| Reported | Recall | Class | Product | Firm |
|---|
| 2015-03-04 | Z-1164-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1165-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1166-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1167-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1168-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1169-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1170-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1171-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1172-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1173-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1174-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1175-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1176-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1177-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1178-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1179-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1180-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1181-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1182-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1183-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1184-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1185-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1186-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1187-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1188-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1189-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1190-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1191-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1192-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1193-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1194-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1195-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1196-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1197-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1198-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1199-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1200-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1201-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1202-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1203-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1204-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1205-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1206-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1207-2015 | Class II | NAMIC Convenience Kit | Navilyst Medical, Inc |
| 2015-03-04 | Z-1208-2015 | Class II | Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with… | Biomet, Inc. |
| 2015-03-04 | Z-1212-2015 | Class II | COMPASS SW Version 3 | Iba Dosimetry Gmbh |
| 2015-03-04 | Z-1213-2015 | Class II | Manual Toothbrush | Norwex Usa Inc |
| 2015-03-04 | Z-1214-2015 | Class II | The Centricity PACS Workstation is intended for use as a primary… | GE Healthcare |
| 2015-03-04 | Z-1215-2015 | Class II | The Brainlab Offset Cup Impactor Universal | Brainlab AG |
| 2015-02-25 | Z-1035-2015 | Class I | This correction applies to all GE Healthcare MRI systems with… | GE Healthcare |
| 2015-02-25 | Z-1061-2015 | Class I | Echostar Spica 1 | Alltech Medical Systems America Inc |
| 2015-02-25 | Z-1116-2015 | Class II | Terumo HX2 Temperature Management System provides temperature control… | Terumo Cardiovascular Systems Corporation |
| 2015-02-25 | Z-1117-2015 | Class II | HARMONIC ACE Curved Shears Instructions for Use | Intuitive Surgical, Inc. |
| 2015-02-25 | Z-1118-2015 | Class II | HARMONIC ACE Curved Shears Instructions for Use | Intuitive Surgical, Inc. |
| 2015-02-25 | Z-1119-2015 | Class II | Artis One | Siemens Medical Solutions USA, Inc |
| 2015-02-25 | Z-1121-2015 | Class II | Pulsiocath PiCCO ProAQT Monitoring Kit | Pulsion Medical Inc |
| 2015-02-25 | Z-1122-2015 | Class II | Mallory Head 4 Finned Acetabular Shell 50 mm | Biomet, Inc. |
| 2015-02-25 | Z-1123-2015 | Class II | Ringloc+ Acetabular Shell Finned 52 mm | Biomet, Inc. |
| 2015-02-25 | Z-1124-2015 | Class II | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced… | Teleflex, Inc. |
| 2015-02-25 | Z-1125-2015 | Class III | Alive ECG App 2 | Alivecor SFO |
| 2015-02-25 | Z-1126-2015 | Class II | BodyGuard 323 pump | CME America, LLC |
| 2015-02-25 | Z-1127-2015 | Class II | MC-500 Multicolor Laser Photocoagulator | Nidek Inc |
| 2015-02-25 | Z-1128-2015 | Class II | Restoris Partial Knee Application | Mako Surgical Corporation |
| 2015-02-25 | Z-1129-2015 | Class II | Cold Therapy Pad | Cincinnati Sub-Zero Products Inc |
| 2015-02-25 | Z-1130-2015 | Class II | Haemonetics TEG Hemostasis System Level II Control | Haemonetics Corporation |
| 2015-02-18 | Z-1008-2015 | Class I | MAQUET Servo Humidifier 163 | Teleflex, Inc. |
| 2015-02-18 | Z-1051-2015 | Class I | MAQUET | Teleflex Medical |
| 2015-02-18 | Z-1062-2015 | Class II | CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon… | Maquet Datascope Corp - Cardiac Assist Division |
| 2015-02-18 | Z-1063-2015 | Class II | ACUSON S2000 Automated Breast Volume Scanner | Siemens Medical Solutions USA, Inc. |
| 2015-02-18 | Z-1064-2015 | Class II | Digital Mobile X-ray Systems used to take diagnostic radiographic… | Virtual Imaging, Inc. |
| 2015-02-18 | Z-1065-2015 | Class II | SoftPath Laboratory Information System | SCC Soft Computer |
| 2015-02-18 | Z-1066-2015 | Class II | System 6 Aseptic Housing | Stryker Instruments Div. of Stryker Corporation |
| 2015-02-18 | Z-1067-2015 | Class II | EPWorks software used in the Protektor 32 Product Usage: Uses… | Natus Medical Incorporated |
| 2015-02-18 | Z-1068-2015 | Class II | EPWorks software used in the Xltek Protektor Stimulator Product… | Natus Medical Incorporated |
| 2015-02-18 | Z-1069-2015 | Class II | Timberline Cranial Caudal and Posterior Blades | Biomet Spine, LLC |
| 2015-02-18 | Z-1070-2015 | Class II | Aquarius iNtuition Client Viewer | TeraRecon, Inc. |
| 2015-02-18 | Z-1076-2015 | Class II | The SurgiWrap Bioresorbable Adhesion Barrier Film | MAST Biosurgery USA, Inc |
| 2015-02-18 | Z-1077-2015 | Class III | Flyte Togas are components of the Stryker Flyte System and are… | Stryker Instruments Div. of Stryker Corporation |
| 2015-02-18 | Z-1078-2015 | Class II | Hudson RCI | Teleflex Medical |
| 2015-02-18 | Z-1080-2015 | Class II | ARROW Epidural Needle Component | Arrow International Inc |
| 2015-02-18 | Z-1081-2015 | Class III | VisiPlugST for the Lacrimal Efficiency Test | Lacrimedics Inc |
| 2015-02-18 | Z-1082-2015 | Class II | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit | Arrow International Inc |
| 2015-02-18 | Z-1083-2015 | Class II | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P | Medical Components, Inc dba MedComp |
| 2015-02-18 | Z-1084-2015 | Class II | The MAYFIELD¿ Ultra 360 Base Unit for head positioner | Integra LifeSciences Corporation |
| 2015-02-18 | Z-1085-2015 | Class II | LMA | Teleflex Medical |
| 2015-02-18 | Z-1086-2015 | Class II | The Siemens Symbia S series is intended to aid in detecting | Siemens Medical Solutions USA, Inc. |
| 2015-02-18 | Z-1087-2015 | Class II | The Siemens Symbia T series is intended to aid in detecting | Siemens Medical Solutions USA, Inc. |
| 2015-02-18 | Z-1088-2015 | Class II | Precise Digital Accelerator Intended to be used for radiation therapy… | Elekta, Inc. |
| 2015-02-18 | Z-1089-2015 | Class II | Telluride Percutaneous Rod Inserter Long | Biomet Spine, LLC |
| 2015-02-18 | Z-1090-2015 | Class II | MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm | Stryker Craniomaxillofacial Division |
| 2015-02-18 | Z-1091-2015 | Class II | MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR… | Stryker Craniomaxillofacial Division |
| 2015-02-18 | Z-1092-2015 | Class II | MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in… | Stryker Craniomaxillofacial Division |
| 2015-02-18 | Z-1093-2015 | Class II | MEDPOR TITAN MAX Orbital Floor and Wall | Stryker Craniomaxillofacial Division |
| 2015-02-18 | Z-1094-2015 | Class II | Hemostatic Bone Putty | Synthes, Inc. |
| 2015-02-18 | Z-1095-2015 | Class II | Hudson RCI¿ Humidifier Adaptor | Teleflex Medical |
| 2015-02-18 | Z-1096-2015 | Class II | AQUAPAK 101 SW | Teleflex Medical |
| 2015-02-18 | Z-1097-2015 | Class II | AQUAPAK 340 SW | Teleflex Medical |
| 2015-02-18 | Z-1098-2015 | Class II | AQUAPAK 340 SW | Teleflex Medical |
| 2015-02-18 | Z-1099-2015 | Class II | AQUAPAK SW/EAU STERILE | Teleflex Medical |
| 2015-02-18 | Z-1100-2015 | Class II | AQUAPAK 340 SW | Teleflex Medical |
| 2015-02-18 | Z-1101-2015 | Class II | AQUAPAK 340 SW | Teleflex Medical |
| 2015-02-18 | Z-1102-2015 | Class II | AQUA 540 SW | Teleflex Medical |
| 2015-02-18 | Z-1103-2015 | Class II | AQUAPAK 640 SW | Teleflex Medical |
| 2015-02-18 | Z-1104-2015 | Class II | AQUAPAK SW/EAU STERILE | Teleflex Medical |
| 2015-02-18 | Z-1105-2015 | Class II | AQUAPAK 640 SW | Teleflex Medical |
| 2015-02-18 | Z-1106-2015 | Class II | AQUAPAK 640 SW | Teleflex Medical |
| 2015-02-18 | Z-1107-2015 | Class II | ADAPTOR | Teleflex Medical |
| 2015-02-18 | Z-1108-2015 | Class II | AQUAPAK 340 SW | Teleflex Medical |
| 2015-02-18 | Z-1109-2015 | Class II | AQUAPAK 640 SW | Teleflex Medical |
| 2015-02-18 | Z-1110-2015 | Class II | Arthrosurface 25&30mm 10 | Arthrosurface, Inc. |
| 2015-02-18 | Z-1111-2015 | Class II | Arthrosurface 25&30mm 12 | Arthrosurface, Inc. |
| 2015-02-18 | Z-1112-2015 | Class II | Arthrosurface 35mm 13 | Arthrosurface, Inc. |
| 2015-02-18 | Z-1113-2015 | Class II | Athrosurface 40mm 13 | Arthrosurface, Inc. |
| 2015-02-18 | Z-1114-2015 | Class II | Arthrosurface HHXL | Arthrosurface, Inc. |
| 2015-02-18 | Z-1115-2015 | Class II | GemLock Long Hex Driver | Zimmer Dental Inc |
| 2015-02-11 | Z-1017-2015 | Class I | Covidien Trellis-6 Peripheral Infusion System | Covidien |
| 2015-02-11 | Z-1018-2015 | Class I | Covidien Trellis-8 Peripheral Infusion System | Covidien |
| 2015-02-11 | Z-1033-2015 | Class II | DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE | Express Diagnostics Int'l., Inc. |
| 2015-02-11 | Z-1034-2015 | Class II | Animas Vibe Insulin Infusion Pump | Animas Corporation |
| 2015-02-11 | Z-1036-2015 | Class II | G- Series Beds | Invacare Corporation |
| 2015-02-11 | Z-1037-2015 | Class II | 16cm Minimally Invasive Attachment | The Anspach Effort, Inc. |
| 2015-02-11 | Z-1038-2015 | Class II | SoftLab with SA HIS versions 4 | SCC Soft Computer |
| 2015-02-11 | Z-1039-2015 | Class II | Baxter Integrated APD Set with Cassette 3-Prong | Baxter Healthcare Corp. |
| 2015-02-11 | Z-1040-2015 | Class II | MobileDiagnost wDR motorized portable diagnostic X-ray systems | Sedecal S.A. |
| 2015-02-11 | Z-1041-2015 | Class II | Cobas b 221 | Roche Diagnostics Operations, Inc. |
| 2015-02-11 | Z-1042-2015 | Class II | Zimmer PERSONA Tibial Articular Surface Inserter | Zimmer, Inc. |
| 2015-02-11 | Z-1043-2015 | Class II | Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref… | Stryker Howmedica Osteonics Corp. |
| 2015-02-11 | Z-1046-2015 | Class II | ABL90 FLEX analyzer | Radiometer America Inc |
| 2015-02-11 | Z-1047-2015 | Class II | Fresenius Crit Line in a Clip | Fresenius Medical Care Holdings, Inc. |
| 2015-02-11 | Z-1048-2015 | Class II | da Vinci Si Surgical System | Intuitive Surgical, Inc. |
| 2015-02-11 | Z-1049-2015 | Class II | FORUM Archive and Viewer | Carl Zeiss Meditec AG |
| 2015-02-11 | Z-1050-2015 | Class II | Plum A+ Infusion System with Hospira MedNet List 20792-04-25 | Hospira Inc. |
| 2015-02-11 | Z-1052-2015 | Class II | Persona | Zimmer, Inc. |
| 2015-02-11 | Z-1053-2015 | Class II | SmartSite Low Sorbing Infusion Set | CareFusion 303, Inc. |
| 2015-02-11 | Z-1054-2015 | Class II | Lubricated Intubating Stylet 6FR that is inserted into an… | Cardinal Health |
| 2015-02-11 | Z-1055-2015 | Class II | BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula | Becton Dickinson & Company |
| 2015-02-11 | Z-1056-2015 | Class II | ACUSON SC2000 Ultrasound System | Siemens Medical Solutions USA, Inc. |
| 2015-02-11 | Z-1057-2015 | Class II | KYPHON EXPRESS | Medtronic Sofamor Danek USA Inc |
| 2015-02-11 | Z-1058-2015 | Class II | Puritan Bennett 980 Ventilator System | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| 2015-02-11 | Z-1059-2015 | Class II | LINAC Accelerators: ARTISTE | Siemens Medical Solutions USA, Inc |
| 2015-02-11 | Z-1060-2015 | Class II | Shape-HF Cardiopulmonary Testing System Disposable Patient Interface | Shape Medical Systems, Inc |
| 2015-02-04 | Z-0955-2015 | Class II | The Revolution CT is a multi-slice | GE Healthcare |
| 2015-02-04 | Z-1009-2015 | Class II | The Synthes Mandible External Fixator | Synthes, Inc. |
| 2015-02-04 | Z-1010-2015 | Class II | Product Code 2C4013 | Baxter Healthcare Corp. |
| 2015-02-04 | Z-1011-2015 | Class II | BrightView model number: 882478 BrightView X model number: 882480… | Philips Medical Systems (Cleveland) Inc |
| 2015-02-04 | Z-1012-2015 | Class II | Miethke Shunt System accessories Product Usage: | Aesculap, Inc. |
| 2015-02-04 | Z-1013-2015 | Class II | Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE | Siemens Medical Solutions USA, Inc |
| 2015-02-04 | Z-1014-2015 | Class II | Ebb Complete Tamponade System | Clinical Innovations, LLC |
| 2015-02-04 | Z-1015-2015 | Class II | ASSY | Fresenius Medical Care Holdings, Inc. |
| 2015-02-04 | Z-1016-2015 | Class II | Airo Mobile Intraoperative CT I Airo | Mobius Imaging, LLC |
| 2015-02-04 | Z-1019-2015 | Class II | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1 | Sunrise Medical (US) LLC |
| 2015-02-04 | Z-1020-2015 | Class II | Quickie Q7 Adult Rigid Wheelchair Model EIR4 | Sunrise Medical (US) LLC |
| 2015-02-04 | Z-1021-2015 | Class II | 2 | Synthes, Inc. |
| 2015-02-04 | Z-1022-2015 | Class II | VC150 Vital Signs Monitor | INNOKAS MEDICAL OY |
| 2015-02-04 | Z-1023-2015 | Class II | Beckman Coulter | Beckman Coulter Inc. |
| 2015-02-04 | Z-1024-2015 | Class II | Beckman Coulter | Beckman Coulter Inc. |
| 2015-02-04 | Z-1025-2015 | Class II | Beckman Coulter | Beckman Coulter Inc. |
| 2015-02-04 | Z-1026-2015 | Class II | Beckman Coulter | Beckman Coulter Inc. |
| 2015-02-04 | Z-1027-2015 | Class II | Syngo | Siemens Medical Solutions USA, Inc |
| 2015-02-04 | Z-1028-2015 | Class III | Portex Anaerobic Pulsator Arterial Blood Sampling Kit | Smiths Medical ASD, Inc. |
| 2015-02-04 | Z-1029-2015 | Class II | Verasense Knee System | Orthosensor, Inc. |
| 2015-02-04 | Z-1030-2015 | Class III | Arrow Select Kits | Arrow International Inc |
| 2015-02-04 | Z-1031-2015 | Class II | HomeChoice/HomeChoice Pro Automated Personal Cycler | Baxter Healthcare Corp. |
| 2015-02-04 | Z-1032-2015 | Class II | HEPFLUSH-10 | Fresenius Kabi USA, LLC |
| 2015-01-28 | Z-0993-2015 | Class II | TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet… | Maquet Medical Systems USA |
| 2015-01-28 | Z-0994-2015 | Class II | Ysio Max | Siemens Medical Solutions USA, Inc |
| 2015-01-28 | Z-0995-2015 | Class II | Ferno Model 35X PROFlexx Stretchers | Ferno-Washington Inc |
| 2015-01-28 | Z-0996-2015 | Class II | Powered stretcher chair used during facial and eye surgeries | TransMotion Medical Inc |
| 2015-01-28 | Z-0997-2015 | Class II | Philips IntelliVue TcG10 | Philips Medical Systems, Inc. |
| 2015-01-28 | Z-0998-2015 | Class II | Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate… | Cordis Corporation |
| 2015-01-28 | Z-0999-2015 | Class III | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test | Roche Molecular Systems, Inc. |
| 2015-01-28 | Z-1000-2015 | Class II | CD8 | BD Biosciences, Systems & Reagents |
| 2015-01-28 | Z-1001-2015 | Class II | PF4 Concentrated Wash | Genetic Testing Institute,inc |
| 2015-01-28 | Z-1002-2015 | Class II | Anti-Lambda APC-H7 | BD Biosciences, Systems & Reagents |
| 2015-01-28 | Z-1003-2015 | Class II | Fitness Gear Inversion table | Dick's Sporting Goods |
| 2015-01-28 | Z-1004-2015 | Class III | VITROS Software Version 3 | Ortho-Clinical Diagnostics |
| 2015-01-28 | Z-1005-2015 | Class II | Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code:… | Arrow International Inc |
| 2015-01-28 | Z-1006-2015 | Class II | FLUTTER Percussor respiratory device | Aptalis Pharmatech Inc. |
| 2015-01-28 | Z-1007-2015 | Class II | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and… | Arrow International Inc |
| 2015-01-21 | Z-0840-2015 | Class II | GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general… | GE OEC Medical Systems, Inc |
| 2015-01-21 | Z-0841-2015 | Class II | GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general… | GE OEC Medical Systems, Inc |
| 2015-01-21 | Z-0854-2015 | Class II | Artis zee/ zeego systems | Siemens Medical Solutions USA, Inc |
| 2015-01-21 | Z-0915-2015 | Class I | Lotus TAVR 23mm | Boston Scientific Corporation |
| 2015-01-21 | Z-0916-2015 | Class I | Lotus TAVR 25mm | Boston Scientific Corporation |
| 2015-01-21 | Z-0917-2015 | Class I | Lotus TAVR 27mm | Boston Scientific Corporation |
| 2015-01-21 | Z-0947-2015 | Class II | Phadia 1000 Instrument | Phadia US Inc |
| 2015-01-21 | Z-0948-2015 | Class II | The Abbott m2000sp is an automated system for performing sample… | Abbott Molecular |
| 2015-01-21 | Z-0949-2015 | Class II | Merlin@home RF Remote Monitoring Transmitter | St Jude Medical Cardiac Rhythm Management Division |
| 2015-01-21 | Z-0950-2015 | Class II | Labeled in part: I Color Complete / Color Lens | Intertrade Imports Inc. |
| 2015-01-21 | Z-0951-2015 | Class II | Labeled in part: I Color Complete / Crazy Lens | Intertrade Imports Inc. |
| 2015-01-21 | Z-0952-2015 | Class II | POWEREASE Instruments Set Screw Breakoff Instrument | Medtronic Sofamor Danek USA Inc |
| 2015-01-21 | Z-0953-2015 | Class II | The ATTUNE INTUITION Impaction Handle is a re-useable instrument… | DePuy Orthopaedics, Inc. |
| 2015-01-21 | Z-0954-2015 | Class II | GE Healthcare | GE Healthcare |
| 2015-01-21 | Z-0956-2015 | Class II | iPlan RT Dose is a stereotactic radiation treatment planning system… | Brainlab AG |
| 2015-01-21 | Z-0957-2015 | Class II | iPlan RT is a radiation treatment planning system that is intended… | Brainlab AG |
| 2015-01-21 | Z-0958-2015 | Class II | Philips Expression MR200 MRI Patient Monitoring System | Invivo Corporation |
| 2015-01-21 | Z-0959-2015 | Class II | IC PROFILER-MR | Sun Nuclear Corporation |
| 2015-01-21 | Z-0960-2015 | Class II | Symbia T and Symbia T2 computer tomography systems | Siemens Medical Solutions USA, Inc. |
| 2015-01-21 | Z-0963-2015 | Class II | HeartStart MRx Monitor/Defibrillator | Philips Medical Systems, Inc. |
| 2015-01-21 | Z-0964-2015 | Class II | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile… | Mentor Texas, LP. |