General Medical Co.
Jacksonville, FL, US
GENERAL MEDICAL CO. appears in FDA device records in Jacksonville, FL. 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) clearance history
FDA records hold 15 510(k) clearances for General Medical Co. between 1977 and 1993. The busiest year on record is 1977, with 4. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 4 |
| 1980 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1990 | 2 |
| 1991 | 2 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K926269 | PROCEDURE KIT | LRO | Unknown | |
| K912975 | OPERAND LUBRICATING JELLY | KMJ | Substantially Equivalent | |
| K912132 | OPERAND LUBRICATING JELLY | FHX | Substantially Equivalent | |
| K903669 | GENESIS INSUFFLATING CATHETER | BSY | Substantially Equivalent | |
| K900110 | OPERAND* LUBRICATING JELLY | KMJ | Substantially Equivalent | |
| K853635 | SUBDERM TM | EGJ | Substantially Equivalent | |
| K844652 | C.A.S.E. CONTAINER | FSM | Substantially Equivalent | |
| K831320 | DRIONIC | EGJ | Substantially Equivalent | |
| K820689 | C.S.R. WRAPPERS | FRG | Substantially Equivalent | |
| K820521 | STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K802231 | AIR VIVA II | BTM | Substantially Equivalent | |
| K772089 | LAPAROTOMY SPOGNE | EFQ | Substantially Equivalent | |
| K770583 | MEDI-PAK LEMON GLYCEOIN SWABS | KXF | Substantially Equivalent | |
| K770488 | ISOLATION GOWN | FYC | Substantially Equivalent | |
| K770476 | EXAM GOWN | FME | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013399500 | 3013399500 | GENERAL MEDICAL CO. | 5011 Gate Parkway, Bldg. 100, Jacksonville, FL 32256 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- BSYCatheters, Suction, Tracheobronchial
- EGJDevice, Iontophoresis, Other Uses
- EFQGauze/Sponge, Internal
- LROGeneral Surgery Tray
- FMEGown, Examination
- FYCGown, Isolation, Surgical
- FHXJelly, Lubricating, For Transurethral Surgical Instrument
- KMJLubricant, Patient
- FSMTray, Surgical, Instrument
- BTMVentilator, Emergency, Manual (Resuscitator)
- FRGWrap, Sterilization
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.
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 General Medical Co. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain