Sep 24, 2026
K262618
Arthrex Spine Compression FT Screw
Arthrex, Inc.
- MRW
- Unclassified
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 24, 2026
K262252
MPa Max adhesive
Den-Mat Holdings, LLC
- KLE
- Class II
Sep 24, 2026
K262183
Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
Shenzhen Nuon Medical Equipment Co., Ltd.
- OAP
- Class II
Sep 24, 2026
K262168
QIAstat-Dx BCID GN Plus AMR Panel
QIAGEN GmbH
- PEN
- Class II
Sep 24, 2026
K262149
corra® cervical plating system
Carlsmed, Inc.
- KWQ
- Class II
Sep 24, 2026
K261345
Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
- HSB
- Class II
Sep 24, 2026
K261078
Electric Scooter (FNS01,FNS03)
Anhui Jbh Medical Apparatus Co., Ltd.
- INI
- Class II
Sep 24, 2026
K260949
Disposable Belts for Polysomnography (CNSAC)
CNSAC Medshop GmbH
- MNR
- Class II
Sep 24, 2026
K260313
MD-6000S Bladder Scanner
MEDA Co., Ltd.
- IYO
- Class II
Sep 24, 2026
K260214
STA® - Liquid Anti-Xa
Diagnostica Stago, Inc.
- KFF
- Class II
Sep 24, 2026
K260114
Align® Cover and Pad Guidance Tool
CIVCO Medical Instruments Co., Inc.
- ITX
- Class II
Sep 24, 2026
K254303
KARL STORZ SUPRALOOP
Karl Storz SE & CO. KG
- KNF
- Class II
Sep 24, 2026
K254199
PicoreMax (PicoreMax)
BLUECORE COMPANY Co., Ltd.
- GEX
- Class II
Sep 23, 2026
K263049
SABER-C System
Elevation Spine
- OVE
- Class II
Sep 23, 2026
K262582
Electric wheelchair (GP100)
Suzhou Green Pine Medical Co., Ltd.
- ITI
- Class II
Sep 23, 2026
K262353
BTL-299-F
BTL Industries, Inc.
- KPI
- Class II
Sep 23, 2026
K262254
Hair Growth Comb (X-GC01)
Guangdong Ashmore Health Technology Co., Ltd.
- OAP
- Class II
Sep 23, 2026
K262207
Cemented Plus Abutment
Unidental Co., Ltd.
- NHA
- Class II
Sep 23, 2026
K262156
Anti-HCV Next
Abbott Laboratories
- MZO
- Class II
Sep 23, 2026
K262144
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece
SETAGAYA SEIKI Co., Ltd.
- EFB
- Class I
Sep 23, 2026
K262067
iFuse Granite Onyx™ Implant System
SI-BONE, Inc.
- NKB
- Class II
Sep 23, 2026
K261892
ProRib Fixation System
Costa Surgical, Inc.
- HRS
- Class II
Sep 23, 2026
K261874
Syneris PACS v.1.0.1.0
Syneris
- LLZ
- Class II
Sep 23, 2026
K261637
Single-use Flexible Bronchoscope
Hunan Vathin Medical Instrument Co., Ltd.
- EOQ
- Class II
Sep 23, 2026
K261453
G7® Acetabular System
Zimmer Biomet
- LPH
- Class II