ClearanceBrief
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)
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Top companies in OEZ

DateFirm and productCodeLinked 510(k)
Sep 24, 2024American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kit
Open, Classified
OEZNone listed
Sep 11, 2024MEDLINE 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
OEZNone listed
Sep 6, 2024MEDLINE 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
OEZNone listed
Aug 28, 2024MEDLINE 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
OEZNone listed
Aug 22, 2024MEDLINE 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
OEZNone listed
Aug 12, 2024Merit 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
OEZNone listed
Aug 12, 2024Merit 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
OEZNone listed
Aug 12, 2024Merit 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
OEZNone listed
Jul 10, 2024Cardinal 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
OEZNone listed
Jun 28, 2024MEDLINE 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
OEZNone listed
May 10, 2024MEDLINE 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
OEZNone listed
Mar 29, 2024Terumo 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
OEZNone listed
Feb 25, 2024MEDLINE 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
OEZNone listed
Jan 26, 2024American 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
OEZNone listed
Nov 16, 2023ROi CPS LLC
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Open, Classified
OEZNone listed
Oct 26, 2023American Contract Systems, Inc.
Vasc. Open CVOR SJH, REF SJVO56B
Open, Classified
OEZNone listed
Oct 26, 2023American Contract Systems, Inc.
Pediatric Heart SJH, REF SJPH34K
Open, Classified
OEZNone listed
Oct 10, 2023Cardinal 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
OEZNone listed
Aug 3, 2023MEDLINE 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
OEZNone listed
Aug 3, 2023MEDLINE 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
OEZNone listed
Aug 3, 2023MEDLINE 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
OEZNone listed
Aug 3, 2023MEDLINE 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
OEZNone listed
Jul 20, 2023MEDLINE 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
OEZNone listed
Jul 20, 2023MEDLINE 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
OEZNone listed
Jul 20, 2023MEDLINE 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
OEZNone listed
Jul 20, 2023MEDLINE 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
OEZNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Open, Classified
OEZNone listed
Feb 6, 2023MEDLINE 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
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein, Item No.682-577,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein, Item No.682-1732,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Phleb, Item No.682-1425,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, CATH PACK Item No.570-2789
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
Open, Classified
OEZNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
Open, Classified
OEZNone listed
Nov 23, 2022ROi CPS LLC
regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Terminated
OEZNone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Open, Classified
OEZNone listed
Jul 19, 2022ROi CPS LLC
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Terminated
OEZNone listed
Jun 28, 2022ROi CPS LLC
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Terminated
OEZNone listed

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