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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)
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Top companies in OGE

DateFirm and productCodeLinked 510(k)
Oct 1, 2026Custom 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
OGENone listed
Jul 27, 2026Windstone 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
OGENone listed
May 29, 2026B 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
OGENone listed
May 29, 2026B 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
OGENone listed
May 29, 2026B 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
OGENone listed
May 29, 2026B 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
OGENone listed
May 28, 2026Medline 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
OGENone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Open, Classified
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Oct 9, 2025B 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
OGENone listed
Nov 22, 2024MEDLINE 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
OGENone listed
Sep 6, 2024MEDLINE 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
OGENone listed
Aug 27, 2024MEDLINE INDUSTRIES, LP - Northfield
See RES Description
Open, Classified
OGENone listed
Feb 16, 2024B. 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
OGENone listed
Feb 16, 2024B. 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
OGENone listed
Sep 21, 2023B. Braun Medical, Inc.
Perifix / Epidural anesthesia set, medicated
Open, Classified
OGENone listed
Jun 23, 2023B. Braun Medical, Inc.
Design Options / Epidural anesthesia kit (10 count carton)
Open, Classified
OGENone listed
Jun 23, 2023B. Braun Medical, Inc.
Perifix / Epidural anesthesia kit (10 count carton)
Open, Classified
OGENone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Open, Classified
OGENone listed
Nov 23, 2022Pajunk 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
OGENone listed
Jul 24, 2017Epimed International
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Terminated
OGEK030562
Jul 24, 2017Epimed 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
OGEK041843
Jul 24, 2017Epimed 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
OGEK053318

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