Pajunk Medical Systems
Alpharetta, GA, US
PAJUNK MEDICAL SYSTEMS appears in FDA device records in Alpharetta, GA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004076349 | 3004076349 | PAJUNK MEDICAL SYSTEMS | 4575 Marconi Dr., Alpharetta, GA 30005 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OGDCustom Anesthesia Tray
- HCCDevice, Biofeedback
- OGEEpidural Anesthesia Kit
- KDCInstrument, Surgical, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- OGJNerve Block Tray
- OFUSpinal Anesthesia Kit
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- GZIStimulator, Neuromuscular, External Functional
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0278-2023 | PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000. | The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain