Sep 8, 2026
K260227
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
DRTECH Corporation
- KPR
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 8, 2026
K260062
MODI System
DreaMed Diabetes, Ltd.
- QRX
- Class II
Sep 8, 2026
K260053
Power Wheelchair (OS-R-M01I)
Beijing OrionStar Technology Co., Ltd.
- ITI
- Class II
Sep 8, 2026
K254294
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
Zhejiang Geyi Medical Instrument Co., Ltd.
- HIH
- Class II
Sep 8, 2026
K253988
LiteSet Trays
Nobel Biocare AB
- KCT
- Class II
Sep 6, 2026
K261131
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)
Shenzhen Osto Medical Technology Co.,Ltd
- NUH
- Class II
Sep 6, 2026
K260396
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Fidelity BioPharma Co.
- OBP
- Class II
Sep 5, 2026
K261684
FreezeSpray TA
Cryosurgery, Inc.
- MLY
- Unclassified
Sep 5, 2026
K254135
LipoSurg ARTIST
NOUVAG AG
- QPB
- Class II
Sep 4, 2026
K262828
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
- NKB
- Class II
Sep 4, 2026
K262292
Gastric Alimetry
Alimetry , Ltd.
- MYE
- Class II
Sep 4, 2026
K262277
70 NeuGlide Catheter
Piraeus Medical, Inc.
- QJP
- Class II
Sep 4, 2026
K262235
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)
Medtronic Xomed, Inc.
- PGW
- Class II
Sep 4, 2026
K262130
ATTUNE Revision Knee System
Depuy Orthopaedics, Inc.
- JWH
- Class II
Sep 4, 2026
K262060
3D-RD-S
Radiopharmaceutical Imaging & Dosimetry, LLC
- LLZ
- Class II
Sep 4, 2026
K261935
Surgical and Prosthetic Trays
Dentsply Sirona, Inc.
- KCT
- Class II
Sep 4, 2026
K261057
ActivaScrew™ Cannulated COM
Bioretec, Ltd.
- HWC
- Class II
Sep 4, 2026
K260756
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Sentinel Medical Technologies,
- EZL
- Class II
Sep 4, 2026
K260525
NextMR Spine
MRI2CT, Inc.
- QIH
- Class II
Sep 4, 2026
K260331
IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
Siemens Healthcare Diagnostics Products, Ltd.
- DHB
- Class II
Sep 4, 2026
K260035
Digital Indeflator INFLANTE
UAB Telemedicina
- MAV
- Class II
Sep 4, 2026
K254264
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- QVF
- Class II
Sep 4, 2026
K254262
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
- PSZ
- Class II
Sep 4, 2026
K253909
NeoPEX™ Pre-Mixed Obturation Paste
NuSmile, Ltd.
- KIF
- Class II
Sep 4, 2026
K253836
FCT iStream Phase 2
Fujifilm Corporation
- JAK
- Class II