510(k) Report

FDA applicant

Thermo Forma, Inc.

Marietta, OH1 decision2002–20020 recalls

FDA records 1 decision for Thermo Forma, Inc. (Marietta, OH) in 2002: 1 510(k) clearance. All are in product code MQG (Accessory, Assisted Reproduction). No recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Thermo Forma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermo Forma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Thermo Forma, Inc.’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?

  • MQGAccessory, Assisted Reproduction1decision

What has FDA decided for it lately?

  • K021042Thermo Forma, Cryomed, Controlled Rate Freezers; Models # 7456, 7457, 7458,7459,7475,7476Thermo Forma, Inc. · 2002

The one decision as Thermo Forma, Inc. →

Other applicant names beginning “Thermo”

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

Thermo Fisher Scientific 65Thermo Electron OY 14Thermo Biostar, Inc. 5Thermo Dma, Inc. 4Thermo Temp, Inc. 4Thermo Fisher Scientific (Oxoid Ltd.) 3Thermo Orion 3Thermo Bioanalysis Corp. 2Thermo Fisher Scientific (Nalge Nunc Intl) 1Thermo-Mold Medical Products, Inc. 1Thermo Fisher Scientific (Life Technologies Holdin 1Thermo Body Wrap Systems, Inc. 1