FdaApprovalPulse: PMA original approval (new class III device)
24 fdaApprovalPulse: PMA original approval (new class III device) are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-07 to 2026-10-16; the most frequent is Merz North America, Inc. with 2. Data last updated 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
24 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-07 to 2026-10-16. Most frequent: Merz North America, Inc. (2). Each record links to a full report and the official source.
Last updated 2026-11-03. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
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- Merz North America, Inc. (2)
- Vivasure Medical , Ltd. (1)
- Edwards Lifesciences, LLC (1)
- Rejoni, Inc. (1)
- Bard Peripheral Vascular, Inc. (1)
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What are the top fdaApprovalPulse: PMA original approval (new class III device) right now?
| Record | Product | Approval | Decided |
|---|---|---|---|
| Vivasure Medical , Ltd. | PerQseal® Elite Vascular Closure Device | PMA original approval (new class III device) | 2026-10-16 |
| Edwards Lifesciences, LLC | Autus Size-Adjustable Valve | PMA original approval (new class III device) | 2026-10-01 |
| Rejoni, Inc. | Juveena Hydrogel System | PMA original approval (new class III device) | 2026-09-28 |
| Bard Peripheral Vascular, Inc. | Liverty TIPS Stent Graft | PMA original approval (new class III device) | 2026-09-25 |
| MedAlliance, LLC | SELUTION SLR 014 PTCA Drug-Eluting Balloon | PMA original approval (new class III device) | 2026-09-18 |
| Promega Corporation | OncoMate® MSI Dx Analysis System | PMA original approval (new class III device) | 2026-09-15 |
| Implantica CE Reflux , Ltd. | RefluxStop® Device and RefluxStop® Deployment Tool | PMA original approval (new class III device) | 2026-08-20 |
| Spineart USA, Inc. | BAGUERA®C Cervical Disc Prosthesis | PMA original approval (new class III device) | 2026-08-10 |
| Tianjin MasterVision Technology Co., Ltd. | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | PMA original approval (new class III device) | 2026-08-05 |
| Personal Genome Diagnostics, Inc. | PGDx elio tissue complete CDx | PMA original approval (new class III device) | 2026-07-30 |
| Freenome, LLC | SimpleScreen CRC | PMA original approval (new class III device) | 2026-07-24 |
| Traferox Technologies, Inc. | TorEx Lung Perfusion System | PMA original approval (new class III device) | 2026-07-15 |
| Merz North America, Inc. | Belotero® Intense (+) Lidocaine | PMA original approval (new class III device) | 2026-07-09 |
| Artivion, Inc. | AMDS Hybrid Prosthesis | PMA original approval (new class III device) | 2026-06-26 |
| Lung Bioengineering, Inc. | LungFX device | PMA original approval (new class III device) | 2026-06-22 |
| Hepquant, LLC | 🔒 Unlock all 24 records → | ||
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 🔒 Unlock all 24 records → | ||
| Croma-Pharma GmbH | 🔒 Unlock all 24 records → | ||
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Frequently asked questions
How many fdaApprovalPulse: PMA original approval (new class III device) are listed?
24 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-16.
Can I get alerts for PMA original approval (new class III device)?
Yes. FdaApprovalPulse can email you new records matching this filter; plans are listed on the FdaApprovalPulse page.
Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). Informational only. RSS feed of new records