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| Date of Final Decision | Submission Number | Device | Company | Panel (lead) | Primary product code |
|---|---|---|---|---|---|
| 2026-02-19 | K253687 | Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434) | Beckman Coulter, Inc. | MI | SEI |
| 2026-02-19 | K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | ||
| 2026-02-13 | K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | CV | DXH |
| 2026-02-13 | K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | GU | OWN |
| 2026-02-10 | K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | EN | ETN |
| 2026-02-10 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | GU | KDI |
| 2026-02-09 | K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | NE | GXY |
| 2026-01-29 | K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | DE | NHA |
| 2026-01-28 | K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | SU | OHS |
| 2026-01-27 | K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | SU | GEI |
| 2026-01-23 | K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | PM | OAP |
| 2026-01-17 | K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | NE | JXI |
| 2026-01-16 | K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | AN | BTT |
| 2026-01-15 | K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | MI | PSZ |
| 2026-01-15 | K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | OR | ODP |
| 2026-01-15 | K251357 | Esperance pHLO Aspiration System | Phenox, Ltd. | CV | NRY |
| 2026-01-14 | K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | RA | IYE |
| 2026-01-13 | K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | GU | GCJ |
| 2026-01-12 | K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | PM | IOR |
| 2026-01-09 | K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | SU | OXC |