Annex Medical, Inc.
Minnetonka, MN, US
ANNEX MEDICAL, INC. appears in FDA device records in Minnetonka, MN. FDA records list 23 510(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 23 510(k) clearances for Annex Medical, Inc. between 1989 and 1995. The busiest year on record is 1992, with 8. The most recent is 1995, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 8 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | FFL | Substantially Equivalent | |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | FCL | Substantially Equivalent | |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | FFL | Substantially Equivalent | |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | FFL | Substantially Equivalent | |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | FFL | Substantially Equivalent | |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | FFL | Substantially Equivalent | |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | FGO | Substantially Equivalent | |
| K925267 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | GCJ | Substantially Equivalent | |
| K925559 | BILIARY STONE DISLODGER | LQR | Substantially Equivalent | |
| K921401 | BIOPSY FORCEPS | DWZ | Substantially Equivalent | |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | Substantially Equivalent | |
| K922851 | CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K922678 | LOOP RETRIEVER | FFL | Substantially Equivalent | |
| K914112 | METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE | FGO | Substantially Equivalent | |
| K914111 | METAL URETERAL BASKET STONE DISLODGER, HELICAL | FGO | Substantially Equivalent | |
| K914110 | GRASPING FORCEPS | FGO | Substantially Equivalent | |
| K913248 | CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K910603 | LOOP RETRIEVER | FFL | Substantially Equivalent | |
| K902265 | FLEXIBLE SNARE | FDI | Substantially Equivalent | |
| K896992 | METAL URETERAL BASKET STONE DISLODGER | FFL | Substantially Equivalent | |
| K896058 | GRASPING FORCEPS | KOA | Substantially Equivalent | |
| K896169 | METAL URETERAL BASKET STONE DISLODGER | FFL | Substantially Equivalent | |
| K895098 | BIOPSY FORCEPS | DWZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183873 | 2183873 | ANNEX MEDICAL, INC. | 6018 BLUE CIRCLE DR., Minnetonka, MN 55343 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DWZDevice, Biopsy, Endomyocardial
- FFLDislodger, Stone, Basket, Ureteral, Metal
- LQRDislodger, Stone, Biliary
- FGODislodger, Stone, Flexible
- FDXEndoscopic Cytology Brush
- FCLForceps, Biopsy, Non-Electric
- GCJLaparoscope, General & Plastic Surgery
- FDISnare, Flexible
- KOASurgical Instruments, G-U, Manual (And Accessories)
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 Annex Medical, Inc. 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