Boston Scientific Corporation

How does FDA spell Boston Scientific Corporation?

FDA publishes this company under 15 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Showing 8 of 15.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Boston Scientific Corporation file in?

132 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 132.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Boston Scientific Corporation had a recall?

openFDA lists 1,246 recall records naming this company across its whole history, of which 76 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

• Z-2725-2026Class IIOpen, ClassifiedKYZ30 June 2026

  Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.

• Z-2838-2026Open, ClassifiedFCL30 June 2026

  Potential for breach in sterile barrier of device packaging.

• Z-2839-2026Open, ClassifiedFCL30 June 2026

  Potential for breach in sterile barrier of device packaging.

• Z-2840-2026Open, ClassifiedFCL30 June 2026

  Potential for breach in sterile barrier of device packaging.

• Z-2771-2026Class IIOpen, ClassifiedLLZ19 June 2026

  Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.

Showing the 5 most recently initiated of 1,246.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Boston Scientific Corporation cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is Boston Scientific Corporation registered?

FDA lists 16 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.