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 10, 2023 | Cardinal Health 200, LLC Procedure packs:
(1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;
(2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;
(3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;
(4) Preso Open, Classified |
OJG | 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. ANGIO, Model Number: DYNJ905151A;
b. ANGIO/VENO PACK, Model Number: DYNJ58346A;
Open, Classified |
OJG | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G;
b) DBS PACK-LF, Model Number DYNJ0878178J;
c) DBS PA Open, Classified |
OJG | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kits:
1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack;
2. regard Item Number: 880411008, NU01018H - Lumbar Universal ;
3. regard Item Number Open, Classified |
OJG | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. AV SHUNT CDS
b. ZALE V-P SHUNT CDS
c. NEURO CDS-LF
d. MAJOR NEURO
e. NEURO PACK-LF
f. CUSTOM NEURO PACK-LF
g. NEURO PACK-LF
h. NEURO PACK-LF
i Open, Classified |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit Terminated |
OJG | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various neurology packs Open, Classified |
OJG | None listed |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEUR Open, Classified |
OJG | None listed |
| Mar 22, 2022 | American Contract Systems, Inc. 1) ACS Spine Pack
2) ACS Lumbar/Back Set Up Tray Open, Classified |
OJG | None listed |
| Feb 25, 2022 | Stradis Medical, LLC dba Stradis Healthcare Surgicare Neuro Pack - Neurological Kit Open, Classified |
OJG | None listed |
| Jan 21, 2022 | Integra LifeSciences Corp. Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures.
Part Number: 82661 Terminated |
OJG | None listed |
| Jan 21, 2022 | Integra LifeSciences Corp. Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures.
Product umber: 826 Terminated |
OJG | None listed |
| Oct 27, 2021 | Medline Industries Inc Neuro Convenience Kit Terminated |
OJG | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
OJG | None listed |
| Feb 18, 2020 | Avid Medical, Inc. Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Terminated |
OJG | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9002256
NEUROSURGERY PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001300
NEURO-SPINE SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Sep 3, 2015 | Customed, Inc NEURO PACK 2/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OJG | None listed |
| Sep 3, 2015 | Customed, Inc NEURO SPINE PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OJG | None listed |
| Sep 3, 2015 | Customed, Inc NEURO PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OJG | None listed |
| Dec 16, 2014 | Customed, Inc Neuro Pack, Catalog # 900-752
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Dec 16, 2014 | Customed, Inc ACDF Pack, catalog #900-2917
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Dec 16, 2014 | Customed, Inc Neuro Pack, catalog #900-2256
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Dec 16, 2014 | Customed, Inc Neuro Spine Pack, Catalog number 900-1300
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Dec 16, 2014 | Customed, Inc Neuro Pack, Catalog number 900-1146.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc ACDFPACK
SURGICAL CENTER, CODE 900-2917.
CONTENTS:
(1) SOLUTION SURGICAL DURAPREP 6ML LIF
(4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF
(3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF
(3) TOWELS ABSO Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc NEURO SPINE PACK
, CODE 900-2765
CONTENTS:
(l ) DRAPE INCISION 23" X 1 7"
(I) SCALPEL W/HANDLE # 15 S/STEEL
(I) INSTRUMENT POUCH 7 X 1 1 2 COMPART
(I) Pk. STRIP SURGICAL W' X 6"
(I) CA Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc NEURO PACK
CONTENTS:
(4) TOWEL ABSOSRBENT 15" X 20" LIF
( I ) BAG BI OH AZARD 30" X 37"
(2) MAYO STAND COYER REINFORCED UF
(20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF
( I ) CAUTERY POLISHER TIP L Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc NEURO SPINE PACK
CONTENTS: (1) SUTURE BAG FLORAL LIF
(1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF
(1) Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc NEURO SPINE PACK -
(1) BAG SUTURE FLORAL
(1) COVER TABLE 44" X 90"
(4) ABSORBENT TOWELS 15" X 20" UF
(1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS
(4) DRAPE UTILITY WITH TAPE LIF
(3) GOWN IMP. Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc NEURO PACK -
(1) CAUTERY TIP POLISHER LIF
(4) DRAPE UTILITY WITH TAPE LIF
(1) INSTRUMENT POUCH
(10) LAP SPONGE PRE-WASH XRD
(1) Pk. SURGICAL STRIP W' X 6"
(2) UTILITY BOWL 32oz
(1) MAYO TRAY LARGE
(9 Terminated |
OJG | None listed |
| Aug 29, 2014 | Customed, Inc NEURO PACK-
(1)TABLE COVER 44" x 90"
(1) GOWN SURGEON REINFORCED X-LARGE TIWRAP
(1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS
(1) BAG SUTURE FLORAL
(1) MAYO STAND COVER REINFORCED LIF
(2) TOWELS ABSORBE Terminated |
OJG | None listed |
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