# 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.

**Instant Full CSV Unlock $4.99 one-time · Lite Alert from $5/month**

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Get Instant Full CSV Unlock — $4.99 → [See all plans](#pricing)

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

Have a key? Paste it to unlock the full CSV (up to 500 rows):

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

## Unlock the complete deliverable

Your free search above is complete. The full CSV adds every matching row with all columns (up to 500); the free CSV has 3 (10 when you confirm your email).

Tailor unlock for: My businessClient / agency auditSales / lead list

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✓ Live public data, refreshed 2026-11-03 · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

Preview what the unlock includes
- Every matching row, up to 500 (the free CSV has 3; 10 when you confirm your email)
- Columns: Record, Specialty, Date, Review days, Recall class, plus each record's source link
- CSV that opens in Excel or Google Sheets and imports into a CRM

Already paid? Enter your key or email to unlock

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## Top FDAPulse records

- [SmartIPL_NI System (K241973)](/report/fdapulse/smartipl-ni-system-k241973-il--k241973) — 806
- [Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)](/report/fdapulse/multiple-therapy-aesthetic-treatment-device-bhs-202-unyque-fl--k243223) — 715
- [TECAR Therapy Device (TC2000, TC2001) (K252288)](/report/fdapulse/tecar-therapy-device-tc2000-tc2001-k252288-cn--k252288) — 447
- [Kentrospine Viktr-MIS® Pedicle screw system (K252139)](/report/fdapulse/kentrospine-viktr-mis-pedicle-screw-system-k252139-in--k252139) — 446
- [BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer®](/report/fdapulse/bd-vacutainer-serum-blood-collection-tubes-bd-vacutainer-nj--k252344) — 445

## Latest top-scored records

| Record | Specialty | Type | Date |
|---|---|---|---|
| Class I recall Z-0127-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 |
| Class I recall Z-0132-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 |
| Class I recall Z-0131-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 |
| Class I recall Z-0128-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 |
| Class I recall Z-0126-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 |

### Browse by record type

[510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls)

### Browse by specialty

[Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic)

### Browse by record type by specialty

[Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances)

[All FDAPulse hubs](/hub/fdapulse) · [RSS feed](/feed/fdapulse.xml)

## Get new FDAPulse records by email (free, weekly)

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[See this week's digest](/digest/fdapulse)

## Plans

Monthly
Yearly

### 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

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### 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

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### 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

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### 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

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### 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)

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## 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

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### 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

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### 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

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### Healthcare Vendor Bundle

$14.99 one-time

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

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### Compliance Consultant Bundle

$14.99 one-time

- Full CSV unlocks for EPA noncompliance and FDA recall records

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

Payments are processed securely by Stripe. Refunds are available by default within the first 14 days of paid service.

[Free weekly digest](/digest/fdapulse) · [Embed this feed on your site](/embed) · [RSS](/feed/fdapulse.xml)

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

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Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.