Oct 19, 2026
K262932
AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)
Shenzhen Accompany Technology Co., Ltd.
- OHS
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 19, 2026
K262917
Reprocessed BRK Transseptal Needle
Innovative Health, LLC
- NMK
- Class II
Oct 19, 2026
K262147
CINA-Aneurysm+
Avicenna.Ai
- QIH
- Class II
Oct 19, 2026
K261203
multiFiltratePRO System
Fresenius Medical Care Renal Therapies Group, LLC
- KDI
- Class II
Oct 19, 2026
K261189
Freedom Nail Ankle Fusion System
McGinley Orthopaedic Innovations
- HSB
- Class II
Oct 19, 2026
K261109
Access MeMed BV
Beckman Coulter, Inc.
- QPS
- Class II
Oct 19, 2026
K260510
VenusCT
Linatech, LLC
- SFV
- Class II
Oct 19, 2026
K260403
7D Surgical System (10-0001)
7D Surgical ULC
- OLO
- Class II
Oct 18, 2026
K262000
Sway System (Sports Plus)
Sway Medical, Inc.
- POM
- Class II
Oct 16, 2026
K263267
Endox Test Strips
Ibt Scientific
- JOJ
- Class II
Oct 16, 2026
K263266
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
Route 92 Medical, Inc.
- NRY
- Class II
Oct 16, 2026
K263254
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)
Xiamen Compower Medical Tech. Co., Ltd.
- BTM
- Class II
Oct 16, 2026
K263234
TMINI Miniature Robotic System
THINK Surgical, Inc.
- OLO
- Class II
Oct 16, 2026
K262941
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
Bausch + Lomb, Inc.
- LPL
- Class II
Oct 16, 2026
K262523
Amber Arte
Hass Corp.
- EIH
- Class II
Oct 16, 2026
K262478
BCS Bioceramic Sealer
BCS Device Pte., Ltd.
- KIF
- Class II
Oct 16, 2026
K262443
Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
Sofradim Production
- OWT
- Class II
Oct 16, 2026
K262284
KIM BLUE
Desarrollo e Investigación Médica Aragonesa S.L.
- OTN
- Class II
Oct 16, 2026
K261782
MODO DUO Electric Pump (B11621, B11673)
Tomy International, Inc.
- HGX
- Class II
Oct 16, 2026
K261585
Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- IYN
- Class II
Oct 16, 2026
K261574
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
Hong Qiangxing (Shenzhen) Electronics Limited
- NUH
- Class II
Oct 16, 2026
K261245
Restrata
Acera Surgical, Inc.
- QSZ
- Unclassified
Oct 16, 2026
K260801
Sensinel Cardiopulmonary Management (CPM) System
Analog Devices
- MWI
- Class II
Oct 16, 2026
K260605
Lilium one (USM330)
Lilium Otsuka Co., Ltd.
- IYO
- Class II
Oct 16, 2026
K260391
AVIEW Aorta Metrics
Coreline Soft Co., Ltd.
- JAK
- Class II