW | -- |
Convoy Expandable Corpectomy System
Code: MQP
• Orthopedic
|
SeaSpine Orthopedics Corporation
PRIV
|
2026-10-29 | 94d | |
| K262572 | CLEARED | NEW | -- |
Symmetrix PX Spinal System
Code: MAX
• Orthopedic
|
Medtronic Sofamor Danek USA, Inc.
↳ MDT
|
2026-10-29 | 94d | |
| K262570 | CLEARED | NEW | -- |
TZ Medical Birthing Balloon Kit
Code: PFJ
• Obstetrics/Gynecology
|
TZ Medical
PRIV
|
2026-10-29 | 97d | |
| K262437 | CLEARED | NEW | -- |
Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
Code: FGB
• Gastroenterology, Urology
|
Zhejiang Geyi Medical Instrument Co., Ltd.
PRIV
|
2026-10-29 | 105d | |
| K262415 | CLEARED | NEW | -- |
OSSIX Plus
Code: NPL
• Dental
|
Datum Dental, Ltd.
PRIV
|
2026-10-29 | 106d | |
| K262318 | CLEARED | NEW | -- |
Minder® System
Code: SEM
• Neurology
|
Epi-Minder Pty, Ltd.
PRIV
|
2026-10-29 | 113d | |
| K262125 | CLEARED | NEW | -- |
Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
Code: HGX
• Obstetrics/Gynecology
|
Nenesupply Co., Ltd.
PRIV
|
2026-10-29 | 127d | |
| K260975 | CLEARED | NEW | -- |
Libertas Acetabular Liners (Acetabular Liner)
Code: JDI
• Orthopedic
|
Maxx Orthopedics, Inc.
PRIV
|
2026-10-29 | 219d | |
| K260427 | CLEARED | NEW | -- |
Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)
Code: SCS
• General Hospital
|
Lumicare Medtech Co., Ltd.
PRIV
|
2026-10-29 | 261d | |
| K260356 | CLEARED | NEW | -- |
EndoColibri
Code: NYL
• Dental
|
Koehrer Medical Engineering GmbH
PRIV
|
2026-10-29 | 268d | |
| K260337 | CLEARED | NEW | -- |
SEEG-Tx® System (STX-SYS-001)
Code: GXD
• Neurology
|
Dixi Medical
PRIV
|
2026-10-29 | 269d | |
| K253508 | CLEARED | NEW | -- |
Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
Code: LZA
• General Hospital
|
Vietglove Corporation
PRIV
|
2026-10-29 | 360d | |
| K263583 | CLEARED | MOD | -- |
Tornier Humeral Reconstruction System (HRS) Tuberosity Body
Code: KWS
• Orthopedic
|
Tornier, Inc.
PRIV
|
2026-10-28 | 28d |
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