Richard Wolf Medical Instruments Corp.

How does FDA spell Richard Wolf Medical Instruments Corp.?

FDA publishes this company under 5 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.

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 Richard Wolf Medical Instruments Corp. file in?

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

Showing the 25 they file in most, of 51.

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 Richard Wolf Medical Instruments Corp. had a recall?

openFDA lists 12 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

• Z-1957-2019Class IITerminatedHIH23 May 2019

  E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

• Z-2608-2016Class IITerminatedHHI19 May 2016

  The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.

• Z-1188-2016Class IITerminatedFWE29 February 2016

  Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

• Z-0789-2016Class IITerminatedHRX25 November 2015

  Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

• Z-0790-2016Class IITerminatedHRX25 November 2015

  Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

Showing the 5 most recently initiated of 12.

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 Richard Wolf Medical Instruments Corp. cleared recently?

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

Where is Richard Wolf Medical Instruments Corp. registered?

FDA lists 1 registered establishment 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.