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FDAPulse: new 510(k) clearances and device recalls by specialty

FDAPulse tracks 764 records from U.S. FDA openFDA (510(k) clearances and device enforcement reports), last refreshed 2026-11-03, for MedTech regulatory and QA consulting firms, contract manufacturers and specialty device distributors. Search, filter and preview free; CSV unlocks, alerts and API access start at $4.99. Every record links to its official source.

Recent FDA 510(k) clearances and Class I/II/III device recalls, filtered by review panel and record type, with review times and recall reasons in plain view.

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Long-tail intelligence feed for MedTech regulatory and QA consulting firms, contract manufacturers and specialty device distributors

LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Predicate Speed & CAPA Advisory Opportunity Score is a heuristic estimate, not advice.

Top FDAPulse records

Latest top-scored records

RecordSpecialtyTypeDate
Class I recall Z-0127-2027: Ventec Life Systems, Inc.OtherClass I2026-10-28
Class I recall Z-0132-2027: Ventec Life Systems, Inc.OtherClass I2026-10-28
Class I recall Z-0131-2027: Ventec Life Systems, Inc.OtherClass I2026-10-28
Class I recall Z-0128-2027: Ventec Life Systems, Inc.OtherClass I2026-10-28
Class I recall Z-0126-2027: Ventec Life Systems, Inc.OtherClass I2026-10-28

Browse by record type

510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

Browse by specialty

Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

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Plans

Instant Full CSV Unlock

$4.99 one-time

  • One-time $4.99: full CSV of your current search (up to 500 rows instead of the free 3-row sample)
  • Unlocked instantly with your key; yours to keep

Lite Alert

$5 / month ($0.16/day)

  • Weekly email of new clearances and recalls for one specialty. Billed monthly (or yearly at the annual price); cancel any time

Solo / Micro Starter

$29 / month ($0.95/day)

  • Weekly digest of clearances and recalls across all specialties. Billed monthly (or yearly at the annual price); cancel any time
  • All filters
  • 100-row CSV each week

Regulatory Watch

$249 / month ($8.19/day)

  • Daily 510(k) clearance and device recall alerts by review panel. Billed monthly (or yearly at the annual price); cancel any time
  • Full CSV export
  • API access

QA Consulting Pro

$499 / month ($16.41/day)

  • Competitor and product-code watchlists. Billed monthly (or yearly at the annual price); cancel any time
  • Class I/II recall alerts within a day of posting
  • Webhook push and API access (5 seats)

More ways to buy

500 API / MCP Credits

$9.99 one-time

  • 500 full (unredacted) REST or MCP calls across every product
  • Credits never expire

Unlimited API / MCP Key

$29 / month

  • Unlimited full REST and MCP calls across every product. Billed monthly (or yearly at the annual price); cancel any time
  • For Make, Zapier, n8n and AI agents

Full Dataset Snapshot

$39.00 one-time

  • One-time download of every real record we hold for this product as CSV
  • Cleaned, deduplicated, with source links

Healthcare Vendor Bundle

$14.99 one-time

  • Full CSV unlocks for group practices and FDA clearances/recalls

Compliance Consultant Bundle

$14.99 one-time

  • Full CSV unlocks for EPA noncompliance and FDA recall records

API: 10 free calls per day without a key. Datasets contain public records only, at organization level.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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