Atrion Medical Products, Inc.
Arab, AL, US
ATRION MEDICAL PRODUCTS, INC. appears in FDA device records in Arab, AL. FDA records list 9 510(k) clearances between and , 11 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 9 510(k) clearances for Atrion Medical Products, Inc. between 1997 and 2006. The busiest year on record is 1997, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1998 | 2 |
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060643 | QL LOCKING SYRINGE | MAV | Substantially Equivalent | |
| K043249 | ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE | FMI | Substantially Equivalent | |
| K041158 | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM | CAZ | Substantially Equivalent | |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | Substantially Equivalent | |
| K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE | DXT | Substantially Equivalent | |
| K973633 | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET | OKS | Substantially Equivalent | |
| K973872 | ATRION MEDICAL COATED LACRIMAL INTUBATION SET | OKS | Substantially Equivalent | |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | KOE | Substantially Equivalent | |
| K971100 | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR | EIA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1043729 | 1043729 | ATRION MEDICAL PRODUCTS, INC. | 1426 CURT FRANCIS RD., ARAB, AL 35016 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPNAccessories, Soft Lens Products
- CAZAnesthesia Conduction Kit
- KTIBronchoscope Accessory
- HCGDevice, Neurovascular Embolization
- HNWDilator, Lachrymal
- KOEDilator, Urethral
- DXTInjector And Syringe, Angiographic
- LRCInstrument, Ent Manual Surgical
- OKSLacrimal Stents And Intubation Sets
- FQHLavage, Jet
- FMINeedle, Hypodermic, Single Lumen
- MAVSyringe, Balloon Inflation
- PTMSyringe, Balloon Inflation, Exempt
- EIAUnit, Operative Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain