Panels › Anesthesiology › Product code OGE · Class 2
Epidural Anesthesia Kit
Regulation 868.5120
0510(k)s in 12 months (0 all time)
8recalls in 12 months (34 all time)
3recalls that name a 510(k)
Top companies in OGE
| Company | 510(k)s | Recalls |
|---|---|---|
| B BRAUN MEDICAL INC | 0 | 22 |
| Epimed International | 0 | 3 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 3 |
| Medline Industries, LP | 0 | 2 |
| Custom Interventional Pain Management, LLC | 0 | 1 |
| Pajunk Medical Systems, L.P. | 0 | 1 |
| Stradis Medical, LLC dba Stradis Healthcare | 0 | 1 |
| Windstone Medical Packaging, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Custom Interventional Pain Management, LLC Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM
Product Name: Mastisol Skin Adhesive
Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuo Open, Classified |
OGE | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;
2) Single Shot Epidural Tray - RX, Part Number AMS11296A;
3) N Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: CESK SHANDS JACKSONVILLE 20055717
Model/Catalog Number: 555884
Software Version: N/A
Product Description: CESK SHANDS JACKSONVILLE 20055717
Component: N Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: CESK RIVERSIDE HEALTH SYSTEM
Model/Catalog Number: 552126
Software Version: N/A
Product Description: CESK RIVERSIDE HEALTH SYSTEM
Component: No Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: CESK HARRIS METHODIST
Model/Catalog Number: 555498
Software Version: N/A
Product Description: CESK HARRIS METHODIST
Component: No Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC
Product Name: CESK NORTHSIDE ANESTHESIA TRAY
Model/Catalog Number: 555076
Software Version: N/A
Product Description: CESK NORTHSIDE ANESTHESIA TRAY
Component: No Open, Classified |
OGE | None listed |
| May 28, 2026 | Medline Industries, LP Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245;
2) SPINAL TRAY W/PENCIL POINT NDL, Medline Ki Open, Classified |
OGE | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions:
1. CESK ROBERT WOOD JOHNSON UNIV HOSP.
2. CESK EAST JEFFERSON GEN HOSP 20071769.
3. CESK FLETCHER A Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound E Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions:
1. SESK PARKLAND MEMORIAL FX CSE TRAY.
2. SESK OWENSBORO DAVIESS HOSP 20058814.
3. SESK MEMORIAL HEALTH SYSTEM SPINA Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidur Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Pro Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17T Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE1 Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17 Open, Classified |
OGE | None listed |
| Oct 9, 2025 | B BRAUN MEDICAL INC PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Pro Open, Classified |
OGE | None listed |
| Nov 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE procedure kits labeled as follows:
1) 20G EPI CATH SINGLE STERILE, REF EPICATH19
2) 20G EPI CATH SINGLE STERILE, REF EPICATH20 Open, Classified |
OGE | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ;
2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004;
3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0 Open, Classified |
OGE | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield See RES Description Open, Classified |
OGE | None listed |
| Feb 16, 2024 | B. Braun Medical, Inc. Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit)
A collection of devices intended for the administration of an analgesic or anesthetic agent to the epid Open, Classified |
OGE | None listed |
| Feb 16, 2024 | B. Braun Medical, Inc. Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip
Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration Open, Classified |
OGE | None listed |
| Sep 21, 2023 | B. Braun Medical, Inc. Perifix / Epidural anesthesia set, medicated Open, Classified |
OGE | None listed |
| Jun 23, 2023 | B. Braun Medical, Inc. Design Options / Epidural anesthesia kit (10 count carton) Open, Classified |
OGE | None listed |
| Jun 23, 2023 | B. Braun Medical, Inc. Perifix / Epidural anesthesia kit (10 count carton) Open, Classified |
OGE | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 Open, Classified |
OGE | None listed |
| Nov 23, 2022 | Pajunk Medical Systems, L.P. 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% So Terminated |
OGE | None listed |
| Jul 24, 2017 | Epimed International TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only Terminated |
OGE | K030562 |
| Jul 24, 2017 | Epimed International COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile Terminated |
OGE | K041843 |
| Jul 24, 2017 | Epimed International RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter Terminated |
OGE | K053318 |
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