Public-data snapshots from official U.S. sources

FDA device clearances

510(k) and PMA decisions from the official openFDA device APIs (last 30 days in samples below). Device and applicant names are from public FDA records.

Automate alerts: Monitor new 510(k) clearances and PMA approvals by product code, applicant, or keyword with hash-based change detection.

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Recent decisions (sample)

DeviceTypeApplicantProduct codeDecision
ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110, L111); PRO PMA Boston Scientific LWP 2026-10-03
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2 (Models S701, PMA Boston Scientific Corp LWP 2026-10-03
VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) PMA Guidant Corp. NKE 2026-10-03
Elecsys EBV VCA IgG 510(k) Roche Diagnostics LSE 2026-10-02
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 510(k) GE Medical Systems Ultrasound and Primary care Diagnostics, LLC IYN 2026-10-02
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts 510(k) OsteoCentric Technologies HWC 2026-10-02
TDM Large Bone Plate and Screw System 510(k) Tdm Co., Ltd. HRS 2026-10-02
Elecsys EBV EBNA IgG 510(k) Roche Diagnostics LSE 2026-10-02
Xpert Xpress CoV-2/Flu plus 510(k) Cepheid® QOF 2026-10-02
REMEX-T(K)100C 510(k) Remedi, Inc. IZL 2026-10-02
Lung Guidance 510(k) GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC QJU 2026-10-02
Response Ortho Smart Fixator - Hexapod System 510(k) Response Ortho Solutions, LLC KTT 2026-10-02
cCeLL405 510(k) VPIX Medical, Inc. QFX 2026-10-02
Neurora 510(k) Argus Cognitive, Inc. QPF 2026-10-02
Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) 510(k) Shenzhen Ninenovo Technology Limited DQA 2026-10-02
Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System 510(k) Spinal Simplicity, LLC PEK 2026-10-02
Medical Monitor (32MD08WC) 510(k) Lg Electronics.Inc PGY 2026-10-02
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor 510(k) Steris FEB 2026-10-02
AnyPlus II Spinal Fixation System 510(k) GS Medical Co., Ltd. NKB 2026-10-02
Ventricular Catheters, Thomale Catheter 510(k) Aesculap, Inc. JXG 2026-10-02
CVS Advanced PLUS Blood Glucose Monitoring System 510(k) I-Sens, Inc. NBW 2026-10-02
Plenity-V (MC0979 / GS110) 510(k) Gelesis SRL QFQ 2026-10-02
Hemostatic Clip 510(k) Anrei Medical (Hz) Co., Ltd. PKL 2026-10-02
CentriMag™ Circulatory Support System PMA Abbott DSQ 2026-10-02
FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, PMA Farapulse, Inc. QZI 2026-10-02
Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas PMA Motiva USA, LLC FTR 2026-10-02
VNS Therapy® System PMA LivaNova USA, Inc. LYJ 2026-10-02
Sphere-9 Catheter and Affera Ablation System PMA Medtronic, Inc. QZI 2026-10-02
EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor PMA Boston Scientific Corporation LWS 2026-10-02
MediBeacon Transdermal GFR System PMA Medibeacon, Inc. SDK 2026-10-02

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