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510(K) CLEARANCES 84 ▲14 RECALLS POSTED 39 ▲27 CLASS I 6 ▲2 PMA DECISIONS 47 ▲11WEEK ENDING 2026-09-20 / FDA DATA AS OF 2026-10-05

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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR

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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.

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The desk

Request a quote

Describe what you need once. No supplier sees it without your consent, and none except those matched to the categories you picked.

Private
Your request is never published, never listed and never sold. The people who run the desk here can read it, and every read they make is logged.
Free, and never pay-to-play
No supplier pays to receive your request, and nobody can buy their way to the front of your list.
No files, and nothing confidential
The request is a summary. Drawings and specifications change hands after an introduction, under your own agreements.

When a supplier is interested in your request, you hear from us.

What are you looking for?Manufacturing or engineering services for a deviceSomeone to make it, assemble it, sterilize it, package it, test it, or help design it.Buy a finished productA device or a component you are buying rather than having made. One more question after this.Components, materials, or equipmentResin, tubing, adhesives, machines, tooling, and the rest of the bill of materials.

If you are buying a finished product, which of these?An existing product, off the shelfIt already exists and you want to source it.Made to my specification, under my brandIt does not exist yet. This is a contract manufacturing request, so it goes to the services list.

The project

Which categories?

Pick up to three. Your request goes to a small number of suppliers in total, so selecting more categories does not reach more of them.

Cleanroom assembly and kittingPackaging: development, validation, testingSterilization validationSterilization processingCleaning and decontaminationDiagnostics consumables manufacturingInjection moldingExtrusionMachiningElectronics and PCBACatheter and tubingDesign and developmentRegulatory and quality consultingLab testingClinical and hospital reprocessingSoftware and firmwareTooling and automationAdditive manufacturingTextiles and nonwovensFull-service contract manufacturingOther

AnesthesiologyCardiovascularClinical ChemistryClinical ToxicologyDentalEar, Nose, ThroatGastroenterology, UrologyGeneral HospitalGeneral, Plastic SurgeryHematologyImmunologyMedical GeneticsMicrobiologyNeurologyObstetrics/GynecologyOphthalmicOrthopedicPathologyPhysical MedicineRadiology

Resins and polymersMetalsAdhesivesComponents and subassembliesPackaging materialsProduction equipmentInspection and test equipmentCleanroom suppliesSoftwareOther

Describe what you need

Include nothing confidential. Specifications and drawings change hands after an introduction, under your own agreements. This form does not accept files, on purpose: the safest way to not lose a document is to not hold it.

What stage is it at?

Prototype quantity

Expected annual volume

Timeline

Any hard requirements?

Every supplier your request goes to sees these, so only tick what is genuinely required.

US onlyISO 13485 requiredCleanroomFDA registeredSterile barrier packagingClass III or PMA experience

You

Your name

Work email

We send one message here to confirm the request. Nothing goes to any supplier before you open it.

Company

Location

A city and a country is enough.

Phone (optional)

Regulatory context (optional)

Useful to a supplier reading your request. “I don’t know” is a real answer and is welcome.

Device class

510(k) status

Is it an IVD?

Share my request with up to five matched suppliers.Nothing is sent to anybody until you tick this and confirm your email address. Your request goes to matched suppliers privately. It is never published, never listed and never sold.Keep me anonymous until I accept an introduction.Your name, company and contact details are held back, and so is anything in your description that would identify you. Suppliers see the project and answer on that. It is slower, because a supplier deciding whether to bid has less to go on, and a person here reads every anonymous request before it goes anywhere.

Role

What happens to your request

You confirm the email address. Nothing is matched and nothing reaches any supplier before you open that link.
No supplier sees your request except those matched to the categories you picked, and in the service categories the publisher serves itself, the publisher is the only match; network rules lists those categories. The people who run the desk here can also read it, and every read they make is logged.
Suppliers answer Interested or Pass. If one is interested, we ask you before any of your contact details reach them.

What this desk will never do

Charge a supplier to receive your request. Routing is never gated by payment.
Let anyone buy their way to the front of your matched list.
Publish your request, list it, or sell it.
Show you a supplier score. Those figures are internal and stay internal.
Hold your drawings. There is no upload here, on purpose.

If you would rather look first

The FDA data on this site answers a real part of the sourcing question on its own: who is registered, what they have cleared, what has been recalled, and which product codes they list against.

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The directory
What verified means
FDA data
What we hold, and for how long

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Medical Device Manufacturing is published by Life Science Outsourcing, Inc. Editorial decisions are made independently of sponsors. Sponsored content is always labeled.

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