| Reported | Recall | Class | Product | Firm |
|---|
| 2014-12-03 | Z-0430-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0431-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0432-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0433-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0434-2015 | Class II | 8MM MONOPOLAR CURVED SCISSORS | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0435-2015 | Class II | 8MM RESANO FORCEPS | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0436-2015 | Class II | 8MM PERMANENT CAUTERY HOOK | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0437-2015 | Class II | 8MM PERMANENT CAUTERY SPATULA | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0438-2015 | Class II | 8MM FENESTRATED BIPOLAR FORCEPS | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0439-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0440-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0441-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0442-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0443-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0444-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0445-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0446-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0447-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0448-2015 | Class II | 8MM | Intuitive Surgical, Inc. |
| 2014-12-03 | Z-0449-2015 | Class II | Remel TB Potassium Permanganate | Remel Inc |
| 2014-12-03 | Z-0450-2015 | Class II | BrightView product code: 882478 BrightView X product code: 882480… | Philips Medical Systems (Cleveland) Inc |
| 2014-12-03 | Z-0463-2015 | Class II | Abbott m2000sp | Abbott Molecular |
| 2014-12-03 | Z-0464-2015 | Class II | AlignRT- Intended for prescription use | Vision Rt Inc |
| 2014-12-03 | Z-0465-2015 | Class II | Oxoid Legionella Pneumo Groups 2-14 Latex Test | Remel Inc |
| 2014-12-03 | Z-0466-2015 | Class II | Oxoid Legionella Latex Test | Remel Inc |
| 2014-12-03 | Z-0467-2015 | Class II | Calcitonin ELISA Kit | Biomerica |
| 2014-12-03 | Z-0468-2015 | Class II | The J700 Floor Mounted Tube Stand | Summit Industries Inc. |
| 2014-12-03 | Z-0469-2015 | Class III | LUNA Chest | Novadaq Technologies, Inc. |
| 2014-12-03 | Z-0470-2015 | Class III | Non-sterile drape | Novadaq Technologies, Inc. |
| 2014-12-03 | Z-0471-2015 | Class II | Cardiac Function Analysis Software Product Data No | Toshiba American Medical Systems Inc |
| 2014-12-03 | Z-0472-2015 | Class II | Cardiac Function Analysis Software Product Data No | Toshiba American Medical Systems Inc |
| 2014-12-03 | Z-0473-2015 | Class II | IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal… | Philips Medical Systems (Cleveland) Inc |
| 2014-12-03 | Z-0474-2015 | Class II | ARCHITECT Total T3 Reagent Kit | Abbott Ireland Diagnostics Division |
| 2014-12-03 | Z-0475-2015 | Class II | Dharma Cavity Varnish with Fluoride | Dharma Research, Inc. |
| 2014-12-03 | Z-0476-2015 | Class II | Dharma Cavity Varnish 15mL | Dharma Research, Inc. |
| 2014-12-03 | Z-0477-2015 | Class II | 7F NeuroFlo Catheter | ZOLL Circulation, Inc. |
| 2014-12-03 | Z-0483-2015 | Class II | Cannulaide | Beevers Manufacturing & Supply, Inc. |
| 2014-12-03 | Z-0484-2015 | Class II | CooperSurgical LEEP RADIUS LOOP ELECTRODE | CooperSurgical, Inc. |
| 2014-12-03 | Z-0485-2015 | Class II | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The… | Respironics California Inc |
| 2014-12-03 | Z-2145-2014 | Class II | Instructions for Use for the blue endo MOREsolution Electromechanical… | Market-Tiers Inc |
| 2014-11-26 | Z-0214-2015 | Class III | ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning… | Siemens Healthcare Diagnostics, Inc |
| 2014-11-26 | Z-0215-2015 | Class II | AxoTrack I Sterile Procedure Kit 18G | Soma Access Systems LLC |
| 2014-11-26 | Z-0216-2015 | Class II | Transport Chair and Rollator in 1 | Silver Star Brands |
| 2014-11-26 | Z-0217-2015 | Class II | Edwards Lifesciences Vent Catheters | Edwards Lifesciences, LLC |
| 2014-11-26 | Z-0218-2015 | Class II | CyberKnife Robotic Radiosurgery System with the first generation IRIS… | Accuray Incorporated |
| 2014-11-26 | Z-0219-2015 | Class II | 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM | Synthes, Inc. |
| 2014-11-26 | Z-0220-2015 | Class II | LANX | Biomet Spine LLC. |
| 2014-11-26 | Z-0221-2015 | Class II | MOSAIQ Product Usage: MOSAIQ is an oncology information system used… | Elekta, Inc. |
| 2014-11-26 | Z-0222-2015 | Class II | MC-500 Multicolor Laser Photocoagulator using software version 2 | Nidek Inc |
| 2014-11-26 | Z-0223-2015 | Class II | Nidek Excimer Laser Corneal Surgery System | Nidek Inc |
| 2014-11-26 | Z-0224-2015 | Class II | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2 | Nidek Inc |
| 2014-11-26 | Z-0225-2015 | Class II | The MectaLIF Oblique Handle | Medacta Usa |
| 2014-11-26 | Z-0227-2015 | Class II | SideFire Directional Laser Probe | Monteris Medical Corp |
| 2014-11-26 | Z-0228-2015 | Class II | FullFire Diffusing Tip Laser Probe | Monteris Medical Corp |
| 2014-11-26 | Z-0229-2015 | Class III | ADVIA Centaur BNP Assay for in vitro diagnostic use in the… | Siemens Healthcare Diagnostics, Inc |
| 2014-11-26 | Z-0230-2015 | Class III | Etest¿ Ceftaroline | Biomerieux |
| 2014-11-26 | Z-0231-2015 | Class III | Etest¿ Ceftaroline | Biomerieux |
| 2014-11-26 | Z-0232-2015 | Class III | Etest¿ Ceftaroline | Biomerieux |
| 2014-11-26 | Z-0233-2015 | Class III | Etest¿ Ceftaroline | Biomerieux |
| 2014-11-26 | Z-0234-2015 | Class III | Etest¿ Ceftaroline | Biomerieux |
| 2014-11-26 | Z-0235-2015 | Class II | Siemens SimView NT and SimView NT with IDI simulation system… | Siemens Medical Solutions USA, Inc |
| 2014-11-26 | Z-0416-2015 | Class II | MediChoice Dual-Release Folding Walker with 5" wheel | Owens & Minor Distribution, Inc. |
| 2014-11-26 | Z-1578-2014 | Class II | BAG 9732315 MOUSE STERILE 15 PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1579-2014 | Class II | BIOPSY NEEDLE KIT | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1580-2014 | Class II | BIT 9733516 2 | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1581-2014 | Class II | DISP 9730950 STRL SPHERE | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1582-2014 | Class II | DISP 9730951 STRL SPHERE | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1583-2014 | Class II | DRAPE 9732722 TUBE STERILE O-ARM 20PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1584-2014 | Class II | ENT PRGM 9734636 ADD FUSION NAV AxiEM | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1585-2014 | Class II | INST 9731132 KIT CR REF FRAME DRIVER 5PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1586-2014 | Class II | INSTRUMENT TRACKER 9733533XOM ENT 1PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1587-2014 | Class II | KIT | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1588-2014 | Class II | MOUSE 9732721 STERILE O-ARM 10PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1589-2014 | Class II | PACK 9731975 TUMOR RESECTION AXIEM CR | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1590-2014 | Class II | PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1591-2014 | Class II | PATIENT TRACKER 9733534XOM ENT 1PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1592-2014 | Class II | PIN | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1593-2014 | Class II | PIN | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1594-2014 | Class II | SHUNT KIT 9733605 NON-INVASIVE | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1595-2014 | Class II | SPHERES 8801071 1/TRAY 12PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1596-2014 | Class II | SPHERES 8801075 5/TRAY 12PK | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1597-2014 | Class II | TRAJ GUIDE KIT | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1598-2014 | Class II | TRAJ GUIDE KIT | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1599-2014 | Class II | TUMOR RES | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1600-2014 | Class II | TUMOR RESECTION KIT 9733607 NON-INVASIVE | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1601-2014 | Class II | TUMOR RESECTION KIT 9733608 SKULL MOUNT | Medtronic Navigation, Inc. |
| 2014-11-26 | Z-1602-2014 | Class II | UPGRD PRGM 9734638 ADD AxiEM NAVIGATION | Medtronic Navigation, Inc. |
| 2014-11-19 | Z-0170-2015 | Class I | Rapid Neg BP Combo Panel Type 3 | Siemens Healthcare Diagnostics, Inc. |
| 2014-11-19 | Z-0171-2015 | Class I | Rapid Neg Urine Combo Panel Type 1 | Siemens Healthcare Diagnostics, Inc. |
| 2014-11-19 | Z-0181-2015 | Class II | Philips Medical Systems Allura Xper FD20C Radiological Imaging with… | Philips Medical Systems, Inc. |
| 2014-11-19 | Z-0182-2015 | Class II | Philips Medical Systems Allura Xper FD20C with software version R8 | Philips Medical Systems, Inc. |
| 2014-11-19 | Z-0183-2015 | Class II | Artis zeego systems | Siemens Medical Solutions USA, Inc |
| 2014-11-19 | Z-0184-2015 | Class II | GE Healthcare Infinia | GE Healthcare, LLC |
| 2014-11-19 | Z-0185-2015 | Class II | GE Healthcare Varicam/VG and VG Hawkeye devices | GE Healthcare, LLC |
| 2014-11-19 | Z-0186-2015 | Class II | Discovery NM/CT 670 dual detector free-geometry integrated nuclear… | GE Healthcare, LLC |
| 2014-11-19 | Z-0187-2015 | Class II | Discovery NM 630 | GE Healthcare, LLC |
| 2014-11-19 | Z-0188-2015 | Class II | Optima NM/CT 640 | GE Healthcare, LLC |
| 2014-11-19 | Z-0189-2015 | Class II | Brivo NM615 | GE Healthcare, LLC |
| 2014-11-19 | Z-0190-2015 | Class II | MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase… | Philips Medical Systems (Cleveland) Inc |
| 2014-11-19 | Z-0191-2015 | Class II | Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for… | Davol, Inc., Subs. C. R. Bard, Inc. |
| 2014-11-19 | Z-0192-2015 | Class II | OEC¿ UroView 2800 | GE OEC Medical Systems, Inc |
| 2014-11-19 | Z-0193-2015 | Class II | OEC¿ MiniView 6800 | GE OEC Medical Systems, Inc |
| 2014-11-19 | Z-0194-2015 | Class II | FlexiView 8800 Digital Mobile Imaging System | GE OEC Medical Systems, Inc |
| 2014-11-19 | Z-0195-2015 | Class II | Series OEC 9800 | GE OEC Medical Systems, Inc |
| 2014-11-19 | Z-0196-2015 | Class II | The 5085 is a general surgical table with high patient weight capacity | Steris Corporation |
| 2014-11-19 | Z-0197-2015 | Class II | Integra Titan Reverse Shoulder System right and left head cutting… | Integra LifeSciences Corp. |
| 2014-11-19 | Z-0198-2015 | Class II | Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is… | Zimmer, Inc. |
| 2014-11-19 | Z-0199-2015 | Class II | ATTUNE Intuition Distal Femoral Jig | DePuy Orthopaedics, Inc. |
| 2014-11-19 | Z-0200-2015 | Class II | Oxoid Legionella BCYE Growth Supplement SR0110A | Remel Inc |
| 2014-11-19 | Z-0201-2015 | Class II | Integra Licox Pt02 Monitor | Integra LifeSciences Corp. |
| 2014-11-19 | Z-0202-2015 | Class II | GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct… | Medacta Usa |
| 2014-11-19 | Z-0204-2015 | Class II | Transport Rollator with Padded Seat | Roscoe Medical Inc |
| 2014-11-19 | Z-0205-2015 | Class II | Medtronic Launcher Coronary Guide Catheter | Medtronic Vascular |
| 2014-11-19 | Z-0207-2015 | Class III | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1… | CooperSurgical, Inc. |
| 2014-11-19 | Z-0208-2015 | Class III | CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary-… | CooperSurgical, Inc. |
| 2014-11-19 | Z-0209-2015 | Class II | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit | American Medical Systems, Inc. |
| 2014-11-19 | Z-0210-2015 | Class II | Fisher and Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. |
| 2014-11-19 | Z-0211-2015 | Class II | Cardiohelp-I System Product Usage: A blood oxygenation and carbon… | Maquet Cardiovascular Us Sales, Llc |
| 2014-11-19 | Z-0212-2015 | Class III | IMMULITE Calcitonin Control Module | Siemens Healthcare Diagnostics, Inc. |
| 2014-11-19 | Z-0213-2015 | Class II | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is… | Masimo Corporation |
| 2014-11-12 | Z-0084-2015 | Class I | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports | Baxter Healthcare Corp |
| 2014-11-12 | Z-0085-2015 | Class I | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports | Baxter Healthcare Corp |
| 2014-11-12 | Z-0125-2015 | Class I | Ovation Prime Abdominal Stent Graft System | Trivascular, Inc |
| 2014-11-12 | Z-0156-2015 | Class II | Terumo Custom Cardioplegia Delivery Set | Terumo Cardiovascular Systems Corp |
| 2014-11-12 | Z-0157-2015 | Class II | Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR… | Terumo Cardiovascular Systems Corp |
| 2014-11-12 | Z-0158-2015 | Class II | Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage:… | Terumo Cardiovascular Systems Corp |
| 2014-11-12 | Z-0159-2015 | Class II | Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog… | Terumo Cardiovascular Systems Corp |
| 2014-11-12 | Z-0160-2015 | Class II | Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and… | Terumo Cardiovascular Systems Corp |
| 2014-11-12 | Z-0161-2015 | Class II | Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product… | Terumo Cardiovascular Systems Corp |
| 2014-11-12 | Z-0162-2015 | Class II | Merit Maestro Microcatheter | Merit Medical Systems, Inc. |
| 2014-11-12 | Z-0163-2015 | Class II | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone… | C.R. Bard, Inc. |
| 2014-11-12 | Z-0164-2015 | Class II | Siemens Calibrator E | Siemens Healthcare Diagnostics, Inc |
| 2014-11-12 | Z-0165-2015 | Class II | UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric… | Zimmer Surgical Inc |
| 2014-11-12 | Z-0166-2015 | Class II | CADD-Solis Medication Safety Software | Smiths Medical ASD, Inc. |
| 2014-11-12 | Z-0167-2015 | Class II | Prescription eyeglass safety lenses | Eyemart Express Ltd |
| 2014-11-12 | Z-0168-2015 | Class II | COMPASS | Iba Dosimetry Gmbh |
| 2014-11-12 | Z-0169-2015 | Class II | Elite XPL | Cynosure, Inc. |
| 2014-11-12 | Z-0172-2015 | Class II | Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The… | Stryker Instruments Div. of Stryker Corporation |
| 2014-11-12 | Z-0173-2015 | Class II | Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The… | Stryker Instruments Div. of Stryker Corporation |
| 2014-11-12 | Z-0174-2015 | Class II | Straumann Bone Level Implant 04 | Straumann USA, LLC |
| 2014-11-12 | Z-0175-2015 | Class II | Access 2 Immunoassay Systems | Beckman Coulter Inc. |
| 2014-11-12 | Z-0176-2015 | Class II | UniCel DxC 600i SYNCHRON Access Clinical Analyzer | Beckman Coulter Inc. |
| 2014-11-12 | Z-0177-2015 | Class II | St | St Jude Medical |
| 2014-11-12 | Z-0178-2015 | Class II | Cardiopulmonary bypass connector | Dokitz NovoSci |
| 2014-11-12 | Z-0179-2015 | Class II | Thyroglobulin | Leica Microsystems, Inc. |
| 2014-11-05 | Z-0020-2015 | Class II | Proteus 235 Proton Therapy System for cancer treatment | Ion Beam Applications S.A. |
| 2014-11-05 | Z-0095-2015 | Class I | The GemStar Power Supply is an accessory for the GemStar Infusion Pump | Hospira Inc. |
| 2014-11-05 | Z-0096-2015 | Class I | The GemStar Power Supply is an accessory for the GemStar Infusion Pump | Hospira Inc. |
| 2014-11-05 | Z-0112-2015 | Class I | Covidien Puritan Bennett 980 Ventilator | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| 2014-11-05 | Z-0124-2015 | Class II | Spirotome" Soft-Tissue Biopsy Needle Set | Cook Medical Incorporated |
| 2014-11-05 | Z-0126-2015 | Class II | Equate Moisture Last Multi-Purpose Solution | Bausch & Lomb Inc- Greenville Solutions Plant |
| 2014-11-05 | Z-0127-2015 | Class II | Dimension Vista¿ HbA1c | Siemens Healthcare Diagnostics, Inc. |
| 2014-11-05 | Z-0128-2015 | Class II | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc |
| 2014-11-05 | Z-0129-2015 | Class II | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay… | Siemens Healthcare Diagnostics, Inc |
| 2014-11-05 | Z-0130-2015 | Class II | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay… | Siemens Healthcare Diagnostics, Inc |
| 2014-11-05 | Z-0131-2015 | Class II | Lipase Reagent | Abbott Laboratories, Inc |
| 2014-11-05 | Z-0132-2015 | Class II | Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump… | Maquet Cardiovascular, LLC |
| 2014-11-05 | Z-0133-2015 | Class II | SAM Junctional Tourniquet | Sam Medical Products |
| 2014-11-05 | Z-0134-2015 | Class III | ProClear Toric contact lenses are made from a material containing 62%… | Cooper Vision Caribbean Corp. |
| 2014-11-05 | Z-0135-2015 | Class II | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1 | Abbott Laboratories |
| 2014-11-05 | Z-0136-2015 | Class II | Animas Vibe Insulin Infusion Pump | Animas Corporation |
| 2014-11-05 | Z-0137-2015 | Class II | Animas Vibe Insulin Infusion Pump and System | Animas Corporation |
| 2014-11-05 | Z-0138-2015 | Class III | Biatain Super Non-Adhesive | Coloplast Manufacturing US, LLC |
| 2014-11-05 | Z-0139-2015 | Class II | ThermoCool SmartTouch Navigation Catheters | Biosense Webster, Inc. |
| 2014-11-05 | Z-0140-2015 | Class II | Monoswift PGCL [poly | C P Medical, Inc. |
| 2014-11-05 | Z-0141-2015 | Class II | TITAN Operating Room Table Patient positioning during surgery | Trumpf Medical Systems, Inc. |
| 2014-11-05 | Z-0142-2015 | Class II | DMI Duro-Med Industries Rollator Transport Chair | Briggs Medical Service Company d.b.a. Mabis |
| 2014-11-05 | Z-0143-2015 | Class II | Merge Healthcare | Merge Healthcare, Inc. |
| 2014-11-05 | Z-0144-2015 | Class II | IMRIS Operating Room table | IMRIS Inc |
| 2014-11-05 | Z-0145-2015 | Class II | Parker Eclipse Probe Cover | Parker Laboratories, Inc. |
| 2014-11-05 | Z-0146-2015 | Class II | ACCU-CHEK Spirit Combo insulin infusion pump sold as part of… | Roche Diagnostics Operations, Inc. |
| 2014-11-05 | Z-0147-2015 | Class II | Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open… | CooperSurgical, Inc. D.B.A. Lone Star Medical Products |
| 2014-11-05 | Z-0148-2015 | Class II | siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method… | Siemens Healthcare Diagnostics, Inc. |
| 2014-11-05 | Z-0149-2015 | Class II | Freedom EVO-2 100 Base Unit | Tecan US, Inc. |
| 2014-11-05 | Z-0150-2015 | Class II | APTUS Ulna Shortening 2 | Medartis, Inc. |
| 2014-11-05 | Z-0151-2015 | Class II | Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital… | Joerns Healthcare |
| 2014-11-05 | Z-0152-2015 | Class II | Laksell Gamma Knife Perfexion | Elekta, Inc. |
| 2014-11-05 | Z-0153-2015 | Class II | Spline Twist Implant | Zimmer Dental Inc |
| 2014-11-05 | Z-0154-2015 | Class II | Tapered Screw-Vent Implant | Zimmer Dental Inc |
| 2014-11-05 | Z-0155-2015 | Class II | Coloplast Conveen Urine Collection Leg Bag | Coloplast Manufacturing US, LLC |
| 2014-10-29 | Z-0008-2015 | Class I | Esprit V1000 and V200 Ventilators | Respironics California Inc |
| 2014-10-29 | Z-0086-2015 | Class II | Siemens Mammomat Inspiration mammography systems | Siemens Medical Solutions USA, Inc |
| 2014-10-29 | Z-0087-2015 | Class II | Boston Scientific COGNIS CRT-D | Boston Scientific CRM Corp |
| 2014-10-29 | Z-0088-2015 | Class II | Boston Scientific TELIGEN | Boston Scientific CRM Corp |
| 2014-10-29 | Z-0089-2015 | Class II | Codman EDS 3 Drainage System with Ventricular Catheter | Codman & Shurtleff, Inc. |
| 2014-10-29 | Z-0090-2015 | Class II | Codman EDS 3 Drainage System | Codman & Shurtleff, Inc. |
| 2014-10-29 | Z-0091-2015 | Class II | Codman Lumbar Drainage Catheter Kit II with EDS 3 | Codman & Shurtleff, Inc. |
| 2014-10-29 | Z-0092-2015 | Class II | DePuy Synthes Radiolucent Retractor | Synthes, Inc. |
| 2014-10-29 | Z-0093-2015 | Class II | McKesson Cardiology Hemo | Mckesson Information Solutions LLC |
| 2014-10-29 | Z-0094-2015 | Class II | Continuum Acetabular System Trabecular Metal Shell with Multi Holes | Zimmer, Inc. |
| 2014-10-29 | Z-0097-2015 | Class II | Suction canisters labels as follows: 1) DeRoyal | DeRoyal Industries Inc |
| 2014-10-29 | Z-0098-2015 | Class II | DeRoyal | DeRoyal Industries Inc |
| 2014-10-29 | Z-0099-2015 | Class II | CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" | Intra Pump Infusion Systems |
| 2014-10-29 | Z-0100-2015 | Class II | GYRUS ACMI | Gyrus Medical, Inc |
| 2014-10-29 | Z-0101-2015 | Class II | Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery… | Estill Medical Technologies, Inc |
| 2014-10-29 | Z-0102-2015 | Class II | Siemens ADVIA Centaur¿ Systems HBc Total | Siemens Healthcare Diagnostics, Inc |
| 2014-10-29 | Z-0103-2015 | Class II | ADVIA Centaur¿¿ Systems HBc Total | Siemens Healthcare Diagnostics, Inc |
| 2014-10-29 | Z-0104-2015 | Class II | Philips IntelliVue Monitors with software revisions J | Philips Medical Systems, Inc. |
| 2014-10-29 | Z-0105-2015 | Class II | Philips Avalon Monitors with software revision J | Philips Medical Systems, Inc. |
| 2014-10-29 | Z-0106-2015 | Class II | Box Label: 3 mm Cueva Electrode Kit | Ad-Tech Medical Instrument Corporation |