510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Acumed Instruments Corp.

Santa Barbara, CA, US

ACUMED INSTRUMENTS CORP. appears in FDA device records in Santa Barbara, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Acumed Instruments Corp. between 1979 and 1986. The busiest year on record is 1979, with 4. The most recent is 1986, with 1.

Clearances by year, as a table
510(k) clearance decisions for Acumed Instruments Corp., by decision year
YearClearances
19794
19853
19861
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K863627MICRO SURGICAL DRILL SYSTEMSubstantially Equivalent
K853660MICRO SURGICAL DRILL SYSTEMSubstantially Equivalent
K853659POWERED IRRIGATION FOR MICRO SURGICAL DRILLSubstantially Equivalent
K853658BURS FOR MICRO SURGICAL DRILL SYSTEMGFFSubstantially Equivalent
K791891ACU-MED RED MISER HEMOTHORAX BLOOD COLL.CACSubstantially Equivalent
K791399ACU-ALERTSubstantially Equivalent
K791400GASTRIC LAVAGE KIT-DISPOSABLEGBQSubstantially Equivalent
K790901I.V. TUBING ORGANIZERFPASubstantially Equivalent

Registered establishments

FDA registered establishments for Acumed Instruments Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20831242083124ACUMED INSTRUMENTS CORP.1050 Vista de la Mesa Drive, Santa Barbara, CA 93110 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Acumed Instruments Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain