510(k) Report

FDA applicant

Implantech Associates, Inc.

Washington, DC41 decisions1989–20201 recall

FDA records 41 decisions for Implantech Associates, Inc. (Washington, DC) from 1989 to 2020: 41 510(k) clearances. Most are in product codes FWP (Prosthesis, Chin, Internal) and LZK (Implant, Malar). Its devices cite 11 predicates, 8 of them its own earlier devices. 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2020

2007: 12014: 12018: 12019: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Implantech”

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