Neurological Tray
Regulation 882.4525
0510(k)s in 12 months (0 all time)
24recalls in 12 months (94 all time)
1recalls that name a 510(k)
Top companies in OJG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A;
2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M. Open, Classified |
OJG | None listed |
| Oct 7, 2026 | AVID Medical, Inc. CRANIOTOMY PACK;
Model/Item Number (Kit): WRNM035-20; Open, Classified |
OJG | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I;
2) NEURO PACK-LF, Catalog Number: DYNJ41246F;
3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A;
4) MAJOR NEURO Open, Classified |
OJG | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM;
2) KIT, ORP MAJOR SPINE , Catalog Number: Open, Classified |
OJG | None listed |
| Aug 28, 2026 | AVID Medical, Inc. 1) NEURO, (kit) ACNE73-01;
2) NEURO, (kit) ACNE73-03;
3) CRANI, (kit) AKCR19-01;
4) ORTHO SPINE PACK, (kit) ARMC017;
5) BMHM NEURO PACK, (kit) BMHT016-05;
6) LUMBAR PACK, (kit) BMHT112-03;
7) NE Open, Classified |
OJG | None listed |
| Aug 21, 2026 | Medline Industries, LP Medline medical convenience kits, labeled as:
1) NEURO CDS, Medline Kit SKU CDS985246J;
2) NEURO PACK, Medline Kit SKU DYNJ32770V;
3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D;
4) NEURO PACK-LF Open, Classified |
OJG | None listed |
| Aug 20, 2026 | American Contract Systems Inc American Contract Systems medical procedure kits and trays labeled as:
1) CRANI PACK - 208400, Model Item Number UDCP57AI;
2) SPINE PACK, Model Item Number HSLM53AC;
3) CRANIAL PACK - 205992, Mode Open, Classified |
OJG | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27;
2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28;
3) CHI STD NEURO CRANI OPT 2 , Catal Open, Classified |
OJG | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414 Open, Classified |
OJG | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Neuro Pack, Pack Number AMS12195C;
2) Neuro Pack, Pack Number AMS12195D;
3) Neuro Pack, Pack Number AMS12307;
4) Neuro Spine Open, Classified |
OJG | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline medical convenience kits labeled as:
NEURO PACK, Medline Kit SKU DYNJ59397P Open, Classified |
OJG | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
ANGIOGRAPHY PACK-LF
DYNJ0854485S
DEEP BRAIN STIMULATION PACK
DYNJ0842793G
NEURO ACCESSORY PACK
DYNJ55385A
Open, Classified |
OJG | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G;
2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J;
3) VP SHUNT CDS, Medline Kit Number/SKU CDS Open, Classified |
OJG | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kit:
BHS NEURO
DYNJ904900N
MEDTRX NEURO PACK
DYNJ67267B
MRI DBS PACK
DYNJ9814630O
NEURO CDS-LF
CDS983383L
NEURO PACK
DYNJ59397Q
DYNJT7315
NEURO PACK-LF
DYNJ25097I
NEURO VP S Open, Classified |
OJG | None listed |
| May 8, 2026 | Medline Industries, LP Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C Open, Classified |
OJG | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;
2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;
3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;
4) KIT NE Open, Classified |
OJG | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO, Open, Classified |
OJG | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ANGIO KIT PACK DYNJ50783B
ANGIO PHC DYNJ37485C
C.I.C.N. ANGIO PACK DYNJ53064B
FHT P NEURO PACK DYNJ39931D Open, Classified |
OJG | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) ARTHROGRAM TRAY, Model Number: DYNJ07425;
2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I
3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A
4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53 Open, Classified |
OJG | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. ANGIO PACK, Medline SKU # DYNJ57032D;
2. NEURO INT Open, Classified |
OJG | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;
2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;
3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;
4) KIT NE Open, Classified |
OJG | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L;
2) NEURO MINOR PACK, Kit SKU DYNJ46546M;
3) NEURO SHUNT PACK, Kit SKU DYNJ54396K;
4) NEURO PAC Open, Classified |
OJG | None listed |
| Jan 12, 2026 | Medline Industries, LP Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
NEURO ANGIO PACK, Medline kit SKU DYNJ38935 Open, Classified |
OJG | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) BASIC NEURO PACK, REF CDS780202R;
2) ACDF CDS, REF CDS941061M;
3) NEURO PACK-LF, REF DYNJ0038440C;
4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S;
5) NE Open, Classified |
OJG | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
HSLM53AB SPINE PACK
MILM82A DTC LAMINECTOMY PACK (PS 209475)
RCNA47B NEURO ANGIO 0246971
SFLM54AB LAMINECTOMY PACK - 219659
UDLM94AA LAMINECTOMY PACK Open, Classified |
OJG | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W;
2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V. Open, Classified |
OJG | None listed |
| May 31, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits containing Codman Disposable Perforator 14 mm:
CRANIOTOMY, SKU DYNJ35349C Open, Classified |
OJG | K213481 |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) NEURO PACK WRO-LF, Model Number: DYNJ41856C;
2) STIM IMPLANT PACK, Model Number: DYNJ53032C;
3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629 Open, Classified |
OJG | None listed |
| Mar 26, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B;
2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W;
3) NEURO ANGIO PACK, Pack Number DYNJ83941;
4) NEURO ANGIO PAC Open, Classified |
OJG | None listed |
| Mar 20, 2025 | American Contract Systems Inc CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. Open, Classified |
OJG | None listed |
| Mar 14, 2025 | American Contract Systems Inc SPINE LUMBAR PACK
, Model No UTSL72AA
UTSL72AB Open, Classified |
OJG | None listed |
| Mar 14, 2025 | American Contract Systems Inc NEURO IR TRAY
, Model No WENI56J Open, Classified |
OJG | None listed |
| Mar 14, 2025 | American Contract Systems Inc DIAGNOSTIC NEURO IR TRAY
, Model No WENE21 Open, Classified |
OJG | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12;
2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13
3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 Open, Classified |
OJG | None listed |
| Jan 15, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12;
2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42;
3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43;
Open, Classified |
OJG | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield See DocMan Open, Classified |
OJG | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T;
2) NEURO KIT, SKU CDS981327Q;
3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I;
4) A Open, Classified |
OJG | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) BASIC NEURO PACK, REF CDS780202P;
2) BASIC NEURO PACK, REF CDS780202Q;
3) BASIC NEURO PACK, REF CDS780202R;
4) ACDF CDS, REF CDS941061M;
5) NEURO KIT, REF Open, Classified |
OJG | None listed |
| Nov 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE procedure kits labeled as follows:
1) NEURAXIAL KIT, REF PAIN1876A Open, Classified |
OJG | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
a) NEURO PACK, REF DYNJ37909A;
b) SHUNT PACK, REF DYNJ40040C Open, Classified |
OJG | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Neuro Vascular, ANKV91A; Medical convenience kit Open, Classified |
OJG | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B Open, Classified |
OJG | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA;
2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ;
3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S Open, Classified |
OJG | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B;
2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137 Open, Classified |
OJG | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
NEURO TRAY, Pack Number DYNJ55909B Open, Classified |
OJG | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) BASIC NEURO, REF DYNJ909171A;
b) NEURO, REF DYNJ905510D;
c) NEURO, REF DYNJ902388L;
d) NEURO SAS, REF DYNJ908566 Open, Classified |
OJG | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Spine Pack convenience kit Open, Classified |
OJG | None listed |
| Jul 10, 2024 | Cardinal Health 200, LLC Presource kits and trays, labeled as:
1) Neurological Tray, Catalog Number SAN29NICCA;
2) Neurological Tray, Catalog Number SAN29NRCC1;
3) Neurological Tray, Catalog Number SAN29NRCC2;
4) Neurolo Open, Classified |
OJG | None listed |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Sterile surgical convenience kit:
Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. Open, Classified |
OJG | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, general hospital use, labeled as:
a) IR NEURO PACK, kit number AGNE20J;
b) ADULT CRANIOTOMY PACK, kit number LLCR99;
c) LAMINECTOMY PACK, kit number L Open, Classified |
OJG | None listed |
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