Associated Medical Products Co.: FDA filings under this applicant name

FDA lists 29 510(k) clearances under the applicant name “Associated Medical Products Co.” (first 1980, latest 1997), across 17 product codes in 7 review panels. Median 510(k) review time under this name: 45 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
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Top product codes

Product codeDeviceSubmissions510(k) clearances
LDQ55
FRGWrap, Sterilization44
FSMTray, Surgical, Instrument33
LROGeneral Surgery Tray33
DQOCatheter, Intravascular, Diagnostic11
FKOCatheter, Peritoneal Dialysis, Single Use11
FMCPatient Examination Glove11
FRLFiber, Medical, Absorbent11
HFDWasher, Endometrial11
HOZSponge, Ophthalmic11

Plus 7 more product codes.

Review panels

Most recent Associated Medical Products Co. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K932221NEUROLOGICAL OR CRANI TRAYS (PACKS)LRO1997-03-191412
K932216C-SECTION, LABOR & DELIVERY TRAYS (PACKS)MLS1994-04-19347
K930507CUSTOM ORTHOPAEDIC TRAYS (PACKS)HTS1994-02-22386
K932217MAJOR, MINOR, BASIN TRAYS (PACKS)LRO1993-11-15192
K932220LAP CHOLY TRAYS (PACKS)LRO1993-09-27143
K932218CARDIAC CATH OR ANGIOGRAPHIC TRAYSDQO1993-08-27112
K932219SUTURE SET OR LACERATION TRAYS (PACKS)KDD1993-07-0963
K842983AMPCO OPTHALMIC TRAYHOZ1985-05-22296
K843114AMPCO PROCEDURE TRAYS / PACKS—1984-08-080
K823839AMPCO KIDNEY DIALYSIS TRAYKOC1983-03-2998

19 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Associated Medical Products Co..

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 Associated Medical Products Co.?

FDA lists 29 510(k) clearances under the applicant name “Associated Medical Products Co.” (first 1980, latest 1997), across 17 product codes in 7 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 Associated Medical Products Co.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Associated Medical Products Co. is 45 days.

Which FDA product codes appear under Associated Medical Products Co.?

The most frequent FDA product codes under this applicant name are LDQ (device, 5); FRG (Wrap, Sterilization, 4); FSM (Tray, Surgical, Instrument, 3).

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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