FDA Medical Device Safety & 510(k) Intelligence
Multi-year post-market surveillance integrating FDA 510(k) premarket clearances, MAUDE adverse event telemetry, and FDA recall classifications across 8 major therapeutic categories. Snapshot generated August 29, 2026.
FDA Post-Market Surveillance Matrix
Surveillance telemetry tracking FDA 510(k) clearances, MAUDE adverse events (Deaths, Injuries, Malfunctions), and Class I/II/III recalls across medical device product codes.
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Firm: ICU Medical, Inc. • Date: 2026-06-10Infusion pump recalls and adverse-event reports are displayed next to CMS safety and readmission content because medication-delivery device failures and dosing anomalies directly influence inpatient safety workflows, adverse drug events, and unplanned return days.
Potential difficult balloon deflation or catheter lumen breach during high-pressure post-dilatation in severely calcified lesions.
Firm: Boston Scientific Corporation • Date: 2025-11-14Drug-eluting coronary stent surveillance (stent thrombosis, restenosis, delivery issues) directly correlates with 30-day AMI mortality (MORT_30_AMI), post-PCI emergency readmissions, and cardiovascular surgical outcomes.
Rare firmware condition causing unexpected reversion to safety VVI pacing during high-output magnetic resonance imaging.
Firm: Abbott Medical • Date: 2025-08-20Implantable pacemaker telemetry and lead integrity signals align with heart failure mortality (MORT_30_HF) and unplanned cardiac electrophysiology hospital visits.
Dimensional mismatch between tibial tray locking mechanism and specific polyethylene insert lots causing increased micromotion.
Firm: Stryker Orthopaedics • Date: 2025-05-18Total knee replacement implant performance metrics (aseptic loosening, liner wear) tie directly to CMS COMP_HIP_KNEE complication rates and orthopedic surgical revision readmissions.
System, Surgical, Computer Controlled Instrument
Surgical Robotics & Minimally Invasive
Instrument clutch release mechanism intermittently binding when engaged in deep pelvic access angles.
Firm: Intuitive Surgical, Inc. • Date: 2025-09-30Robotic surgical system instrument clutch and force-feedback telemetry signals directly map to inpatient surgical safety composites (PSI_90), accidental punctures, and perioperative outcomes.
Proximal delivery wire micro-fracture during extreme tortuous siphon catheterization.
Firm: Medtronic Neurovascular • Date: 2024-10-15Neurovascular flow diverter apposition and thrombosis telemetry map to stroke mortality (MORT_30_STK) and perioperative neurological complications.
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Molecular Diagnostics & Infectious Disease
Contamination to in-vitro diagnostic test pouch reagent lot may result in false positives for anaerobic markers.
Firm: BioFire Diagnostics, LLC • Date: 2026-04-22Joint infection multiplex diagnostic activity is shown with complications and mortality context because pathogen identification speed and antibiotic resistance tracking prevent septic revisions and improve surgical recovery.
Material type on packaging incorrectly indicated titanium alloy Ti6Al-4V while components contained cobalt-chromium.
Firm: XTANT MEDICAL INC • Date: 2017-04-12Spinal fixation device activity is shown with readmission and complication context because orthopedic implants influence post-surgical stability, pseudarthrosis, and return visits.
Latest openFDA 510(k) records
Client-side fetched from openFDA with localStorage caching and a manual refresh option.
Loading live openFDA data…