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)
Top companies in OFT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Medline Industries, LP Convenience kits
ANESTHESIA PAIN PK LEAGUE
DYNJ67925A Open, Classified |
OFT | None listed |
| Sep 9, 2026 | Medical 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 |
OFT | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
PAIN PRE OP KIT
DYKS1476A Open, Classified |
OFT | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A Open, Classified |
OFT | None listed |
| Jun 29, 2026 | Medline 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 |
OFT | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
FEMORAL BLOCK TRAY
DYNJRA1739B Open, Classified |
OFT | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline CCI Nerve Block Tray
DYNJRA2742
Medline CPNB
DYNJRA2716 Open, Classified |
OFT | None listed |
| May 29, 2026 | B 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 |
OFT | None listed |
| May 29, 2026 | B 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 |
OFT | None listed |
| May 29, 2026 | B 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 |
OFT | None listed |
| May 28, 2026 | Medline 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 |
OFT | None listed |
| May 7, 2026 | Medline 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 |
OFT | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG Open, Classified |
OFT | None listed |
| Feb 17, 2026 | Medline 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 |
OFT | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713 Open, Classified |
OFT | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M Open, Classified |
OFT | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OFT | None listed |
| Mar 25, 2025 | MEDLINE 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 |
OFT | None listed |
| Jan 24, 2025 | B. 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 |
OFT | None listed |
| Dec 5, 2024 | MEDLINE 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 |
OFT | None listed |
| Nov 22, 2024 | MEDLINE 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 |
OFT | None listed |
| Oct 23, 2024 | MEDLINE 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 |
OFT | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H Open, Classified |
OFT | None listed |
| Aug 27, 2024 | MEDLINE 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 |
OFT | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield see RES for description Open, Classified |
OFT | None listed |
| Aug 8, 2024 | MEDLINE 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 |
OFT | None listed |
| Aug 3, 2023 | MEDLINE 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 |
OFT | None listed |
| Jul 20, 2023 | MEDLINE 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 |
OFT | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A Open, Classified |
OFT | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Tray, labeled as the following:
a. PAIN SERVICE PACK-LF;
b. LOCAL BASIC Open, Classified |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. CE18TKSTN CONT EPID W/SOFT TIP NRFIT
Catalog # 339191 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. CE18HKN ACCU-BLOC PERIFIX KIT NRFIT
Catalog # 339189 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. CE18TKN ACCU-BLOC PERIFIX KIT NRFIT
Catalog # 339188 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT
Catalog # 339187 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT
Catalog # 339186 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. CE17TKN CONT EPIDURALTUOHY NRFIT
Catalog # 339183 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. FEF 100N FLAT EPIDURAL FILTER NRFIT
Catalog # 339160 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. ES1827KN SPINAL/EPIDURAL TRAY NRFIT
Catalog # 339115 Terminated |
OFT | None listed |
| Jul 10, 2019 | B. Braun Medical, Inc. ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT
Catalog # 339114 Terminated |
OFT | None listed |
| Dec 12, 2016 | Becton 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 |
OFT | None listed |
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