Isomedix Operations Inc. (contract sterilizer, Whippany, NJ): 26 new FDA device listings, incl. orthopedic stereotaxic instrument
Isomedix Operations Inc. (Whippany, New Jersey): 26 new FDA device listings, incl. orthopedic stereotaxic instrument. Its amount of 26 is top-decile (98th percentile of 2,570 records). Dated 37 days ago, it serves as a historical benchmark. Score 90/100. 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: 26 · 98th percentile of 2,570 DeviceEstablishmentPulse records · 26.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 48 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Isomedix Operations Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Device in the United States for Export Only |
| Location | Whippany, NJ, US |
| New listings | 26 |
| Devices | Orthopedic Stereotaxic Instrument; Wax, Bone; Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside; Methyl Methacrylate For Cranioplasty; Filler, Bone Void, Calcium Compound; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Dura Substitute; Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Product codes | OLO, MTJ, QRR, GXP, MQV, OIS, GXQ, QSY |
| Device classes | Class II, Unclassified |
| Medical specialties | Neurology, Orthopedic |
| Brand names | Zimmer (WH) - ROSA Partial Knee System; Zimmer (WH) - CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150; Abyrx4508 (WH) - Permatage XT Settable Bone Putty; Lifenet2559 (CH1,WH*) - ReadiGraft T; Lifenet2559 (CH1,WH*) - PliaFX Pak V; Lifenet2559 (CH1,WH*) - PliaFX Pak T; Lifenet2559 (CH1,WH*) - ReadiGraft V; Abyrx4508 (WH) - Permatage Flowable Settable Bone Paste |
| First new listing | 2026-06-23 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 2245304 |
| Registration expires | 2027-12-31 |
| amount percentile | 98th of 2,570 (median 1, 26.0x median) |
| Peer records CSV (49 NJ 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: 2026-09-28
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (NJ first): MINDRAY DS USA, Inc. (contract manufacturer, Mahwah, NJ) · Medin Technologies, Inc. (contract manufacturer, Totowa, NJ) · Dsv Contract Logistics LLC (repackager or relabeler, Port Re · Isomedix Operations Inc. (contract sterilizer, S Plainfield, · DRG International, Inc. (repackager or relabeler, Springfiel · 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: Isomedix Operations Inc. and 49 New Jersey peers
- New Jersey DeviceEstablishmentPulse records like this one: 49
- Isomedix Operations Inc.'s amount: 98th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $9,800 (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 Isomedix Operations Inc. in Whippany, New Jersey?
Isomedix Operations Inc. (Whippany, NJ), a contract sterilizer, added 26 FDA device listings between 2026-06-23 and 2026-09-28.
How does Isomedix Operations Inc. compare to other New Jersey DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 26 is 26.0x the median of 1 across 2,570 records. It is 37 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.
Isomedix Operations Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Isomedix Operations Inc. | Whippany, NJ | 26 | 98th | 2026-09-28 |
| Isomedix Operations, Inc. | Minneapolis, MN | 12 | 95th | 2026-10-14 |
| C.R. Bard, Inc. | Madison, GA | 10 | 93rd | 2026-10-14 |
| Sterigenics US LLC | Los Angeles, CA | 8 | 91st | 2026-09-30 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in New Jersey
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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.