Company ยท US
Puritan Medical Products, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2025 | K242820 | Puritan PurSafe Plus Collection and Transport System Puritan Medical Products, LLC | QBD |
| Nov 4, 2016 | K162284 | Puritan Fecal Opti-Swab Collection and Transport System Puritan Medical Products, LLC | JSM |
| Jul 29, 2016 | K160082 | Puritan Opti-Tranz Cary-Blair Collection and Transport System Puritan Medical Products, LLC | JSM |
| Jan 9, 2015 | K142366 | Puritan OptiTranz Liquid Stuart Collection and Transport System Puritan Medical Products, LLC | JSM |
| Oct 21, 2013 | K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM Puritan Medical Products, LLC | LIO |
| Jun 8, 2012 | K120846 | TRANSPORT CULTURE MEDIUM DEVICE Puritan Medical Products, LLC | LIO |
| Mar 1, 2012 | K113249 | TRANSPORT CULTURE MEDIUM DEVICE Puritan Medical Products, LLC | JSM |
| Jan 19, 2012 | K111681 | HISTOBRUSH Puritan Medical Products Company, LLC | HHT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2024 | Puritan Medical Products Company, Llc HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. Open, Classified |
KXG | None listed |
| Mar 13, 2015 | Puritan Medical Products Co., LLC Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT.
Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient. Terminated |
KXG | None listed |
| Jul 20, 2004 | Puritan Medical Products Inc MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No. 536053-009, Reference Gas, containing Oxygen 21% plus/minus 0.02% Absolute, and Nitrogen: Bal Terminated |
BXH | None listed |