ClearanceBrief
Panels › Anesthesiology › Product code OFT · Class 2

Spinal Epidural Anesthesia Kit

Regulation 868.5120

0510(k)s in 12 months (0 all time)
16recalls in 12 months (40 all time)
0recalls that name a 510(k)
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Top companies in OFT

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Medline Industries, LP
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
Open, Classified
OFTNone listed
Sep 9, 2026Medical Action Industries, Inc. 306
Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Open, Classified
OFTNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
Open, Classified
OFTNone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Open, Classified
OFTNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE T
Open, Classified
OFTNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
Open, Classified
OFTNone listed
Jun 12, 2026Medline Industries, LP
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
Open, Classified
OFTNone listed
May 29, 2026B Braun Medical Inc
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No
Open, Classified
OFTNone listed
May 29, 2026B Braun Medical Inc
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Comp
Open, Classified
OFTNone listed
May 29, 2026B Braun Medical Inc
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH
Open, Classified
OFTNone listed
May 28, 2026Medline Industries, LP
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3
Open, Classified
OFTNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:
Open, Classified
OFTNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
Open, Classified
OFTNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Numbe
Open, Classified
OFTNone listed
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Open, Classified
OFTNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Open, Classified
OFTNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
Open, Classified
OFTNone listed
Mar 25, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
Open, Classified
OFTNone listed
Jan 24, 2025B. Braun Medical, Inc.
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Open, Classified
OFTNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
Open, Classified
OFTNone listed
Nov 22, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL B
Open, Classified
OFTNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
Open, Classified
OFTNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Open, Classified
OFTNone listed
Aug 27, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Nu
Open, Classified
OFTNone listed
Aug 27, 2024MEDLINE INDUSTRIES, LP - Northfield
see RES for description
Open, Classified
OFTNone listed
Aug 8, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4
Open, Classified
OFTNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, M
Open, Classified
OFTNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE
Open, Classified
OFTNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Open, Classified
OFTNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Open, Classified
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
Terminated
OFTNone listed
Jul 10, 2019B. Braun Medical, Inc.
ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
Terminated
OFTNone listed
Dec 12, 2016Becton Dickinson & Company
BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
Terminated
OFTNone listed

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