American Edwards Laboratories: FDA filings under this applicant name

FDA lists 89 510(k) clearances under the applicant name “American Edwards Laboratories” (first 1980, latest 1987), across 38 product codes in 8 review panels. Median 510(k) review time under this name: 47 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Edwards Lifesciences, based on public ownership records.

510(k) clearances per year

Top product codes

Plus 28 more product codes.

Review panels

• Cardiovascular (51)
• Gastroenterology and Urology (16)
• General Hospital (9)
• Orthopedic (7)
• Ophthalmic (1)
• Pathology (1)
• Radiology (1)
• General and Plastic Surgery (1)

Most recent American Edwards Laboratories 510(k) clearances

79 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named American Edwards Laboratories.

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under American Edwards Laboratories (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via FRN)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
• E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)

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.

• American Dade (149 510(k)s)
• American Medical Systems, Inc. (82 510(k)s)
• American Bioproducts Co. (79 510(k)s)
• American Monitor Corp. (73 510(k)s)
• American Pharmaseal Div. Ahsc (64 510(k)s)
• American Bentley (59 510(k)s)
• American Hospital Supply Corp. (56 510(k)s)
• American Research Products Co. (56 510(k)s)
• American Orthodontics (46 510(k)s)
• American Diagnostic Corp. (39 510(k)s)
• American Laboratory Supply, Inc. (36 510(k)s)
• American Sterilizer Co. (36 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under American Edwards Laboratories?

FDA lists 89 510(k) clearances under the applicant name “American Edwards Laboratories” (first 1980, latest 1987), across 38 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by American Edwards Laboratories?

The median time from FDA receipt to decision across 510(k)s cleared under the name American Edwards Laboratories is 47 days.

Which FDA product codes appear under American Edwards Laboratories?

The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 7); DQO (Catheter, Intravascular, Diagnostic, 6); DYG (Catheter, Flow Directed, 6).

Next steps

• See all 89 American Edwards Laboratories clearances with predicates and recalls
• Run predicate analysis for product code HRX, American Edwards Laboratories's most frequent

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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