Sep 2, 2026
K254198
Trexo Theo
Trexo Robotics, Inc.
- PHL
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 2, 2026
K254090
I-View®
Hologic, Inc.
- MUE
- Class II
Sep 2, 2026
K254026
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)
Flexicare Medical Limited.
- EOQ
- Class II
Sep 2, 2026
K253948
Momentum Acetabular Cup System
United Orthopedic Corporation
- LZO
- Class II
Sep 2, 2026
K253065
Aevumed SUPERCYNCH™ Button System
Aevumed, Inc.
- MBI
- Class II
Sep 1, 2026
K262783
RadiForce MX247W
Eizo Corporation
- PGY
- Class II
Sep 1, 2026
K262774
Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
Guangdong Horigen Mother & Baby Products Co., Ltd.
- HGX
- Class II
Sep 1, 2026
K262451
Arthrex DynaNite Staples
Arthrex, Inc.
- JDR
- Class II
Sep 1, 2026
K262269
CO2 Laser System (MBT- CO2 Laser)
Beijing Mega Beauty Technology Co., Ltd.
- GEX
- Class II
Sep 1, 2026
K261811
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
PRIMED Medical Products, Inc.
- QSO
- Class II
Sep 1, 2026
K260884
UNIDRIVE Select System
Karl Storz SE & CO. KG
- GCJ
- Class II
Sep 1, 2026
K260758
MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd.
- LNH
- Class II
Sep 1, 2026
K260656
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
GE Healthcare Finland Oy
- MHX
- Class II
Sep 1, 2026
K260613
AMI™ Plasma Cartridge, AMI™
Sequitur Health Corp.
- JID
- Class I
Sep 1, 2026
K253961
SK Knee System
Just Medical Devices (Tianjin) Co., Ltd.
- JWH
- Class II
Aug 31, 2026
K262788
Nova HD+
Aura Wellness, LLC
- SGT
- Class II
Aug 31, 2026
K262747
ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, Inc.
- OCC
- Class II
Aug 31, 2026
K262658
Automatic Digital Blood Pressure monitor (LD-526)
Honsun (Nantong) Co., Ltd.
- DXN
- Class II
Aug 31, 2026
K261718
EZFluence (RADEZ V2)
Radformation, Inc.
- IYE
- Class II
Aug 31, 2026
K261695
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
Guilin Kevin Peter Technology Co., Ltd.
- EBF
- Class II
Aug 31, 2026
K261403
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
Global Life Sciences Solutions USA, LLC
- FPB
- Class II
Aug 31, 2026
K260767
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
Kam Yuen Plastic Products , Ltd.
- OHS
- Class II
Aug 31, 2026
K260488
MULTIX Impact; MULTIX Impact C
Siemens Medical Solutions USA, Inc.
- KPR
- Class II
Aug 31, 2026
K260387
SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
Hironic Co., Ltd.
- NFO
- Class II
Aug 31, 2026
K254217
Aerloom
Evolym, LLC
- JOW
- Class II