510(k) Report

FDA applicant

Robert Hirschfield

Unnamed device, MD1 decision1984–19840 recalls

FDA records 1 decision for Robert Hirschfield (Unnamed device, MD) in 1984: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Robert Hirschfield’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Robert Hirschfield since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Robert Hirschfield by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Robert Hirschfield’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

What has FDA decided for it lately?

  • K822306Bio-Band BandagesRobert Hirschfield · 1984

The one decision as Robert Hirschfield →

Other applicant names beginning “Robert”

FDA records each applicant name separately; these may or may not be the same firm.

Robert Bosch Corp. 21Robert I. Chien & Assoc., Inc. 6Robert R. Moore 5Robert W. Bauer & Assoc., Inc. 3Robert A James 2Robert R. Stevens 2Robert Reid, Inc. 2Robert B. Scott Ocularists of Florida, Inc. 2Robert J. Sislian, Inc. 1Robert C. Cameron 1Robert Shaw Controls Co. 1Robert C. Leif, Ph.D. 1