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

Wells Johnson Co.

Tucson, AZ, US

WELLS JOHNSON CO. appears in FDA device records in Tucson, AZ. FDA records list 15 510(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
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Wells Johnson Co. between 1983 and 1999. The busiest year on record is 1983, with 5. The most recent is 1999, with 2.

Clearances by year, as a table
510(k) clearance decisions for Wells Johnson Co., by decision year
YearClearances
19835
19841
19851
19941
19954
19971
19992
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00FRNSubstantially Equivalent
K984448BIRCOLL BALLOON DISSECTORFZWSubstantially Equivalent
K971580UAS ULTRASONIC ASPIRATOR SYSTEMLFLSubstantially Equivalent
K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTEQHSubstantially Equivalent
K945500WELLS JOHNSON FIXATION SYSTEMJEYSubstantially Equivalent
K951519WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTFWLSubstantially Equivalent
K945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHTHJMSubstantially Equivalent
K945805WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBEGEISubstantially Equivalent
K854068EXTERNAL MECHANICAL FASTENERSubstantially Equivalent
K843188WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIPJOLSubstantially Equivalent
K832521PLASTIC SUCTION TIPSGEASubstantially Equivalent
K832520SUCTION TIPSGEASubstantially Equivalent
K832519ASPIRATING TUBINGGAZSubstantially Equivalent
K832274ASPIRATORBTASubstantially Equivalent
K832273SURGICAL STOCKINGSDWLSubstantially Equivalent

Registered establishments

FDA registered establishments for Wells Johnson Co., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20240222024022WELLS JOHNSON CO.8000 S Kolb Rd, Tucson, AZ 85756 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 Wells Johnson Co. 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