United States
287 articles
Home Oxygen Concentrator Recalls: 44 FDA CAW Records and 11 Class I Actions
Home oxygen concentrator CAW recall analysis: 44 FDA recall records; 33 have enforcement classifications, including 11 Class I. Nidek leads the Class I fire record across 52,664 MAUDE reports.
FDA Infusion Pump Recalls: 1,180 Events and the Class I Software-and-Alarm Causes
FDA infusion pump recall analysis: 1,180 events, 189 Class I actions. Software and alarm defects dominate the most serious recalls, led by BD, Baxter, and ICU Medical.
Pulse Oximeter 510(k) Map: 726 Predicate Clearances and the FDA Pigmentation Reckoning
Pulse oximeter 510(k) analysis: all 726 DQA clearances are predicate-based, led by Masimo, Nonin, and Nellcor. FDA's 2025 draft guidance targets skin-tone accuracy bias.
FDA Surgical Stapler Recalls: 19 Class I Actions and the Misfire-and-Fragmentation Record
FDA surgical stapler analysis: 222 enforcement actions, 19 Class I recalls. Ethicon dominates the most-serious actions; malformation, misfire, and fragmentation lead, across 31,000 MAUDE reports.
510(k)-Exempt in 2026: How to Check the QMSR, Registration, and UDI Duties You Owe
A 510(k) exemption removes one filing, not your compliance program. How to confirm exempt status and the QMSR, registration, and UDI duties that survive.
FDA Establishment Registration Lookup: Manufacturer, Importer, and US Agent Roles
How to read an FDA establishment registration to identify manufacturer, contract manufacturer, importer, and US agent roles — with role-count data.
GUDID Data-Quality Checklist: What Distributors Should Verify Before a Contract
A portfolio GUDID data-quality checklist for distributors — check labeler completeness, missing descriptions, and identifier integrity per contract.
How to Check if a Medical Device Was Recalled: FDA Recall Database Lookup
How to search the FDA recall database and Enforcement Reports to check if a device was recalled, what Class I/II/III means, and how to read a recall status — with data on recall volume and classes.
How to Verify a Medical Device UDI: A GUDID Lookup Workflow for Hospital Purchasing
How to look up and verify a medical device's UDI in FDA AccessGUDID before purchasing, what the DI fields mean, and the data-quality gaps that break a lookup.
PMA Supplement Types Explained: 180-Day, Panel-Track, Real-Time, 30-Day, and Special
How to choose the right PMA supplement type under 21 CFR 814.39 — 180-day, panel-track, real-time, 30-day notice, and special — with data on what changes actually drive supplements.
FDA Class I Device Recalls: 3,510 Events, Firms, and Trends Since 2006
3,510 FDA Class I device recalls since 2006, led by Medtronic, Boston Scientific and Teleflex. Catheters and ventilation devices drive a sharp post-2020 rise.
FDA MAUDE Trends 2020–2025: 14.4M Reports, Diabetes Dominance, Rising Deaths
Analysis of 14.4M FDA MAUDE adverse event reports (2020–2025) shows diabetes devices account for over half of all events. Death reports rose 63% from 2020 to 2024.
Who Clears the Most FDA 510(k) Devices? 175K Records by Country and Applicant
Analysis of 175,149 FDA 510(k) clearances shows foreign applicants exceed US ones since 2021. China leads non-US at 19.1%, top 50 applicants hold under 10%.
Global Device Manufacturing Map: 24,795 FDA-Registered Establishments
FDA establishment data shows 59.7% of 24,795 registered facilities are foreign. China leads with 4,753 establishments and contract manufacturing dominates.
UDI Database Decoded: 5.08M Records Show Orthopedic Dominance, Concentration
Analysis of 5.08 million FDA GUDID records shows orthopedic devices lead at 49.6%, Cardinal Health and Medline hold 12.4% of a 10K-record sample, and Class II devices dominate at 85.3%.
FDA Medical Device Recalls Decoded: 58K Records, Root Causes, and Trends
Analysis of 58,374 FDA device recalls shows 85.8% are Class II, device design is the leading identified root cause at 13.0%, and annual recall volume peaked at 3,313 in 2017.
PMA Class III Landscape: 56,508 Records Show Cardiovascular Dominance
56,508 PMA records show cardiovascular dominates at 50.8%, top 5 applicants hold 31.5%, and the average PMA accumulates 34.5 supplements.
FDA QMSR Remediation Mandate: Pre-2026 Findings Now Require ISO 13485
IsoTis and Longhorn warning letters set FDA precedent: pre-QMSR corrective actions must now meet ISO 13485. Internal audit exposure, risk citations, and prep steps.
Medical Device Accessory Classification: EU MDR and FDA Pathways
How accessories are classified separately from parent devices under EU MDR Article 2(2) and FDA 513(f)(6), with examples, MDCG 2021-24 Rev.1 updates, and FDA's 2025-2026 reclassification initiative.
Aesthetic Device Regulation: FDA 510(k) and EU MDR for Laser, RF, and Energy Devices
How energy-based aesthetic devices — laser, RF, HIFU, IPL, cryolipolysis, and EMS — are classified and cleared by FDA and EU MDR, including special controls, Annex XVI, and 2026 compliance updates.