Performance Fibers OEM LLC (contract manufacturer, Mansfield, MA): 58 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene
Performance Fibers OEM LLC (Mansfield, Massachusetts): 58 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene. Its amount of 58 is top-decile (99th percentile of 2,570 records). Dated 79 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 58 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 58.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 69 related MA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Performance Fibers OEM LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Mansfield, MA, US |
| New listings | 58 |
| Devices | Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Surgical, Absorbable, Polydioxanone; Suture, Absorbable, Synthetic; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polypropylene; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Absorbable, Natural; Suture, Nonabsorbable, Silk; Fastener, Fixation, Nondegradable, Soft Tissue |
| Product codes | GAT, GAM, NEW, GAN, GAR, GAW, GAQ, GAL, GAP, MBI, GAS, DXZ, GAO |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic, Cardiovascular |
| Brand names | Force Fiber; Deknatel; ORTHODEK; POLYSORB SYNTHETIC ABSORBABLE SUTURE; ForceBraid; MULTIPLE POLYAMIDE SYNTH; BONDEK; Deknatel®, Deklene®, Deklene® Maxx, Capio |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-08-17 |
| FDA registration number | 1221601 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 58.0x median) |
| Peer records CSV (70 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-17
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MA first): Philips North America LLC (other, Cambridge, MA) · Millstone Medical Outsourcing LLC. (contract manufacturer, F · Isomedix Operations Inc. (contract sterilizer, Northborough, · Draeger Medical Systems, Inc. (manufacturer, Andover, MA) · Spectrawave, Inc. (manufacturer, Bedford, MA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Performance Fibers OEM LLC and 70 Massachusetts peers
- Massachusetts DeviceEstablishmentPulse records like this one: 70
- Performance Fibers OEM LLC's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $14,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Performance Fibers OEM LLC in Mansfield, Massachusetts?
Performance Fibers OEM LLC (Mansfield, MA), a contract manufacturer, added 58 FDA device listings on 2026-08-17.
How does Performance Fibers OEM LLC compare to other Massachusetts DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 58 is 58.0x the median of 1 across 2,570 records. It is 79 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Performance Fibers OEM LLC vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Performance Fibers OEM LLC | Mansfield, MA | 58 | 99th | 2026-08-17 | This record |
| Millstone Medical Outsourcing LLC. | Fall River, MA | 24 | 98th | 2026-10-08 | Compare Performance Fibers OEM LLC vs Millstone Medical Outsourcing LLC. → |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 | View record → |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.