A & A Medical, Inc.
Alpharetta, GA, US
A & A Medical, Inc. appears in FDA device records in Alpharetta, GA. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for A & A Medical, Inc. between 1988 and 2001. The busiest year on record is 2001, with 7. The most recent is 2001, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 5 |
| 1997 | 4 |
| 1998 | 2 |
| 2000 | 2 |
| 2001 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013491 | HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 | LKF | Substantially Equivalent | |
| K013437 | SF SH CATHETER, MODEL R65-945 | LKF | Substantially Equivalent | |
| K003949 | TACKER, MODEL R65-933 | OCW | Substantially Equivalent | |
| K011512 | MMODIFICATION TO LAMINARIA | HDY | Substantially Equivalent | |
| K010510 | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 | HET | Substantially Equivalent | |
| K010789 | CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 | GCJ | Substantially Equivalent | |
| K010056 | UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 | LKF | Substantially Equivalent | |
| K000027 | INSUFFLATION NEEDLE, MODEL R65-933 | HIF | Substantially Equivalent | |
| K994256 | SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 | GCJ | Substantially Equivalent | |
| K974038 | THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT | JCX | Substantially Equivalent | |
| K974138 | ROCKET ELECTRODE | HGI | Substantially Equivalent | |
| K974032 | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR | HFC | Substantially Equivalent | |
| K973671 | ENDOCERVICAL BLOCK NEEDLE | HEE | Substantially Equivalent | |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | MFD | Substantially Equivalent | |
| K972245 | TOM CAT F.L., TOM CAT S.L. | MFD | Substantially Equivalent | |
| K895551 | ROCKET BONE MARROW NEEDLE | GDM | Substantially Equivalent | |
| K894489 | GYNECOLOGIC EXAMINATION KIT | HIB | Substantially Equivalent | |
| K885274 | ROCKET ENDOCERVICAL BRUSH | HHT | Substantially Equivalent | |
| K883805 | ROCKET SEX CRIME KIT | FMC | Substantially Equivalent | |
| K884685 | ROCKET FETAL BLOOD SAMPLING TRAY | HGW | Substantially Equivalent | |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | HHM | Substantially Equivalent | |
| K883806 | ROCKET INTRAUTERINE SOUND | HHM | Substantially Equivalent | |
| K884042 | ROCKET CERVICAL SPATULA | HHT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- HFCAspirator, Endocervical
- MFDCannula, Intrauterine Insemination
- LKFCannula, Manipulator/Injector, Uterine
- HDYDilator, Cervical, Hygroscopic-Laminaria
- HGIElectrocautery, Gynecologic (And Accessories)
- OCWEndoscopic Tissue Approximation Device
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- GDMNeedle, Aspiration And Injection, Reusable
- FMCPatient Examination Glove
- HGWSampler, Blood, Fetal
- HEESet, Anesthesia, Paracervical
- HHMSound, Uterine
- HHTSpatula, Cervical, Cytological
- HIBSpeculum, Vaginal, Nonmetal
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 A & A Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for A & A Medical, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain