Panels › Cardiovascular › Product code OEZ · Class 2
Cardiovascular Procedure Kit
Regulation 870.1200
0510(k)s in 12 months (0 all time)
50recalls in 12 months (232 all time)
4recalls that name a 510(k)
Top companies in OEZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2024 | American Contract Systems, Inc. PACEMAKER PACK, SLCV01J; Medical convenience kit Open, Classified |
OEZ | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I;
b) ENDO KIT, Pack Number DYKE1558B;
c) ENDO KIT, Pack Open, Classified |
OEZ | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits labeled as:
1) PERMANENT PACING, Pack Number 00-400361J ;
2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;
3) PACEMAKER TRAY, Pack Number 00-401521F ;
4) FEMORAL Open, Classified |
OEZ | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) OPEN HEART PEDS, Pack Number CDS981050Q;
2) OPEN HEART CDS, Pack Number CDS982411N;
3) OPEN HEART, Pack Number CDS983348AA;
4) OPEN HEART, Pack Number CDS98 Open, Classified |
OEZ | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) HEART ANESTHESIA SET UP, REF DYNJ902752C,
b) KIT ENDO, REF DYKE1872A,
c) LOWER ENDO KIT, REF DYKE1921A,
d) PACEMAKER, REF DYNJ901681D,
e) UP Open, Classified |
OEZ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Customer Procedure Kit (Angiography/Angioplasty kit), REF:
K09T-01138
K09T-04484A
K09 Open, Classified |
OEZ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K11 (Custom Pressure Monitoring Kit), REF:
K11-00382C
To support fluid administratio Open, Classified |
OEZ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K09/K09T (Custom Manifold Kit), REF:
K09-00526L
K09-00807AH
K09-01467AD
K09-01467AF
K Open, Classified |
OEZ | None listed |
| Jul 10, 2024 | Cardinal Health 200, LLC Presource kits and trays, labeled as:
1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3;
2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4;
3) Cardiovascular Procedure Kit, Catal Open, Classified |
OEZ | None listed |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile convenience kits:
Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. Open, Classified |
OEZ | None listed |
| May 10, 2024 | MEDLINE INDUSTRIES, LP - Northfield namic CONVENIENCE KIT,
a) CAROTID MANIFOLD KIT, REF 60011045;
b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582;
c) LEFT HEART KIT, REF 60071822;
d) LEFT HEART KIT, REF 60080085 Open, Classified |
OEZ | None listed |
| Mar 29, 2024 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A
Part Number:
6375
16010
62974
65246
66312
66342
66388
66650
66852
70472
74307
74365
74366
74430
74475
74477
74502
74773
748 Open, Classified |
OEZ | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
a) DIALYSIS FISTULA KIT, REF DYNDC3106,
b) ENDO KIT, REF DYKE1346D,
c) ENDO KIT, REF DYKE1892A,
d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,
e) Open, Classified |
OEZ | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Procedural convenience kits and trays, cardiac, labeled as:
a) EP LAB BI V IMPLANT PACK, kit number AGBI64J;
b) LAB DEVICE IMPLANT, kit number AGDI40J;
c) LAB DEVICE IMPLANT, kit number AGDI40K;
Open, Classified |
OEZ | None listed |
| Nov 16, 2023 | ROi CPS LLC Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit Open, Classified |
OEZ | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Vasc. Open CVOR SJH, REF SJVO56B Open, Classified |
OEZ | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Pediatric Heart SJH, REF SJPH34K Open, Classified |
OEZ | None listed |
| Oct 10, 2023 | Cardinal Health 200, LLC Procedure packs:
(1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;
(2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.
(3 Open, Classified |
OEZ | 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. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902 Open, Classified |
OEZ | 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. OPEN HEART CDS-LF, Model Number: CDS840451L;
b. OPEN HEART LINE SET UP, Model Numb Open, Classified |
OEZ | 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. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;
b. EMANUEL EP TRAY, Model N Open, Classified |
OEZ | 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. AAA PACK, Model Number: DYNJ44847I;
b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ8 Open, Classified |
OEZ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G;
b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I;
c) Open, Classified |
OEZ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A;
b) EP PROCEDURE PACK, Model Number DYNJ67771;
c) EP PACK, Model Numb Open, Classified |
OEZ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K;
b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A;
c) SU Open, Classified |
OEZ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;
b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I Open, Classified |
OEZ | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827 Open, Classified |
OEZ | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. EP LAB PACEMAKER PACK
b. OPEN HEART CDS
c. OPEN HEART CDS
d. AAA CDS
e. OPEN HEART CDS
f. PACEMAKER CDS
g. HEART CDS
h. VALVE PACK
i. OPEN HEART Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein, Item No.682-577, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Endo Pack, Item No.682-509, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Medical Vein, Item No.682-330, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein, Item No.682-1732, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Phleb, Item No.682-1425, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, CATH PACK Item No.570-2789 Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, VEIN TRAY, Item No.570-2738, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Vein Clinics 1, Item No.570-1426 Open, Classified |
OEZ | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit Terminated |
OEZ | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures. Open, Classified |
OEZ | None listed |
| Jul 19, 2022 | ROi CPS LLC Nonsterile convenience kits:
(1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and
(2) regard Item #830019017, CV00214Q - CV. Terminated |
OEZ | None listed |
| Jun 28, 2022 | ROi CPS LLC regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. Terminated |
OEZ | None listed |
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