Panels › Cardiovascular › Product code OEZ · Class 2
Cardiovascular Procedure Kit
Regulation 870.1200
0510(k)s in 12 months (0 all time)
49recalls in 12 months (231 all time)
4recalls that name a 510(k)
Top companies in OEZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) OPEN HEART CDS, Medline product number/SKU CDS840094R;
2) OPEN HEART CDS, Medline product number/SKU CDS840171AG;
3) MHC AV FISTULA, Medline produc Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ROBOTIC PROSTATECTOMY PACK;
Model/Item Number (Kit): NAMC423-11; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. PACK OPEN HEART CFH;
Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ENDOVASCULAR PACK;
Model/Item Number (Kit): VAPX014-04; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ADULT HEART TRAY SHANDS JACKS;
Model/Item Number (Kit): SHND419-08; Open, Classified |
OEZ | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
CARDIAC HEART BUNDLE NS
Model No. LMCH99P
OPEN HEART 2 RCH 0248495
Model No. RCOH62C Open, Classified |
OEZ | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OPEN HEART ADULT, Catalog Number: CDS840396Y;
2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O;
3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080 Open, Classified |
OEZ | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540;
2) KIT, GVI OPEN HEART A B , Catalog Number: Open, Classified |
OEZ | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
OPEN HEART
CDS983348AA
CDS983348AB Open, Classified |
OEZ | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) CDS840396X, Catalog Number: CDS840396X;
2) CDS840396Y, Catalog Number: CDS840396Y;
3) CDS983348AA, Catalog Number: CDS983348AA;
4) CDS983348AB, Catalog Number: CDS98334 Open, Classified |
OEZ | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) OPEN HEART PACK, Medline Kit SKU CDS840393P;
2) OPEN HEART PACK, Medline Kit SKU CDS840393Q;
3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W;
4) VALVE Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM Open, Classified |
OEZ | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB Open, Classified |
OEZ | None listed |
| Jul 31, 2026 | AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
HEART CATH, SELF REGIONAL
SELF131-05 Open, Classified |
OEZ | None listed |
| Jul 30, 2026 | Medical Action Industries, Inc. 306 Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds Open, Classified |
OEZ | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline medical convenience kits labeled as:
1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B;
2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A. Open, Classified |
OEZ | None listed |
| Jul 10, 2026 | Argon Medical Devices, Inc Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A Open, Classified |
OEZ | None listed |
| Jul 8, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;
2) ACCESSORY KIT, Model Number: DYNJ901348F Open, Classified |
OEZ | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF;
2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE;
3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK Open, Classified |
OEZ | None listed |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
CABG A CDS
CDS982269K
CDS982269L
CDS982269M
CDS982269N
CARDIAC MAJOR
DYNJ901328D
DYNJ901328F
HEART A
DYNJ903465F
DYNJ90 Open, Classified |
OEZ | None listed |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
CARDIAC MAJOR
DYNJ901328G
HEART A
DYNJ903465K
OPEN HEART
DYNJ909090G
SILVER CROSS OPEN HEART
DYNJ906102M
VPH OPEN HEA Open, Classified |
OEZ | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
ABDOMINAL VASCULAR-LF
DYNJ905291B
DYNJ905291C
ARTERIOGRAM
DYNJ28082G
CVICU HEART BAG
DYKM2130A
ENDOVASCULA Open, Classified |
OEZ | None listed |
| Jun 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OPEN HEART CDS, Model Number: CDS840144Q;
2) OPEN HEART, Model Number: CDS840150W;
3) OPEN HEART ADULT, Model Number: CDS840396AA;
4) CABG A CDS, Model Number: CDS9822 Open, Classified |
OEZ | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products) Open, Classified |
OEZ | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB;
AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC;
ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1;
ARROW(R) VPS(R) ACCESS KIT/ASK Open, Classified |
OEZ | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
BIB AV FISTULA PACK
DYNJ58304B
CARDIAC MINOR SURGICOUNT PACK
DYNJ56573B
ENDOVASCULAR PACK
DYNJ29135N
EP DEVICE
DYNJ65916B
FULL LINE ANEURYSM CDS
CDS983672P
GEN FEM POP Open, Classified |
OEZ | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
LOOP PACK
DYNJ61460C
OPEN HEART
CDS840150Y
PACEMAKER
DYNJ56297C
PACEMAKER PK
DYNJT3454
PACEMAKER/ICD PACK
DYNJ33822L
PAD OPEN HEART
DYNJ900962O
PEDIATRIC OPEN HEART
DY Open, Classified |
OEZ | None listed |
| May 8, 2026 | Medline Industries, LP 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544;
2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351;
3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M;
4. ANGIO DRAPE CARDIAC PA Open, Classified |
OEZ | None listed |
| May 7, 2026 | Medline Industries, LP See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP C Open, Classified |
OEZ | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. Open, Classified |
OEZ | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. Open, Classified |
OEZ | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI;
2. OPEN HEART CDS, Medline Kit Number/SKU CDS9848 Open, Classified |
OEZ | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
TAVR PACK DYNJ69246B
ABDOMINAL VASCULAR-LF DYNJ905291D
ANGIOGRAPHIC PACK DYNJ86769
AORTAGRAM PACK DYNJ26783 Open, Classified |
OEZ | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775;
2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026;
3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;
Open, Classified |
OEZ | None listed |
| Apr 7, 2026 | Medline Industries, LP NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline S Open, Classified |
OEZ | None listed |
| Apr 1, 2026 | Medline Industries, LP THORACIC ROBOTS, DYNJ908777B Open, Classified |
OEZ | None listed |
| Mar 12, 2026 | Medline Industries, LP Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit:
1) OPEN HEART, Model Number: DYNJ902487A;
2) CARDIAC PROCEDURE, Model Number: DYNJ908126;
3) CARDIO CONGENITO, Model Number: Open, Classified |
OEZ | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OPEN HEART CDS, Model Number: CDS840015AQ;
2) OPEN HEART CDS, Model Number: CDS840023T;
3) OFF PUMP CABG CDS, Model Number: CDS840087AI;
4) OFF PUMP CABG CDS, Model Num Open, Classified |
OEZ | None listed |
| Feb 9, 2026 | Medline Industries, LP Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108 Open, Classified |
OEZ | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A;
2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L;
3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B;
4) Open, Classified |
OEZ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical , Custom Manifold Kit
REF: K09-13203A Open, Classified |
OEZ | None listed |
| Jan 14, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) THORACIC ROBOTICS, REF DYNJ908777B;
2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359 Open, Classified |
OEZ | None listed |
| Jan 12, 2026 | Medline Industries, LP Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;
2) OPEN HEART CDSKit SKU CDS984355K;
3) BAG A OPEN Open, Classified |
OEZ | None listed |
| Dec 5, 2025 | Medline Industries, LP MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C Open, Classified |
OEZ | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) GENERAL AAA #11-RF, REF CDS840261AB;
2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;
3) PERIPHERAL VASCULAR CDS, REF CDS983723J;
4) ACH OPEN HEART, REF C Open, Classified |
OEZ | None listed |
| Nov 13, 2025 | Medline Industries, LP Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;
OPEN HEART SUPPLEMENT
DYNJ909116D;
VASCULAR
DYNJ909124F Open, Classified |
OEZ | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
ANCV78BC HEART PACK - 205947
HGCV05K CV SET UP PACK
MHPP97AR PACEMAKER PACK- 206010
UDBH37AW BASIC HEART PACK - 206044
UHPP82AH PERIPHERAL PACK - 209 Open, Classified |
OEZ | None listed |
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