| Reported | Recall | Class | Product | Firm |
|---|
| 2021-05-26 | Z-1615-2021 | Class II | Medtronic REF: MMT-7020D4 Guardian Sensor | Medtronic Inc. |
| 2021-05-26 | Z-1616-2021 | Class II | Medtronic REF: MMT-7020D5 Guardian Sensor | Medtronic Inc. |
| 2021-05-26 | Z-1617-2021 | Class II | Medtronic | Medtronic Inc. |
| 2021-05-26 | Z-1618-2021 | Class II | Medtronic | Medtronic Inc. |
| 2021-05-26 | Z-1621-2021 | Class II | ELUVIA Drug-Eluting Vascular Stent System | Boston Scientific Corporation |
| 2021-05-26 | Z-1622-2021 | Class II | Bioseal | Bioseal Corporation |
| 2021-05-26 | Z-1623-2021 | Class II | Bioseal | Bioseal Corporation |
| 2021-05-26 | Z-1624-2021 | Class II | Bioseal | Bioseal Corporation |
| 2021-05-26 | Z-1631-2021 | Class II | BPB medica CEMIX | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1632-2021 | Class II | RENOVA SPINE BONE FILLER 10G 12CM CENTIM | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1633-2021 | Class II | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1634-2021 | Class II | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1635-2021 | Class II | CEMENT MIXING SYSTEM | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1636-2021 | Class II | EASYNJECT | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1637-2021 | Class II | 10 GAUGE DIRECT UNILATERAL STYLET | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1638-2021 | Class II | 10 GAUGE CEMENT DELIVERY CANNULA | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1639-2021 | Class II | 10G DIRECT SINGLE | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1640-2021 | Class II | 8G DIRECT WORKING CANNULA BEVEL TIP | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1641-2021 | Class II | 11G DIRECT SINGLE | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1642-2021 | Class II | CEMIX | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1643-2021 | Class II | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1644-2021 | Class II | 11G DIRECT SINGLE | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1645-2021 | Class II | 8G DIRECT WORKING CANNULA BEVEL TIP | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1646-2021 | Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1647-2021 | Class II | 10G DIRECT WORKING CANNULA BEVEL TIP 15CM | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1648-2021 | Class II | 10G COAXIAL CANNULA WITH TUOHY CONNECTION | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1649-2021 | Class II | 10 GAUGE DRILL | BIOPSYBELL S.R.L. |
| 2021-05-26 | Z-1650-2021 | Class II | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-26 | Z-1652-2021 | Class II | REF 7617400 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1653-2021 | Class II | REF 7617405J | Bard Access Systems Inc. |
| 2021-05-26 | Z-1654-2021 | Class II | REF 7617408 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1655-2021 | Class II | REF 7617408D | Bard Access Systems Inc. |
| 2021-05-26 | Z-1656-2021 | Class II | REF 7655405 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1657-2021 | Class II | REF 7655405J | Bard Access Systems Inc. |
| 2021-05-26 | Z-1658-2021 | Class II | REF 7812400 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1659-2021 | Class II | REF 9617405 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1660-2021 | Class II | REF 9617407 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1661-2021 | Class II | REF 9617408 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1662-2021 | Class II | REF 9617408D | Bard Access Systems Inc. |
| 2021-05-26 | Z-1663-2021 | Class II | REF 9655405 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1664-2021 | Class II | REF 69655405 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1665-2021 | Class II | REF 91660417 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1666-2021 | Class II | REF CK000379 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1667-2021 | Class II | REF CK000516 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1668-2021 | Class II | REF 7617405 | Bard Access Systems Inc. |
| 2021-05-26 | Z-1669-2021 | Class II | REF 7617407 | Bard Access Systems Inc. |
| 2021-05-19 | Z-1530-2021 | Class I | ASSURITY Pulse Generator REF PM**** SN ********* ST | St. Jude Medical, Cardian Rhythm Management Division |
| 2021-05-19 | Z-1531-2021 | Class I | ENDURITY Pulse Generator REF PM**** SN ********* St | St. Jude Medical, Cardian Rhythm Management Division |
| 2021-05-19 | Z-1536-2021 | Class II | AquaBplus and AquaBplus B2 Water Purification System | Fresenius Medical Care Holdings, Inc. |
| 2021-05-19 | Z-1540-2021 | Class II | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse… | Meridian Bioscience Inc |
| 2021-05-19 | Z-1541-2021 | Class II | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs… | Meridian Bioscience Inc |
| 2021-05-19 | Z-1542-2021 | Class II | Regard Dressing Change Tray | ROi CPS LLC |
| 2021-05-19 | Z-1543-2021 | Class I | Alaris Pump Module | STEP-HAR MEDICAL LLC |
| 2021-05-19 | Z-1544-2021 | Class I | Alaris Pump Module | Infusion Pump Repair |
| 2021-05-19 | Z-1545-2021 | Class II | NM/CT 850 Nuclear Medicine / CT Scanners | GE Healthcare, LLC |
| 2021-05-19 | Z-1546-2021 | Class II | NM/CT 860 Nuclear Medicine / CT Scanners | GE Healthcare, LLC |
| 2021-05-19 | Z-1547-2021 | Class II | NM/CT 870 DR Nuclear Medicine / CT Scanners | GE Healthcare, LLC |
| 2021-05-19 | Z-1548-2021 | Class II | Provox Life Night HME | Atos Medical AB |
| 2021-05-19 | Z-1549-2021 | Class II | NeuroTherm NT2000iX Radiofrequency | Abbott Laboratories Inc. (St Jude Medical) |
| 2021-05-19 | Z-1550-2021 | Class II | PowerPort duo M | Bard Peripheral Vascular Inc |
| 2021-05-19 | Z-1551-2021 | Class II | PowerPort duo M | Bard Peripheral Vascular Inc |
| 2021-05-19 | Z-1552-2021 | Class II | PowerPort duo M | Bard Peripheral Vascular Inc |
| 2021-05-19 | Z-1553-2021 | Class II | ReWalk Personal 6 | Argo Medical Technologies Ltd |
| 2021-05-19 | Z-1554-2021 | Class I | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical Action Industries, Inc. 306 |
| 2021-05-19 | Z-1555-2021 | Class I | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical Action Industries, Inc. 306 |
| 2021-05-19 | Z-1556-2021 | Class I | Kit: Midline Insertion DA | Medical Action Industries, Inc. 306 |
| 2021-05-19 | Z-1557-2021 | Class I | Kit: LVAD Dres Chg | Medical Action Industries, Inc. 306 |
| 2021-05-19 | Z-1558-2021 | Class I | Kit: Blood Culture | Medical Action Industries, Inc. 306 |
| 2021-05-19 | Z-1559-2021 | Class I | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical Action Industries, Inc. 306 |
| 2021-05-19 | Z-1560-2021 | Class II | Eyesuite 9 | Haag-Streit USA Inc |
| 2021-05-19 | Z-1561-2021 | Class II | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin | Remel Inc |
| 2021-05-19 | Z-1562-2021 | Class II | AFT Straight Tube | Musculoskeletal Transplant Foundation, Inc. |
| 2021-05-19 | Z-1563-2021 | Class II | Calibration Serum Level 3 | Randox Laboratories Ltd. |
| 2021-05-19 | Z-1564-2021 | Class III | VenaSeal Closure System | Medtronic Inc. |
| 2021-05-19 | Z-1565-2021 | Class II | REF CH3397 Oncology Kit w/Spiros¿ | ICU Medical, Inc. |
| 2021-05-19 | Z-1566-2021 | Class II | REF CH3582 5 IN | ICU Medical, Inc. |
| 2021-05-19 | Z-1567-2021 | Class II | REF 20124-01 30" | ICU Medical, Inc. |
| 2021-05-19 | Z-1568-2021 | Class II | REF 20130-01 Spinning Spiros Closed Male Luer | ICU Medical, Inc. |
| 2021-05-19 | Z-1569-2021 | Class II | REF Spinning Spiros Closed Male Luer | ICU Medical, Inc. |
| 2021-05-19 | Z-1570-2021 | Class II | REF CL3011 30" | ICU Medical, Inc. |
| 2021-05-19 | Z-1571-2021 | Class II | REF CL3028T 30" | ICU Medical, Inc. |
| 2021-05-19 | Z-1572-2021 | Class II | REF CL3538 Oncology Kit w/5" | ICU Medical, Inc. |
| 2021-05-19 | Z-1573-2021 | Class II | REF CL3946 Oncology Kit w/5" | ICU Medical, Inc. |
| 2021-05-19 | Z-1574-2021 | Class II | REF CL3960 Oncology Kit w/60" | ICU Medical, Inc. |
| 2021-05-19 | Z-1575-2021 | Class II | REF CL4151 45" | ICU Medical, Inc. |
| 2021-05-19 | Z-1576-2021 | Class II | REF CH2020 20mL Syringe w/Spinning Spiros | ICU Medical, Inc. |
| 2021-05-19 | Z-1577-2021 | Class II | REF CH2060 60mL Syringe w/Spinning Spiros | ICU Medical, Inc. |
| 2021-05-19 | Z-1578-2021 | Class II | REF CH3011 30" | ICU Medical, Inc. |
| 2021-05-19 | Z-1579-2021 | Class II | REF CH3020 40" | ICU Medical, Inc. |
| 2021-05-19 | Z-1580-2021 | Class II | REF CH3625 5" | ICU Medical, Inc. |
| 2021-05-19 | Z-1581-2021 | Class II | REF 011-CH3967 Admin Set w/ClaveTM | ICU Medical, Inc. |
| 2021-05-19 | Z-1582-2021 | Class II | REF 011-H2864-HSR 180 cm | ICU Medical, Inc. |
| 2021-05-19 | Z-1583-2021 | Class II | REF 011-H3597 42 cm | ICU Medical, Inc. |
| 2021-05-19 | Z-1584-2021 | Class II | REF 034-H2629 Appx 1 | ICU Medical, Inc. |
| 2021-05-19 | Z-1585-2021 | Class II | REF 20120-01 Spiros" Closed Male Luer | ICU Medical, Inc. |
| 2021-05-19 | Z-1586-2021 | Class II | REF 20130-01 Spinning Spiros¿ Closed Male Luer | ICU Medical, Inc. |
| 2021-05-19 | Z-1587-2021 | Class II | REF CH3034 5" | ICU Medical, Inc. |
| 2021-05-19 | Z-1588-2021 | Class II | REF CH3235 30" | ICU Medical, Inc. |
| 2021-05-19 | Z-1589-2021 | Class II | REF CH3762 35" | ICU Medical, Inc. |
| 2021-05-19 | Z-1590-2021 | Class II | REF K7040-001 Spinning Spiros Closed Male Luer | ICU Medical, Inc. |
| 2021-05-12 | Z-1519-2021 | Class II | Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless… | Oto Med Inc |
| 2021-05-12 | Z-1520-2021 | Class II | Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless… | Oto Med Inc |
| 2021-05-12 | Z-1521-2021 | Class II | Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2… | Oto Med Inc |
| 2021-05-12 | Z-1522-2021 | Class II | CareLink SmartSync Device Manager | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-12 | Z-1523-2021 | Class II | CRT-P Quad Models | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-12 | Z-1524-2021 | Class II | DJO EMPOWR KNEE Femoral Sizer | Encore Medical, LP |
| 2021-05-12 | Z-1525-2021 | Class II | Implantable Pulse Generators | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-12 | Z-1526-2021 | Class II | Implantable cardiac resynchronization therapy pacemakers | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-12 | Z-1527-2021 | Class II | Programmers | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-12 | Z-1528-2021 | Class II | CareLink SmartSync Device Manager | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2021-05-12 | Z-1529-2021 | Class II | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer… | LeMaitre Vascular, Inc. |
| 2021-05-12 | Z-1532-2021 | Class II | Medtronic Abre Venous Self-expanding Sent System | Medtronic Inc. |
| 2021-05-12 | Z-1533-2021 | Class II | Centricity Universal Viewer | GE Healthcare, LLC |
| 2021-05-12 | Z-1534-2021 | Class II | VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3 | Greiner Bio-One North America, Inc. |
| 2021-05-12 | Z-1535-2021 | Class II | Intellis Model 97755 Recharger | Medtronic Neuromodulation |
| 2021-05-05 | Z-1486-2021 | Class II | Protek Solo Venous Dilator Set: dilator | Cardiac Assist, Inc |
| 2021-05-05 | Z-1487-2021 | Class II | Spectrum IQ | Baxter Healthcare Corporation |
| 2021-05-05 | Z-1488-2021 | Class II | VERIGENE Processor SP | Luminex Corporation |
| 2021-05-05 | Z-1489-2021 | Class II | VITROS¿ Black Reference Slides CATALOG #: J02316 | Ortho-Clinical Diagnostics, INc. |
| 2021-05-05 | Z-1490-2021 | Class II | Colpassist Vaginal Positioning Device | Boston Scientific Corporation |
| 2021-05-05 | Z-1491-2021 | Class II | UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device | Boston Scientific Corporation |
| 2021-05-05 | Z-1492-2021 | Class III | EXALT Controller | Boston Scientific Corporation |
| 2021-05-05 | Z-1493-2021 | Class II | Chromosome X Alpha-Satellite in FITC Spectrum | Cytocell Ltd. |
| 2021-05-05 | Z-1494-2021 | Class II | Dental pins | Coltene Whaledent Inc |
| 2021-05-05 | Z-1495-2021 | Class II | Artis zee ceiling-interventional Fluoroscopic X-Ray System Model… | Siemens Medical Solutions USA, Inc |
| 2021-05-05 | Z-1496-2021 | Class II | Artis systems | Siemens Medical Solutions USA, Inc |
| 2021-05-05 | Z-1497-2021 | Class II | Interventional Fluoroscopic X-Ray System ARTIS icono biplane-… | Siemens Medical Solutions USA, Inc |
| 2021-05-05 | Z-1498-2021 | Class II | INFINITY_TRAY Custom Procedural Kit | ConMed Corporation |
| 2021-05-05 | Z-1499-2021 | Class II | KIT_INFINITY_BASE Custom Procedural Kit | ConMed Corporation |
| 2021-05-05 | Z-1500-2021 | Class II | InCore Lapidus Disposable Kit 28mm Left | Nextremity Solutions |
| 2021-05-05 | Z-1501-2021 | Class II | InCore Lapidus Disposable Kit 28mm Right | Nextremity Solutions |
| 2021-05-05 | Z-1502-2021 | Class II | Stryker Medela REF 077 | Medela AG Medical Technology |
| 2021-05-05 | Z-1503-2021 | Class II | Trinity Biotech Captia Measles IgM Kit | Clark Laboratories, Inc. |
| 2021-05-05 | Z-1504-2021 | Class II | Power Wheelchair | Merits Holdings Co. dba Merits Health Products, Inc. |
| 2021-05-05 | Z-1505-2021 | Class II | Scooter | Merits Holdings Co. dba Merits Health Products, Inc. |
| 2021-05-05 | Z-1506-2021 | Class III | Cardiosave Hybrid IABP | Datascope Corp. |
| 2021-05-05 | Z-1507-2021 | Class III | Cardiosave Rescue IABP | Datascope Corp. |
| 2021-05-05 | Z-1508-2021 | Class II | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY |
| 2021-05-05 | Z-1509-2021 | Class II | Filtered Triple-Leg Extension Set | B. Braun Medical, Inc. |
| 2021-05-05 | Z-1510-2021 | Class II | CANNU-Flex SILK Interference Screws 6 mmx 30 mm | Smith & Nephew, Inc. |
| 2021-05-05 | Z-1511-2021 | Class II | DONJOY REF:11-0447-9-ULTRASLING PRO | DJ Orthopedics de Mexico S.A. de C.V. |
| 2021-05-05 | Z-1512-2021 | Class II | DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15 | DJ Orthopedics de Mexico S.A. de C.V. |
| 2021-05-05 | Z-1513-2021 | Class II | DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30 | DJ Orthopedics de Mexico S.A. de C.V. |
| 2021-05-05 | Z-1514-2021 | Class II | DONJOY REF:11-0473-9 ULTRASLING PRO AB | DJ Orthopedics de Mexico S.A. de C.V. |
| 2021-05-05 | Z-1515-2021 | Class II | Palm Cups | Smiths Medical ASD Inc. |
| 2021-05-05 | Z-1516-2021 | Class II | ACE MDI Spacer with Small Mask | Smiths Medical ASD Inc. |
| 2021-05-05 | Z-1517-2021 | Class II | Philips Xper Flex Cardio | Philips North America Llc |
| 2021-05-05 | Z-1518-2021 | Class II | Omnia Soft Tissue Punch is a dental instrument designed to remove… | Omnia SRL |
| 2021-04-28 | Z-1375-2021 | Class I | Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel | Pacific Medical Group Inc. |
| 2021-04-28 | Z-1426-2021 | Class I | Instructions for Use and Patient Manual for HeartWare HVAD System | Heartware, Inc. |
| 2021-04-28 | Z-1431-2021 | Class II | Bard Clean-Cath Intermittent Catheter | C.R. Bard, Inc. |
| 2021-04-28 | Z-1432-2021 | Class II | Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label | AZURE BIOTECH INC |
| 2021-04-28 | Z-1433-2021 | Class II | The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled… | Boston Scientific Corporation |
| 2021-04-28 | Z-1434-2021 | Class II | Sensis/ Sensis Vibe Hemo systems with VD12A software as follows:… | Siemens Medical Solutions USA, Inc |
| 2021-04-28 | Z-1435-2021 | Class II | BCS XP System: Multipurpose system for in vitro coagulation studies | Siemens Healthcare Diagnostics, Inc. |
| 2021-04-28 | Z-1436-2021 | Class II | DirectInject consists of a sterile dual paste system which is calcium… | Stryker Leibinger GmbH & Co. KG |
| 2021-04-28 | Z-1437-2021 | Class II | Tritanium X TL Instruments | Stryker Spine |
| 2021-04-28 | Z-1438-2021 | Class II | Instructions for Use and Patient Manual for HeartWare HVAD System | Heartware, Inc. |
| 2021-04-28 | Z-1439-2021 | Class II | Endoskeleton TC Interbody System with Titan nanoLOCK Surface… | Medtronic Sofamor Danek USA, Inc |
| 2021-04-28 | Z-1440-2021 | Class II | Endoskeleton TC Interbody System with Titan nanoLOCK Surface… | Medtronic Sofamor Danek USA, Inc |
| 2021-04-28 | Z-1441-2021 | Class II | BIOTRONIK Ilestro 7 DR-T | BIOTRONIK Inc |
| 2021-04-28 | Z-1442-2021 | Class II | BIOTRONIK Ilestro 7 DR-T | BIOTRONIK Inc |
| 2021-04-28 | Z-1443-2021 | Class II | BIOTRONIK Ilestro 7 VR-T | BIOTRONIK Inc |
| 2021-04-28 | Z-1444-2021 | Class II | BIOTRONIK Ilestro 7 VR-T | BIOTRONIK Inc |
| 2021-04-28 | Z-1445-2021 | Class II | BIOTRONIK Ilestro 7 VR-T DX | BIOTRONIK Inc |
| 2021-04-28 | Z-1446-2021 | Class II | BIOTRONIK Iperia 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1447-2021 | Class II | BIOTRONIK Iforia 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1448-2021 | Class II | BIOTRONIK Iforia 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1449-2021 | Class II | BIOTRONIK IPERIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1450-2021 | Class II | BIOTRONIK ITREVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1451-2021 | Class II | BIOTRONIK ITREVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1452-2021 | Class II | BIOTRONIK ITREVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1453-2021 | Class II | BIOTRONIK IPERIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1454-2021 | Class II | BIOTRONIK INVENTRA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1455-2021 | Class II | BIOTRONIK ITREVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1456-2021 | Class II | BIOTRONIK ILIVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1457-2021 | Class II | BIOTRONIK ILIVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1458-2021 | Class II | BIOTRONIK ILIVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1459-2021 | Class II | BIOTRONIK INVENTRA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1460-2021 | Class II | BIOTRONIK INVENTRA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1461-2021 | Class II | BIOTRONIK ILIVIA 7 | BIOTRONIK Inc |
| 2021-04-28 | Z-1462-2021 | Class II | BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI | BIOTRONIK Inc |
| 2021-04-28 | Z-1463-2021 | Class II | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI | BIOTRONIK Inc |
| 2021-04-28 | Z-1464-2021 | Class II | BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI | BIOTRONIK Inc |
| 2021-04-28 | Z-1465-2021 | Class II | BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI | BIOTRONIK Inc |
| 2021-04-28 | Z-1466-2021 | Class II | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2021-04-28 | Z-1467-2021 | Class II | AngioDynamics Safe Sheath Ultralite | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2021-04-28 | Z-1468-2021 | Class II | Midline Catheter Dressing Change Kit with Statlock | Trinity Sterile, Inc. |
| 2021-04-28 | Z-1469-2021 | Class II | Instructions for Use and Patient Manual for HeartWare HVAD System | Heartware, Inc. |
| 2021-04-28 | Z-1470-2021 | Class II | LogiCal Monitoring Set | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1471-2021 | Class II | Mark 910 LogiCal | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1472-2021 | Class II | Left Heart Kit | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1473-2021 | Class II | LogiCal Left Heart Kit | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1474-2021 | Class II | Gang Cath Lab Set | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1475-2021 | Class II | ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1476-2021 | Class II | Manifold rotator | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1477-2021 | Class II | Stopcock rotator | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1478-2021 | Class II | HIGH PRESSURE TUBING | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1479-2021 | Class II | HIGH PRESSURE ROTATOR | Smiths Medical ASD Inc. |
| 2021-04-28 | Z-1480-2021 | Class II | Tubing with male luer lock adapter | Smiths Medical ASD Inc. |