510(k) Report

FDA applicant

New Medical Technologies GmbH

Plymouth Meeting, PA1 decision2009–20092 recalls

FDA records 1 decision for New Medical Technologies GmbH (Plymouth Meeting, PA) in 2009: 1 510(k) clearance. All are in product code GEH (Unit, Cryosurgical, Accessories). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided New Medical Technologies GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2009high 2 (2024) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — New Medical Technologies GmbH by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like New Medical Technologies GmbH’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?

  • GEHUnit, Cryosurgical, Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091721Cryosuccess, Model C-Suc-01, C-Suc-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23New Medical Technologies GmbH · 20091cites it

What has FDA decided for it lately?

  • K091721Cryosuccess, Model C-Suc-01, C-Suc-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23New Medical Technologies GmbH · 20092 recalls

The one decision as New Medical Technologies GmbH →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K091721Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item…Dec 19, 2024Class II
  • K091721Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item…Dec 19, 2024Class II