Avery Biomedical Devices, Inc.: FDA filings under this applicant name

FDA lists 0 510(k) clearances under the applicant name “Avery Biomedical Devices, Inc.”, plus 2 PMA decisions, across 2 product codes in 2 review panels. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Top product codes

Product codeDeviceSubmissions510(k) clearances
GZEImplanted Diaphragmatic/Phrenic Nerve Stimulator10
LHYElectrode, Stabilized Epidural Spinal10

Review panels

PMA and De Novo decisions

NumberPathwayDeviceDecision date
P860026PMADIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR1987-01-05
P810033PMASPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-3551982-02-02

Recalls

openFDA lists no recalls under a recalling firm named Avery Biomedical Devices, Inc..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

Frequently asked questions

How many FDA 510(k) clearances are listed under Avery Biomedical Devices, Inc.?

FDA lists 0 510(k) clearances under the applicant name “Avery Biomedical Devices, Inc.”, plus 2 PMA decisions, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

Which FDA product codes appear under Avery Biomedical Devices, Inc.?

The most frequent FDA product codes under this applicant name are GZE (Implanted Diaphragmatic/Phrenic Nerve Stimulator, 1); LHY (Electrode, Stabilized Epidural Spinal, 1).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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