| Reported | Recall | Class | Product | Firm |
|---|
| 2015-05-13 | Z-1584-2015 | Class II | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B | Siemens Medical Solutions USA, Inc. |
| 2015-05-13 | Z-1585-2015 | Class II | Aspire HD | Fujifilm Medical Systems U.S.A., Inc. |
| 2015-05-13 | Z-1586-2015 | Class II | BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x… | Bard Peripheral Vascular Inc |
| 2015-05-13 | Z-1587-2015 | Class III | Universal Charger Product Usage: The Stryker Universal Battery… | Stryker Instruments Div. of Stryker Corporation |
| 2015-05-13 | Z-1588-2015 | Class II | 119" | ICU Medical, Inc. |
| 2015-05-13 | Z-1589-2015 | Class II | 107" | ICU Medical, Inc. |
| 2015-05-13 | Z-1590-2015 | Class II | 104" | ICU Medical, Inc. |
| 2015-05-13 | Z-1591-2015 | Class II | 113" | ICU Medical, Inc. |
| 2015-05-13 | Z-1592-2015 | Class II | 108" | ICU Medical, Inc. |
| 2015-05-13 | Z-1593-2015 | Class II | 127" | ICU Medical, Inc. |
| 2015-05-13 | Z-1594-2015 | Class II | 98" | ICU Medical, Inc. |
| 2015-05-13 | Z-1595-2015 | Class II | 98" | ICU Medical, Inc. |
| 2015-05-06 | Z-1405-2015 | Class II | GE Healthcare Automatic Mobile X-Ray | GE Healthcare |
| 2015-05-06 | Z-1406-2015 | Class II | GE Healthcare Automatic Mobile X-Ray | GE Healthcare |
| 2015-05-06 | Z-1407-2015 | Class II | GE Healthcare Automatic Mobile X-Ray | GE Healthcare |
| 2015-05-06 | Z-1519-2015 | Class II | Light Sheer Desire Diode Laser System with XC Handpiece Accessory… | Lumenis Limited |
| 2015-05-06 | Z-1520-2015 | Class II | AmTryke Model 1424 Community Cruiser Hand Cycle | Amtryke LLC |
| 2015-05-06 | Z-1521-2015 | Class II | Software Version 2 | Ortho-Clinical Diagnostics |
| 2015-05-06 | Z-1522-2015 | Class II | MicroScan -Neg Breakpoint Combo Panel Type 34 | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1523-2015 | Class II | Anatomical Shoulder Handle for Rasp Item: 01 | Zimmer Gmbh |
| 2015-05-06 | Z-1524-2015 | Class II | MicroScan Pos Combo Panel Type 33 | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1525-2015 | Class II | WEBSTER HIS Catheter | Biosense Webster, Inc. |
| 2015-05-06 | Z-1526-2015 | Class II | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse… | Cyberonics, Inc |
| 2015-05-06 | Z-1527-2015 | Class II | 9F Plastic Dual Port | Medical Components, Inc dba MedComp |
| 2015-05-06 | Z-1528-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1529-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1530-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1531-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1532-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1533-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1534-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels… | Beckman Coulter, Inc. |
| 2015-05-06 | Z-1535-2015 | Class II | CD99 Catalog number PM008 AA | Biocare Medical, LLC |
| 2015-05-06 | Z-1536-2015 | Class II | The Patient Control Module | Baxter Healthcare Corp. |
| 2015-05-06 | Z-1537-2015 | Class II | Logicon Caries Detector Product Usage: Analyze inter-proximal tooth… | GA Industries |
| 2015-05-06 | Z-1538-2015 | Class II | Genesis Malleable Penile Prosthesis | Coloplast Manufacturing US, LLC |
| 2015-05-06 | Z-1539-2015 | Class II | FAR-Infrared Heat Home Sauna | Therasage, LLC. |
| 2015-05-06 | Z-1540-2015 | Class II | FAR-Infrared Heat Home Sauna | Therasage, LLC. |
| 2015-05-06 | Z-1541-2015 | Class II | Portable FAR Infrared Sauna Indications including | Therasage, LLC. |
| 2015-05-06 | Z-1542-2015 | Class II | Ultraview SL Command Modules | Spacelabs Healthcare Inc |
| 2015-05-06 | Z-1543-2015 | Class II | Remote Network Station | Nihon Kohden America Inc |
| 2015-05-06 | Z-1544-2015 | Class II | Integra Long Epidural Steroid Injection Needle | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| 2015-05-06 | Z-1545-2015 | Class II | Insorb Subcuticular Skin Stapler | Incisive Surgical Inc |
| 2015-05-06 | Z-1546-2015 | Class II | Female Driver | Pega Medical Inc. |
| 2015-05-06 | Z-1547-2015 | Class II | 4 | Alphatec Spine, Inc. |
| 2015-05-06 | Z-1548-2015 | Class II | Test Request Distributor | Dako North America Inc. |
| 2015-05-06 | Z-1549-2015 | Class II | 2008 Series Hemodialysis Machines: 2008Kathome | Fresenius Medical Care Holdings, Inc. |
| 2015-05-06 | Z-1550-2015 | Class II | 2008 Series Hemodialysis Machines: 2008T with the following product… | Fresenius Medical Care Holdings, Inc. |
| 2015-05-06 | Z-1551-2015 | Class II | 2008 Series Hemodialysis Machines: 2008K with the following product… | Fresenius Medical Care Holdings, Inc. |
| 2015-05-06 | Z-1552-2015 | Class II | 2008 Series Hemodialysis Machines: 2008K2 with the following product… | Fresenius Medical Care Holdings, Inc. |
| 2015-05-06 | Z-1553-2015 | Class II | Synthes Small Battery Drive | The Anspach Effort, Inc. |
| 2015-05-06 | Z-1556-2015 | Class II | CareFusion Vital Signs LightWand Stylet | Vital Signs Colorado Inc. |
| 2015-05-06 | Z-1557-2015 | Class II | Introduction Pack | Vital Signs Colorado Inc. |
| 2015-05-06 | Z-1558-2015 | Class II | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier | Teleflex Medical |
| 2015-05-06 | Z-1559-2015 | Class II | Caviwave Pro Ultrasonic Cleaning System | Steris Corporation |
| 2015-05-06 | Z-1560-2015 | Class II | PowerLoc MAX Safety Winged Infusion Set | Bard Access Systems |
| 2015-05-06 | Z-1561-2015 | Class II | AMSCO C and AMSCO 400 Steam Sterilizers | Steris Corporation |
| 2015-04-29 | Z-1454-2015 | Class II | STRATIFY JCV DxSelect | Focus Diagnostics Inc |
| 2015-04-29 | Z-1455-2015 | Class II | DBX Mix | Musculoskeletal Transplant Foundation, Inc. |
| 2015-04-29 | Z-1456-2015 | Class I | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE… | OriGen Biomedical, Inc. |
| 2015-04-29 | Z-1457-2015 | Class II | ADVIA Chemistry Lipase Reagent | Siemens Healthcare Diagnostics, Inc. |
| 2015-04-29 | Z-1458-2015 | Class II | Spacelabs Pediatric Flow Sensor Kit | Del Mar Reynolds Medical, Ltd. |
| 2015-04-29 | Z-1459-2015 | Class II | Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44 | Exactech, Inc. |
| 2015-04-29 | Z-1461-2015 | Class I | TIGERPAW System II | Laax, Inc. |
| 2015-04-29 | Z-1462-2015 | Class I | TIGERPAW System II | Laax, Inc. |
| 2015-04-29 | Z-1463-2015 | Class II | Fluid Management System P4000 | Thermedx LLC |
| 2015-04-29 | Z-1464-2015 | Class II | DiaSorin | Diasorin Inc. |
| 2015-04-29 | Z-1465-2015 | Class II | Lineum HF Torque Handle Limit | Biomet Spine, LLC |
| 2015-04-29 | Z-1466-2015 | Class II | Torque Limiting Handle | Biomet Spine, LLC |
| 2015-04-29 | Z-1467-2015 | Class II | 6" Trifurcated Extension Set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1468-2015 | Class II | Bifircated Extension Set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1469-2015 | Class II | 4" Microbore Double Lumen Set with Bionector | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1470-2015 | Class II | 4" Microbore Trifurcated Ext set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1471-2015 | Class II | 4" Microbore T-Port Set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1472-2015 | Class II | 8" Standard Bore Ext Set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1473-2015 | Class II | 7" High Pressure Set with Bionector | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1474-2015 | Class II | 7" Standard Bore High Pressure Ext Set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1475-2015 | Class II | 7" Standard Bore High Pressure Ext Set | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1476-2015 | Class II | Bifurcated set with check vales and Bionectors | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1477-2015 | Class II | 4" Trifurcated set with Bionectors and check valves | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1478-2015 | Class II | 6" Trifurcated set with Bionectors | Churchill Medical Systems, Inc. |
| 2015-04-29 | Z-1479-2015 | Class II | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical… | SpineFrontier, Inc. |
| 2015-04-29 | Z-1480-2015 | Class II | Captiva's lumbar intervertebral fusion system Reamers | Captiva Spine, Inc |
| 2015-04-29 | Z-1481-2015 | Class II | HSG Trays/HS 5F Catheter Combo | Catheter Research, Inc |
| 2015-04-29 | Z-1482-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1483-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1484-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1485-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1486-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1487-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1488-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1489-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1490-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1491-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1492-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1493-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1494-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1495-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1496-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1497-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1498-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1499-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1500-2015 | Class II | CROSSCHECK | Wright Medical Technology, Inc. |
| 2015-04-29 | Z-1501-2015 | Class II | Sentec | SenTec AG |
| 2015-04-29 | Z-1502-2015 | Class II | Herbst Universal Nut which is used in a Herbst Appliance A Herbst… | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1503-2015 | Class II | MiniScope Hst ROC Crown 15 Patient Kit | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1504-2015 | Class II | TS Herbst Nuts with Backing | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1505-2015 | Class II | Specialty MiniScope Mech | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1506-2015 | Class II | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst… | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1507-2015 | Class II | HTM Mechanism Set Set 16 | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1508-2015 | Class II | LR Telescoping Cantilever Arms | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1509-2015 | Class II | TS Crown Component 4UR | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1510-2015 | Class II | Upper Right Telescope Unibodies | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1511-2015 | Class II | TS ROC Crown Component 4UR | Specialty Appliance Works, Inc. |
| 2015-04-29 | Z-1512-2015 | Class II | Xpress System Pedicle Screw Assembly | X Spine Systems Inc |
| 2015-04-29 | Z-1513-2015 | Class II | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical… | CSA Medical |
| 2015-04-29 | Z-1514-2015 | Class II | Sony Medical Monitor LMD-1951MD 19 inch | Sony Latin America |
| 2015-04-29 | Z-1515-2015 | Class II | OptiMedica Catalys Precision Laser System | Abbott Medical Optics, Inc. |
| 2015-04-29 | Z-1516-2015 | Class II | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a… | PhotoMedex, Inc. |
| 2015-04-29 | Z-1517-2015 | Class II | The PCA 3 infusion pump allows clinicians | Hospira Inc. |
| 2015-04-29 | Z-1518-2015 | Class II | The LifeCare PCA infusion system with Hospira MedNet software allows… | Hospira Inc. |
| 2015-04-22 | Z-1409-2015 | Class II | 3i T3 Non-Platform Switched Tapered Implant Rx Only | Biomet 3i, LLC |
| 2015-04-22 | Z-1410-2015 | Class II | OSSEOTITE Tapered Certain Implant Rx Only | Biomet 3i, LLC |
| 2015-04-22 | Z-1411-2015 | Class II | OSSEOTITE Certain 2 Implant Rx only | Biomet 3i, LLC |
| 2015-04-22 | Z-1412-2015 | Class II | Natus neoBLUE blanket LED Phototherapy system which includes the… | Natus Medical Incorporated |
| 2015-04-22 | Z-1413-2015 | Class II | Bard ConQuest PTA Balloon Dilatation Catheter | Bard Peripheral Vascular Inc |
| 2015-04-22 | Z-1414-2015 | Class II | Replace Select Tapered TiU NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1415-2015 | Class II | Replace Select Tapered TiU NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1416-2015 | Class II | Replace Select Tapered TiU NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1417-2015 | Class II | Replace Select Tapered TiU WP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1418-2015 | Class II | Replace Select Tapered TiU WP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1419-2015 | Class II | NOBELREPLACE Tapered Groovy RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1420-2015 | Class II | NOBELREPLACE Tapered Groovy RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1421-2015 | Class II | NOBELREPLACE Tapered Groovy 6 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1422-2015 | Class II | NobRpl Tapered Groovy 6 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1423-2015 | Class II | Replace Select Tapered TiU NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1424-2015 | Class II | Replace Select Tapered TiU RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1425-2015 | Class II | NobelReplace CC NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1426-2015 | Class II | NobelReplace CC NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1427-2015 | Class II | NobelReplace CC NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1428-2015 | Class II | NobelReplace CC RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1429-2015 | Class II | NobelReplace CC RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1430-2015 | Class II | NobelReplace CC RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1431-2015 | Class II | NobelReplace CC RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1432-2015 | Class II | NobelReplace CC RP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1433-2015 | Class II | NobelReplace CC RP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1434-2015 | Class II | NobelReplace CC RP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1435-2015 | Class II | NobelReplace CC PMC NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1436-2015 | Class II | NobelReplace CC PMC NP 3 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1437-2015 | Class II | NobelReplace CC PMC RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1438-2015 | Class II | NobelReplace CC PMC RP 4 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1439-2015 | Class II | NobelReplace CC PMC RP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1440-2015 | Class II | NobelReplace CC PMC RP 5 | Nobel Biocare Usa Llc |
| 2015-04-22 | Z-1441-2015 | Class II | Kenex Radiation Shield installed with GE Healthcare Interventional | GE Healthcare |
| 2015-04-22 | Z-1442-2015 | Class II | ProTrack Microcatheter | Baylis Medical Corp * |
| 2015-04-22 | Z-1443-2015 | Class II | Bard Peripherally Inserted Central Catheter | Bard Access Systems |
| 2015-04-22 | Z-1444-2015 | Class II | Hardy Diagnostics cat no | Hardy Diagnostics |
| 2015-04-22 | Z-1445-2015 | Class II | Artis Q/ Q zen systems | Siemens Medical Solutions USA, Inc |
| 2015-04-22 | Z-1446-2015 | Class II | LOW PROFILE NON-LOCK SCREW | Biomet, Inc. |
| 2015-04-22 | Z-1447-2015 | Class II | Bard Monopty Disposable Core Biopsy Instruments and Kits | Bard Peripheral Vascular Inc |
| 2015-04-22 | Z-1448-2015 | Class II | SpermMar Test 0 | Vitrolife Inc |
| 2015-04-22 | Z-1449-2015 | Class II | Magellan Robotic System | Hansen Medical Inc |
| 2015-04-22 | Z-1450-2015 | Class II | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical | CooperSurgical, Inc. |
| 2015-04-22 | Z-1451-2015 | Class II | Master Drug Library Software version 8 | Baxter Healthcare Corp |
| 2015-04-22 | Z-1452-2015 | Class II | Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use | Integra LifeSciences Corp. |
| 2015-04-22 | Z-1453-2015 | Class II | Talon Grasping Device | US Endoscopy Group Inc |
| 2015-04-15 | Z-1328-2015 | Class I | Ebola IgX VP-40 Serum/Plasma/Blood Cassette | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1329-2015 | Class I | Ebola GP IgX Blood | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1330-2015 | Class I | Ebola VP-40 IgG/IgM | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1331-2015 | Class I | Ebola GP IgM Blood | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1332-2015 | Class I | Ebola Accessories assembled | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1333-2015 | Class I | Ebola Virus Antigen Nasal | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1334-2015 | Class I | Ebola Virus Antigen Blood | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1335-2015 | Class I | Ebola Virus GP-VP IgS | Lusys Laboratories, Inc. |
| 2015-04-15 | Z-1377-2015 | Class II | CS 8100 | Carestream Health, Inc. |
| 2015-04-15 | Z-1378-2015 | Class II | CS 8100 3D | Carestream Health, Inc. |
| 2015-04-15 | Z-1379-2015 | Class II | ROTROL P Control for ROTEM delta Thromboelastometry System | TEM Systems Inc |
| 2015-04-15 | Z-1380-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1381-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1382-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1383-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1384-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1385-2015 | Class II | da Vinci Si Surgical System IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1386-2015 | Class II | da Vinci Si Surgical System IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1387-2015 | Class II | da Vinci S / Si Surgical System IS2000 / IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1388-2015 | Class II | da Vinci S / Si Surgical System IS2000 / IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1389-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1390-2015 | Class II | da Vinci S Surgical System IS2000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1391-2015 | Class II | da Vinci Si Surgical System IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1392-2015 | Class II | da Vinci Si Surgical System IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1393-2015 | Class II | da Vinci Si Surgical System IS3000 | Intuitive Surgical, Inc. |
| 2015-04-15 | Z-1394-2015 | Class II | INFX-8000V Interventional Angiography System | Toshiba American Medical Systems Inc |
| 2015-04-15 | Z-1396-2015 | Class II | Instrument Kit for use with OsteoSponge SC grafts | Bacterin International, Inc. |
| 2015-04-15 | Z-1397-2015 | Class II | CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N… | CooperSurgical, Inc. |
| 2015-04-15 | Z-1398-2015 | Class II | QuikLYTE Dilution Check: used to monitor and adjust for the dilution… | Siemens Healthcare Diagnostics, Inc. |
| 2015-04-15 | Z-1399-2015 | Class II | ADVIA Chemistry XPT System | Siemens Healthcare Diagnostics, Inc. |
| 2015-04-15 | Z-1400-2015 | Class II | CIVCO Surgi-Tip Transducer Cover Sterile | Civco Medical Instruments Inc |
| 2015-04-15 | Z-1401-2015 | Class III | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card | Biomerieux Inc |
| 2015-04-15 | Z-1402-2015 | Class III | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card | Biomerieux Inc |
| 2015-04-15 | Z-1403-2015 | Class III | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card | Biomerieux Inc |
| 2015-04-15 | Z-1404-2015 | Class II | Pluer-evac Sahara Chest Drainage System | Teleflex Medical |