| Reported | Recall | Class | Product | Firm |
|---|
| 2017-02-08 | Z-1125-2017 | Class II | Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10 | Covidien LLC |
| 2017-02-08 | Z-1126-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1127-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1128-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1129-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1130-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1131-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1132-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1133-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1134-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1135-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-08 | Z-1136-2017 | Class II | Intact Disposable Wands | Medtronic Advanced Energy, LLC |
| 2017-02-01 | Z-0922-2017 | Class II | Allura Xper FD20 722012 is intended for: Cardiovascular and vascular… | Philips Electronics North America Corporation |
| 2017-02-01 | Z-0923-2017 | Class II | Allura Xper FD10 722026 is intended for: Cardiovascular and vascular… | Philips Electronics North America Corporation |
| 2017-02-01 | Z-0924-2017 | Class II | Allura Xper FD20 R8 | Philips Electronics North America Corporation |
| 2017-02-01 | Z-0925-2017 | Class II | Allura Xper FD20/15 R8 | Philips Electronics North America Corporation |
| 2017-02-01 | Z-1057-2017 | Class II | Chord-X Chordal Sizer is designed to assist in determining the proper… | On-X Life Technologies, Inc. |
| 2017-02-01 | Z-1058-2017 | Class II | Brilliance iCT | Philips Medical Systems (Cleveland) Inc |
| 2017-02-01 | Z-1059-2017 | Class II | OEC 9800 | GE OEC Medical Systems, Inc |
| 2017-02-01 | Z-1060-2017 | Class II | OEC 9900 Elite | GE OEC Medical Systems, Inc |
| 2017-02-01 | Z-1061-2017 | Class II | Velara Generator with an old Firmware version used with Philips… | Philips Electronics North America Corporation |
| 2017-02-01 | Z-1062-2017 | Class II | Velara Generator with an old Firmware version used with the Philips… | Philips Electronics North America Corporation |
| 2017-02-01 | Z-1063-2017 | Class II | Juno DRF | Villa Radiology Systems LLC |
| 2017-02-01 | Z-1064-2017 | Class II | Apollo: Models: 9784000131 | Villa Radiology Systems LLC |
| 2017-02-01 | Z-1065-2017 | Class II | Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of… | Villa Radiology Systems LLC |
| 2017-02-01 | Z-1066-2017 | Class II | Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of… | Villa Radiology Systems LLC |
| 2017-02-01 | Z-1067-2017 | Class II | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser… | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1068-2017 | Class II | Human lgG4 Subclass kit for use on the Beckman Coulter AU" series… | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1069-2017 | Class II | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche… | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1070-2017 | Class II | Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1071-2017 | Class II | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II… | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1072-2017 | Class II | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ… | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1073-2017 | Class II | MininephThl Human lgG4 Kit Product Code: ZK009 | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1074-2017 | Class II | Unna-Z | Medline Industries Inc |
| 2017-02-01 | Z-1075-2017 | Class II | Rigid Laryngostroboscopes The Rigid Laryngostroboscopes | Pentax of America Inc |
| 2017-02-01 | Z-1076-2017 | Class II | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system | INO Therapeutics (dba Ikaria) |
| 2017-02-01 | Z-1077-2017 | Class II | Cobas b 123 POC system The cobas b 123 POC system is a fully… | Roche Diagnostics Operations, Inc. |
| 2017-02-01 | Z-1078-2017 | Class II | Sekisui Diagnostics Ammonia L3K¿ Assay | Sekisui Diagnostics P.E.I. Inc. |
| 2017-02-01 | Z-1079-2017 | Class II | Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain | Atrium Medical Corporation |
| 2017-02-01 | Z-1080-2017 | Class II | Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean… | Atrium Medical Corporation |
| 2017-02-01 | Z-1081-2017 | Class II | Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320… | Atrium Medical Corporation |
| 2017-02-01 | Z-1082-2017 | Class II | Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean… | Atrium Medical Corporation |
| 2017-02-01 | Z-1083-2017 | Class II | Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single… | Atrium Medical Corporation |
| 2017-02-01 | Z-1084-2017 | Class II | Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis… | Atrium Medical Corporation |
| 2017-02-01 | Z-1085-2017 | Class II | Atrium Medical 3620-100: Oasis dual chamber drain with in-line… | Atrium Medical Corporation |
| 2017-02-01 | Z-1086-2017 | Class II | Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis… | Atrium Medical Corporation |
| 2017-02-01 | Z-1087-2017 | Class II | Atrium Medical 400 Series Express Drains as follows: 4000-100N… | Atrium Medical Corporation |
| 2017-02-01 | Z-1088-2017 | Class II | Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage:… | Atrium Medical Corporation |
| 2017-02-01 | Z-1089-2017 | Class III | Optilite IgG4 Kit Product Code: LK009 | The Binding Site Group, Ltd. |
| 2017-02-01 | Z-1090-2017 | Class II | cobas p 612 pre-analytical system | Roche Diagnostics Corporation |
| 2017-02-01 | Z-1091-2017 | Class II | Merge Hemo software | Merge Healthcare, Inc. |
| 2017-02-01 | Z-1092-2017 | Class II | Tina-Quant | Roche Diagnostics Operations, Inc. |
| 2017-02-01 | Z-1093-2017 | Class II | Tryptic Soy Agar | Acumedia Manufacturers, Inc. |
| 2017-02-01 | Z-1094-2017 | Class II | Maintenance Kit PH1 | Baxter Healthcare Corporation |
| 2017-02-01 | Z-1095-2017 | Class II | Maintenance Kit PH2 | Baxter Healthcare Corporation |
| 2017-02-01 | Z-1096-2017 | Class II | Hitachi Oasis MRI System | Hitachi Medical Systems America Inc |
| 2017-02-01 | Z-1097-2017 | Class II | SCC Soft Computer Softbank II software Product Usage: Supports single… | Soft Computer Consultants, Inc. |
| 2017-02-01 | Z-1098-2017 | Class II | Softbank software Product Usage: Decision support software for… | Soft Computer Consultants, Inc. |
| 2017-02-01 | Z-1099-2017 | Class II | Accu-Chek Connect Diabetes Management App | Roche Diabetes Care, Inc. |
| 2017-02-01 | Z-1100-2017 | Class III | AutoDELFIA¿ Plate Processor | PerkinElmer Health Sciences, Inc. |
| 2017-02-01 | Z-1101-2017 | Class III | Program Update Package AutoDELFIA¿ 3 | PerkinElmer Health Sciences, Inc. |
| 2017-02-01 | Z-1102-2017 | Class III | DELFIA¿ PC with V3 | PerkinElmer Health Sciences, Inc. |
| 2017-02-01 | Z-1104-2017 | Class II | ProSpore 4 mL Ampoule Biological indicator for steam sterilization | Mesa Laboratories Inc |
| 2017-02-01 | Z-1105-2017 | Class II | NORMFlow H-110 Irrigation Fluid Warmer | Smiths Medical ASD, Inc. |
| 2017-02-01 | Z-1106-2017 | Class II | Philips Cisco 3850 layer 3 switch | Philips Electronics North America Corporation |
| 2017-01-25 | Z-0950-2017 | Class I | Alaris Pump Module | CareFusion 303, Inc. |
| 2017-01-25 | Z-0968-2017 | Class I | Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One… | BARD PERIPHERAL VASCULAR, INC |
| 2017-01-25 | Z-0969-2017 | Class I | Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product… | BARD PERIPHERAL VASCULAR, INC |
| 2017-01-25 | Z-0970-2017 | Class I | Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F… | BARD PERIPHERAL VASCULAR, INC |
| 2017-01-25 | Z-0976-2017 | Class I | MagSIL | BioMerieux SA |
| 2017-01-25 | Z-0977-2017 | Class I | NucliSENS magnetic extraction reagents | BioMerieux SA |
| 2017-01-25 | Z-1018-2017 | Class II | Optilite Analyser | The Binding Site Group, Ltd. |
| 2017-01-25 | Z-1023-2017 | Class II | Medacta International SA | Medacta Usa Inc |
| 2017-01-25 | Z-1024-2017 | Class II | RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High… | Zimmer Biomet, Inc. |
| 2017-01-25 | Z-1025-2017 | Class II | Active Articulation ArComXL Polyethylene Bearings Active Articulation… | Zimmer Biomet, Inc. |
| 2017-01-25 | Z-1026-2017 | Class II | Fresenius 2008T Series Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC |
| 2017-01-25 | Z-1027-2017 | Class II | Fresenius 2008K Series : Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC |
| 2017-01-25 | Z-1028-2017 | Class II | Fresenius 2008K2 Series : Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC |
| 2017-01-25 | Z-1029-2017 | Class II | Fresenius 2008K@home Series : Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC |
| 2017-01-25 | Z-1030-2017 | Class II | Novation Cemented Plus Femoral Stem | Exactech, Inc. |
| 2017-01-25 | Z-1031-2017 | Class II | AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner | Exactech, Inc. |
| 2017-01-25 | Z-1032-2017 | Class II | Alteon Neck Preserving Stem | Exactech, Inc. |
| 2017-01-25 | Z-1033-2017 | Class II | PREMIER EHEC and PREMIER EHEC Bulk | Meridian Bioscience Inc |
| 2017-01-25 | Z-1034-2017 | Class II | NanoTips 30g 20pk | Ultradent Products, Inc. |
| 2017-01-25 | Z-1035-2017 | Class II | AFX Endovascular AAA System | Endologix |
| 2017-01-25 | Z-1037-2017 | Class II | AFX Endovascular AAA System | Endologix |
| 2017-01-25 | Z-1038-2017 | Class II | AFX Endovascular AAA System | Endologix |
| 2017-01-25 | Z-1039-2017 | Class II | AFX Endovascular AAA System | Endologix |
| 2017-01-25 | Z-1040-2017 | Class III | AutoMate 2500 Family Catalog No | Beckman Coulter Inc. |
| 2017-01-25 | Z-1041-2017 | Class II | Smith & Nephew | Smith & Nephew, Inc. |
| 2017-01-25 | Z-1042-2017 | Class II | Smith & Nephew | Smith & Nephew, Inc. |
| 2017-01-25 | Z-1043-2017 | Class II | Optilite Freelite Lambda Free Kit Product Code: LK018 | The Binding Site Group, Ltd. |
| 2017-01-25 | Z-1044-2017 | Class II | Monaco RTP System | Elekta, Inc. |
| 2017-01-25 | Z-1045-2017 | Class II | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3 | DICOM GRID INC |
| 2017-01-25 | Z-1046-2017 | Class II | Merge Cardio software | Merge Healthcare, Inc. |
| 2017-01-25 | Z-1047-2017 | Class II | AFX Endovascular AAA System | Endologix |
| 2017-01-25 | Z-1048-2017 | Class II | AFX Endovascular AAA System Item Number Item Description F0070305… | Endologix |
| 2017-01-25 | Z-1049-2017 | Class II | AFX2 Endovascular AAA System Item No | Endologix |
| 2017-01-25 | Z-1050-2017 | Class II | Human Lambda Free SPAPlus Kit Product Code: LK018 | The Binding Site Group, Ltd. |
| 2017-01-25 | Z-1051-2017 | Class II | Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R… | Great Basin Scientific, Inc. |
| 2017-01-25 | Z-1052-2017 | Class II | Carestream Touch Prime | Carestream Health Inc |
| 2017-01-25 | Z-1053-2017 | Class II | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018 | The Binding Site Group, Ltd. |
| 2017-01-25 | Z-1054-2017 | Class II | AFX Endovascular AAA System | Endologix |
| 2017-01-25 | Z-1055-2017 | Class II | Digital RID Plate Reader and Software Product Code: AD400 | The Binding Site Group, Ltd. |
| 2017-01-25 | Z-1056-2017 | Class II | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for… | Baxter Healthcare Corporation |
| 2017-01-18 | Z-0951-2017 | Class II | Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus… | Natus Manufacturing Limited |
| 2017-01-18 | Z-0952-2017 | Class II | SCREW 02 | In2Bones, SAS |
| 2017-01-18 | Z-0953-2017 | Class II | NEO SCREW 02 | In2Bones, SAS |
| 2017-01-18 | Z-0954-2017 | Class II | NEOVIEW | In2Bones, SAS |
| 2017-01-18 | Z-0955-2017 | Class II | VOCO Futurabond M+ adhesive | Voco GmbH |
| 2017-01-18 | Z-0956-2017 | Class II | Oxford Fixed Lateral Bearing Size F Right | Zimmer Biomet, Inc. |
| 2017-01-18 | Z-0957-2017 | Class II | Straumann Drill 1 | Straumann Manufacturing, Inc. |
| 2017-01-18 | Z-0958-2017 | Class II | Straumann Twist Drill PRO ¿4 | Straumann Manufacturing, Inc. |
| 2017-01-18 | Z-0959-2017 | Class II | Femoral and Tibial Cutting Block Adapter Base | Brainlab AG |
| 2017-01-18 | Z-0960-2017 | Class II | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001… | Trilliant Surgical Ltd. |
| 2017-01-18 | Z-0961-2017 | Class II | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Implant Direct Sybron Manufacturing, LLC |
| 2017-01-18 | Z-0962-2017 | Class II | Amplia MRI" CRT -D SureScan" | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| 2017-01-18 | Z-0963-2017 | Class II | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT | Stryker Sustainability Solutions |
| 2017-01-18 | Z-0964-2017 | Class II | Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT | Stryker Sustainability Solutions |
| 2017-01-18 | Z-0965-2017 | Class II | EVOTECH Endoscope Cleaner and Reprocessor System 208V | Advanced Sterilization Products |
| 2017-01-18 | Z-0966-2017 | Class II | Ceres-C Standalone Cervical Interbody The product is a stand-alone… | Amendia, Inc |
| 2017-01-18 | Z-0967-2017 | Class II | SURESTEP Tray | C.R. Bard, Inc. |
| 2017-01-18 | Z-0971-2017 | Class II | Artis zee/zeego | Siemens Medical Solutions USA, Inc |
| 2017-01-18 | Z-0972-2017 | Class II | Artis Q/Q | Siemens Medical Solutions USA, Inc |
| 2017-01-18 | Z-0973-2017 | Class II | OEC 9800 | GE OEC Medical Systems, Inc |
| 2017-01-18 | Z-0974-2017 | Class II | OEC MiniView 6800 | GE OEC Medical Systems, Inc |
| 2017-01-18 | Z-0975-2017 | Class II | The OEC 9900 Elite mobile fluoroscopy system is designed to provide… | GE OEC Medical Systems, Inc |
| 2017-01-18 | Z-0978-2017 | Class II | Alcon Monarch III | Alcon Research, Ltd. |
| 2017-01-18 | Z-0979-2017 | Class II | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH | Siemens Healthcare Diagnostics, Inc. |
| 2017-01-18 | Z-0980-2017 | Class II | 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿ | ICU Medical, Inc. |
| 2017-01-18 | Z-0981-2017 | Class II | StatLock¿ PICC Plus Crescent Foam | Bard Access Systems |
| 2017-01-18 | Z-0982-2017 | Class II | StatLock¿ CV Plus w/Pigtail | Bard Access Systems |
| 2017-01-18 | Z-0983-2017 | Class II | Algerbrush-II Product Usage: Medical | Bausch & Lomb, Inc. |
| 2017-01-18 | Z-0984-2017 | Class II | Medline E-Z Lubricating Jelly | MEDLINE IND |
| 2017-01-18 | Z-0985-2017 | Class II | MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site | Bard Access Systems |
| 2017-01-18 | Z-0986-2017 | Class II | SafeStep¿ Huber Needle Set with Y-Injection Site | Bard Access Systems |
| 2017-01-18 | Z-0987-2017 | Class II | Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is… | Elekta, Inc. |
| 2017-01-18 | Z-0988-2017 | Class II | Tego Connector | ICU Medical, Inc. |
| 2017-01-18 | Z-0989-2017 | Class II | i | HEALTH ROBOTICS S.R.L. |
| 2017-01-18 | Z-0990-2017 | Class II | Eclipse Treatment Planning System version 13 | Varian Medical Systems, Inc. |
| 2017-01-18 | Z-0991-2017 | Class II | ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog… | ConforMIS, Inc. |
| 2017-01-18 | Z-0992-2017 | Class II | Biograph mCT S | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0993-2017 | Class II | Biograph mCT S | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0994-2017 | Class II | Biograph mCT X-4R | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0995-2017 | Class II | Biograph mCT S | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0996-2017 | Class II | Biograph mCT S | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0997-2017 | Class II | Biograph mCT X-3R | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0998-2017 | Class II | Bio mCT-S | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-0999-2017 | Class II | Biograph mCT-X w/TrueV Upgrade | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-1000-2017 | Class II | BIOGRAPH mCT 20 Excel | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-1001-2017 | Class II | Biograph mCT Flow Edge-4R | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-1002-2017 | Class II | Biograph mCT Flow 40-4R | Siemens Medical Solutions USA Inc. |
| 2017-01-18 | Z-1003-2017 | Class II | Halo Closed System Transfer Device | J&J Solutions, Inc. DBA Corvida Medical |
| 2017-01-18 | Z-1004-2017 | Class II | Brilliance iCT Product Usage: Computed Tomography X-ray systems… | Philips Medical Systems (Cleveland) Inc |
| 2017-01-18 | Z-1005-2017 | Class II | FV-RF | Philips Medical Systems (Cleveland) Inc |
| 2017-01-18 | Z-1006-2017 | Class II | IQon Spectral CT with software version 4 | Philips Medical Systems (Cleveland) Inc |
| 2017-01-18 | Z-1007-2017 | Class II | AxIEM Touch N Go Pointer Probe | Medtronic Navigation, Inc. |
| 2017-01-18 | Z-1008-2017 | Class II | REFLECTION | Smith & Nephew, Inc. |
| 2017-01-18 | Z-1009-2017 | Class II | Monaco RTP System Product Usage: Used to make treatment plans for… | Elekta, Inc. |
| 2017-01-18 | Z-1010-2017 | Class II | symmetry surgical ULTRA | Symmetry Surgical, Inc. |
| 2017-01-18 | Z-1011-2017 | Class II | symmetry surgical ULTRA | Symmetry Surgical, Inc. |
| 2017-01-18 | Z-1012-2017 | Class II | symmetry surgical ULTRA | Symmetry Surgical, Inc. |
| 2017-01-18 | Z-1013-2017 | Class II | UniCel DxH 800 Coulter Cellular Analysis System | Beckman Coulter Inc. |
| 2017-01-18 | Z-1014-2017 | Class II | DxH 600 Coulter Cellular Analysis System | Beckman Coulter Inc. |
| 2017-01-18 | Z-1015-2017 | Class II | Infant Warmer System | GE Healthcare, LLC |
| 2017-01-18 | Z-1016-2017 | Class II | Minibore Extension Set | Hospira Inc. |
| 2017-01-18 | Z-1017-2017 | Class II | Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System | Merge Healthcare, Inc. |
| 2017-01-18 | Z-1019-2017 | Class II | OPT Croutons is a synthetic bone substitute designed for the repair… | Acumed LLC |
| 2017-01-18 | Z-1020-2017 | Class II | Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment… | Stryker Howmedica Osteonics Corp. |
| 2017-01-11 | Z-0926-2017 | Class I | Normal Saline Flush 0 | Nurse Assist, Inc |
| 2017-01-11 | Z-0938-2017 | Class II | Boston Scientific | Boston Scientific Corporation |
| 2017-01-11 | Z-0939-2017 | Class II | DR Systems Unity PACS software | Merge Healthcare, Inc. |
| 2017-01-11 | Z-0940-2017 | Class II | TVC Imaging System model TVC-MC9 | Infraredx, Inc. |
| 2017-01-11 | Z-0941-2017 | Class II | G3 Opticage Expandable Interbody Fusion Device | Interventional Spine Inc |
| 2017-01-11 | Z-0942-2017 | Class II | TRU-Balance 3 Power Positioning Systems | Pride Mobility Products Corp |
| 2017-01-11 | Z-0943-2017 | Class II | PROFEMUR | MicroPort Orthopedics Inc. |
| 2017-01-11 | Z-0944-2017 | Class II | Modular REDAPT | Smith & Nephew, Inc. |
| 2017-01-11 | Z-0945-2017 | Class II | Modular SMF | Smith & Nephew, Inc. |
| 2017-01-11 | Z-0946-2017 | Class II | Modular Necks: The Modular SMF | Smith & Nephew, Inc. |
| 2017-01-11 | Z-0947-2017 | Class II | Gomco Circumcision Clamps with separate O-Ring Component: The device… | Aesculap Implant Systems LLC |
| 2017-01-11 | Z-0948-2017 | Class II | GalaSHAPE 3D | Tepha Incorporated |
| 2017-01-11 | Z-0949-2017 | Class II | PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit… | Merit Medical Systems, Inc. |
| 2017-01-04 | Z-0875-2017 | Class II | NeuViz 64 Multi-slice CT Scanner Systems | Neusoft Medical Systems Co., Ltd. |
| 2017-01-04 | Z-0876-2017 | Class II | NeuViz 128 Multi-slice CT Scanner System with software version 1 | Neusoft Medical Systems Co., Ltd. |
| 2017-01-04 | Z-0901-2017 | Class II | NIM EMG Endotracheal Tube | Medtronic Xomed, Inc. |
| 2017-01-04 | Z-0902-2017 | Class II | Specimen Gate Laboratory 5002-0180 | PerkinElmer Health Sciences, Inc. |
| 2017-01-04 | Z-0903-2017 | Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN… | ORTHO-CLINICAL DIAGNOSTICS |
| 2017-01-04 | Z-0904-2017 | Class II | Innova 2000 | GE Healthcare, LLC |
| 2017-01-04 | Z-0905-2017 | Class II | ADVANTX LCA | GE Healthcare, LLC |
| 2017-01-04 | Z-0906-2017 | Class II | ADVANTX LCLP+ | GE Healthcare, LLC |
| 2017-01-04 | Z-0907-2017 | Class II | ADVANTX LCN+ | GE Healthcare, LLC |
| 2017-01-04 | Z-0908-2017 | Class II | ADVANTX LCV+ | GE Healthcare, LLC |
| 2017-01-04 | Z-0909-2017 | Class II | Legacy | GE Healthcare, LLC |
| 2017-01-04 | Z-0910-2017 | Class II | Precision 500D | GE Healthcare, LLC |
| 2017-01-04 | Z-0911-2017 | Class II | Prestige II | GE Healthcare, LLC |
| 2017-01-04 | Z-0912-2017 | Class II | Prestige SI | GE Healthcare, LLC |
| 2017-01-04 | Z-0913-2017 | Class II | Prestige VH | GE Healthcare, LLC |
| 2017-01-04 | Z-0914-2017 | Class II | Prestilix | GE Healthcare, LLC |
| 2017-01-04 | Z-0915-2017 | Class II | RFX | GE Healthcare, LLC |
| 2017-01-04 | Z-0916-2017 | Class II | SFX | GE Healthcare, LLC |