Karl Storz Endoscopy-America, Inc. (contract manufacturer, Auburn, MA): 15 new FDA device listings, incl. system, irrigation, urological
Karl Storz Endoscopy-America, Inc. (Auburn, Massachusetts): 15 new FDA device listings, incl. system, irrigation, urological. Its amount of 15 is top-decile (95th percentile of 2,709 records). Dated 28 days ago, it is in the active follow-up window. Score 90/100. As of 2026-11-04, 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: 15 · 95th percentile of 2,709 DeviceEstablishmentPulse records · 7.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 72 related MA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Karl Storz Endoscopy-America, Inc. |
| Owner / operator | Karl Storz Se & Co Kg |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Repack or Relabel Medical Device |
| Location | Auburn, MA, US |
| New listings | 15 |
| Devices | System, Irrigation, Urological; Nasopharyngoscope (Flexible Or Rigid); Pump, Portable, Aspiration (Manual Or Powered); Insufflator, Hysteroscopic; Arthroscope; Endoscopic Irrigation/Suction System; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Endoscopic Grasping/Cutting Instrument, Non-Powered; Hysteroscope (And Accessories); Laparoscope, General & Plastic Surgery |
| Product codes | LJH, EOB, BTA, HIG, HRX, OCX, KNF, OCZ, HIH, GCJ, OSV, HIF |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology, Ear, Nose, Throat, General, Plastic Surgery, Obstetrics/Gynecology, Orthopedic |
| Brand names | ENDOMAT SELECT; SUPRALOOP; KARL STORZ Endoscopic Accessories for Urology; UNIDRIVE Select System; UNIDRIVE SIII System; KARL STORZ Trocars with Valve Seals; Smart Smoke Evacuation; ENDOFLATOR + |
| First new listing | 2026-06-17 |
| Latest new listing | 2026-10-08 |
| FDA registration number | 2020550 |
| Registration expires | 2027-12-31 |
| amount percentile | 95th of 2,709 (median 2, 7.5x median) |
| Peer records CSV (73 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: 2026-10-08
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MA first): Philips North America LLC (other, Cambridge, MA) · Performance Fibers OEM LLC (contract manufacturer, Mansfield · Isomedix Operations Inc. (contract sterilizer, Northborough, · Millstone Medical Outsourcing LLC. (contract manufacturer, F · Isomedix Operations Inc. (contract sterilizer, Northborough, · 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, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Karl Storz Endoscopy-America, Inc. and 73 Massachusetts peers
- Massachusetts DeviceEstablishmentPulse records like this one: 73
- Karl Storz Endoscopy-America, Inc.'s amount: 95th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $14,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
90 / 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.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Karl Storz Endoscopy-America, Inc. in Auburn, Massachusetts?
Karl Storz Endoscopy-America, Inc. (Auburn, MA), a contract manufacturer, added 15 FDA device listings between 2026-06-17 and 2026-10-08.
How does Karl Storz Endoscopy-America, Inc. compare to other Massachusetts DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 15 is 7.5x the median of 2 across 2,709 records. It is 28 days old, still within a typical 45-day follow-up window. Its Score of 90/100 puts it among the stronger signals in this feed.
Karl Storz Endoscopy-America, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | Auburn, MA | 15 | 95th | 2026-10-08 |
| Millstone Medical Outsourcing LLC. | Fall River, MA | 24 | 97th | 2026-10-08 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
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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.