Aug 28, 2026
K262735
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
Medtronic, Inc.
- MXD
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Aug 28, 2026
K262722
Primal K-Wire (P99-193-1410)
Paragon 28, Inc.
- HTY
- Class II
Aug 28, 2026
K262013
Kiba CTO Crossing Catheter
Reflow Medical, Inc.
- PDU
- Class II
Aug 28, 2026
K261830
FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)
Ortler Global Tibbi Gerecler Anonim Sirketi
- HRS
- Class II
Aug 28, 2026
K261582
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
- NUV
- Class II
Aug 28, 2026
K261378
Rayvolve AZchest
AZmed
- QBS
- Class II
Aug 28, 2026
K261176
Zoom 4S Catheter
Imperative Care, Inc.
- QJP
- Class II
Aug 28, 2026
K260617
Tigertriever 13 Ultra Revascularization Device
Rapid Medical Ltd.
- NRY
- Class II
Aug 28, 2026
K260517
Automatic Core Biopsy Instrument
Zhejiang Curaway Medical Technology Co., Ltd.
- KNW
- Class II
Aug 28, 2026
K260343
Carescape Canvas 1000; Carescape Canvas Smart Display
GE Healthcare Finland Oy
- MHX
- Class II
Aug 28, 2026
K260203
Fule Vertebroplasty Balloon Catheter
Beijing Fule Science & Technology Development Co., Ltd.
- HRX
- Class II
Aug 28, 2026
K260047
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
Roche Molecular Systems, Inc.
- PGX
- Class II
Aug 28, 2026
K260045
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)
Roche Molecular Systems, Inc.
- OZN
- Class II
Aug 28, 2026
K254261
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
- MQL
- Class II
Aug 28, 2026
K253954
X-Guide Surgical Navigation System
X-Nav Technologies, LLC
- QRY
- Class II
Aug 28, 2026
K253630
Mpact 3D Metal Foam
Medacta International S.A.
- LPH
- Class II
Aug 27, 2026
K262744
GenesisX RMN
Stereotaxis, Inc.
- DXX
- Class II
Aug 27, 2026
K262677
Iconix Knotless T
Riverpoint Medical
- MBI
- Class II
Aug 27, 2026
K262654
Dexus Prosthetic System (MSL2, MSR2)
Zhejiang Qiangnao Technology Co.,Ltd
- GXY
- Class II
Aug 27, 2026
K262268
Optiflow Oxygen Kit (AA484J)
Fisher and Paykel Healthcare Limited
- BTT
- Class II
Aug 27, 2026
K262104
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
Ram.Shaw Pte., Ltd.
- LRK
- Class II
Aug 27, 2026
K261821
1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
- GEX
- Class II
Aug 27, 2026
K261802
Glidewell™ Denture Base Resin
Prismatik Dentalcraft, Inc.
- EBI
- Class II
Aug 27, 2026
K261360
EasyCare Tx 2
Resmed Corp
- MOD
- Class II
Aug 27, 2026
K260870
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
Gebauer Company
- MLY
- Unclassified