Medical Device & IVD Blog
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 FDA's 2025 draft guidance targets skin-tone accuracy bias.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.
Hong Kong MDD: 20 Local Responsible Persons Hold 44% of 13,049 Device Listings
13,049-record Hong Kong MDACS analysis: US-made devices lead at ~28%, the top 20 LRPs hold 44% of listings, and 2025 saw a record 4,981 listings before mandatory procurement rules.
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.
Israel MOH Device Register: 28,800 Devices, 92% Imports, and Importer Concentration
Israel's MOH register lists 28,821 medical devices — 91.8% imported, the US/Germany/China supply 53.6%, and 2,111 importers (IRHs) hold the licence layer.
Japan PMDA Device Landscape: 88,900 Approved Products and MAH Concentration
Japan's PMDA database lists ~88,900 approved medical devices held by 2,796 MAHs; the top 50 MAHs hold 40.8%, and a 2021 cluster reflects the e-IFU/UDI mandate.
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.
Vietnam MOH Device Register: 108,600 Valid Registrations and a 3× Decree 98 Surge
Vietnam's MOH register holds 108,658 valid registrations across 21,871 applicants; new filings tripled in 2022 under Decree 98. Highly fragmented (HHI 16).
Taiwan TFDA Registry: 52,726 Devices, Import Dependence, and Applicant Concentration
Analysis of Taiwan's TFDA medical device register shows 52,726 active devices. 74.1% are imported (US 22.6%, Germany 9.5%), Class II dominates at 52.9%, and top 10 applicants hold 14.5%.
UK MHRA Device Register: 22,554 Devices, UK Manufacturing Base & Post-Brexit Registration
Analysis of the UK MHRA device register shows 22,554 registered devices. UK manufacturers hold 33.5%, IVD accounts for 37.7%, and the top 10 manufacturers hold 13.1% of registrations.
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.
Singapore HSA Registry: 20,600 Devices, Ownership, and Registrant Concentration
Analysis of Singapore's medical device register shows 20,599 approved devices across 859 registrants. Top 20 registrants hold 35.5%, while US product owners hold 37.9% of all devices.
EU AI Act for Medical Devices: August 2028 Deadline and MDR Dual Compliance Strategy
EU AI Act Omnibus extends medical device AI compliance to August 2, 2028. Dual MDR strategy, data governance, human oversight, tech doc integration, and preparation timeline.