| Reported | Recall | Class | Product | Firm |
|---|
| 2012-10-10 | Z-2473-2012 | Class II | 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203… | Zimmer, Inc. |
| 2012-10-10 | Z-2474-2012 | Class II | 00789502601 VerSys Femoral Head Provisional 26mm -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2475-2012 | Class II | 00789502801 VerSys Femoral Head Provisional 28mm -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2476-2012 | Class II | 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2477-2012 | Class II | 00789503601 VerSys Femoral Head Provisional 36mm -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2478-2012 | Class II | 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2479-2012 | Class II | 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22… | Zimmer, Inc. |
| 2012-10-10 | Z-2480-2012 | Class II | 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2481-2012 | Class II | 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2482-2012 | Class II | 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2483-2012 | Class II | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2484-2012 | Class II | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3 | Zimmer, Inc. |
| 2012-10-10 | Z-2485-2012 | Class II | Optilock 2 | Biomet, Inc. |
| 2012-10-10 | Z-2486-2012 | Class II | Optilock T15 AO Driver | Biomet, Inc. |
| 2012-10-10 | Z-2487-2012 | Class II | Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker… | Stryker Howmedica Osteonics Corp. |
| 2012-10-10 | Z-2488-2012 | Class II | Tabs Professional Monitor | Stanley Security Solutions, Inc. |
| 2012-10-10 | Z-2489-2012 | Class II | Tabs Professional Monitor | Stanley Security Solutions, Inc. |
| 2012-10-10 | Z-2490-2012 | Class II | Tabs Professional Monitor | Stanley Security Solutions, Inc. |
| 2012-10-10 | Z-2491-2012 | Class II | Tabs Professional Voice + Monitor | Stanley Security Solutions, Inc. |
| 2012-10-10 | Z-2492-2012 | Class II | Tabs Professional Voice + Monitor | Stanley Security Solutions, Inc. |
| 2012-10-10 | Z-2493-2012 | Class II | Cemented Tibial Drill Product Usage: The cemented tibial drill is… | Zimmer, Inc. |
| 2012-10-10 | Z-2494-2012 | Class II | Philips Digital Diagnost with patient carriage Model: 712050 with… | Philips Healthcare Inc. |
| 2012-10-03 | Z-2432-2012 | Class II | Covidien Duet TRS 45 3 | Covidien LP |
| 2012-10-03 | Z-2433-2012 | Class II | Covidien Duet TRS 45 3 | Covidien LP |
| 2012-10-03 | Z-2434-2012 | Class II | Covidien Duet TRS 45 4 | Covidien LP |
| 2012-10-03 | Z-2435-2012 | Class II | Covidien Duet TRS 45 4 | Covidien LP |
| 2012-10-03 | Z-2436-2012 | Class II | Covidien Duet TRS 60 3 | Covidien LP |
| 2012-10-03 | Z-2437-2012 | Class II | Covidien Duet TRS 60 3 | Covidien LP |
| 2012-10-03 | Z-2438-2012 | Class II | Covidien Duet TRS 60 4 | Covidien LP |
| 2012-10-03 | Z-2439-2012 | Class II | Covidien Duet TRS 60 4 | Covidien LP |
| 2012-10-03 | Z-2440-2012 | Class II | BP7561 OPTI CCA-TS B-Lac Cassette | OPTI Medical Systems, Inc |
| 2012-10-03 | Z-2441-2012 | Class II | Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1 | Cordis Corporation |
| 2012-10-03 | Z-2442-2012 | Class II | Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1 | Cordis Corporation |
| 2012-10-03 | Z-2443-2012 | Class II | Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage:… | Terumo Cardiovascular Systems Corporation |
| 2012-10-03 | Z-2444-2012 | Class II | SharePlan 1 | RAYSEARCH LABORATORIES AB |
| 2012-10-03 | Z-2445-2012 | Class III | Trinity Biotech | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| 2012-10-03 | Z-2446-2012 | Class II | Embolectomy Catheters | Applied Medical Resources Corp |
| 2012-10-03 | Z-2447-2012 | Class II | Biliary Catheters | Applied Medical Resources Corp |
| 2012-10-03 | Z-2448-2012 | Class II | Irrigation Catheters | Applied Medical Resources Corp |
| 2012-10-03 | Z-2449-2012 | Class II | Terumo Advanced Perfusion System 1 Flow Module indicated for use in… | Terumo Cardiovascular Systems Corporation |
| 2012-10-03 | Z-2450-2012 | Class II | Armada 35/ Armada 35 LL PTA Catheters | Abbott Vascular |
| 2012-10-03 | Z-2451-2012 | Class II | Computed Tomography X-Ray Systems | Philips Medical Systems (Cleveland) Inc |
| 2012-10-03 | Z-2452-2012 | Class II | Hologic Fluoroscan Mini C-Arm Model with InSight2 | Hologic, Inc. |
| 2012-10-03 | Z-2453-2012 | Class II | Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version… | Hologic, Inc. |
| 2012-10-03 | Z-2454-2012 | Class II | Progel Pleural Air Leak Sealant | Neomend Inc |
| 2012-10-03 | Z-2455-2012 | Class II | ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source | Linvatec Corp. dba ConMed Linvatec |
| 2012-10-03 | Z-2456-2012 | Class II | ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal… | Linvatec Corp. dba ConMed Linvatec |
| 2012-10-03 | Z-2457-2012 | Class II | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the… | Integra Limited |
| 2012-10-03 | Z-2458-2012 | Class II | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the… | Integra Limited |
| 2012-10-03 | Z-2459-2012 | Class II | Boston Scientific | Greatbatch Medical |
| 2012-10-03 | Z-2460-2012 | Class II | Alere Triage TOX Drug Screen 9 Panel | Alere San Diego, Inc. |
| 2012-10-03 | Z-2461-2012 | Class II | Invacare¿ I-Fit" Shower Chair | Invacare Corporation |
| 2012-10-03 | Z-2462-2012 | Class II | Varian brand Eclipse Treatment Planning System | Varian Medical Systems, Inc. Oncology Systems |
| 2012-10-03 | Z-2463-2012 | Class II | DEXIS Imaging Suite | Imaging Sciences International, LLC |
| 2012-10-03 | Z-2464-2012 | Class II | Siemens Magnetom Skyra | Siemens Medical Solutions USA, Inc |
| 2012-10-03 | Z-2465-2012 | Class II | Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost | Philips Healthcare Inc. |
| 2012-10-03 | Z-2466-2012 | Class II | BariAir Therapy System The BariAir Therapy System is a risk… | KCI USA, Inc. |
| 2012-10-03 | Z-2467-2012 | Class II | KY LIQUIBEADS Vaginal Moisturizer | Mc-NEIL-PPC, Inc. |
| 2012-10-03 | Z-2468-2012 | Class II | TSX-301A/2 Aquilion One CT System | Toshiba American Medical Systems Inc |
| 2012-10-03 | Z-2469-2012 | Class II | Catheter Irrigation Set labeled in part: ***24K Arthroscopy… | Linvatec Corp. dba ConMed Linvatec |
| 2012-10-03 | Z-2470-2012 | Class II | This voluntary medical device correction is related to Alcon products… | Alcon Research, LTD. |
| 2012-10-03 | Z-2471-2012 | Class II | UltraFlow HPC Flow Directed Micro Catheter | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| 2012-10-03 | Z-2472-2012 | Class II | Marathon Flow Directed Micro Catheter | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| 2012-09-26 | Z-2349-2012 | Class I | CMS-4501-R1 Custom HSG Tray containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2350-2012 | Class I | CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2351-2012 | Class I | CMS-4316 Custom Vein Tray containing 4 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2352-2012 | Class I | CMS-8450-R1 Custom Vein Tray containing 4 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2353-2012 | Class I | CMS-2586 Custom Amnio Tray containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2354-2012 | Class I | CMS-8162-R1 Fox Chase Specials Pack containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2355-2012 | Class I | CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington… | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2356-2012 | Class I | CMS-8495-R5 Custom Vein Tray containing 4 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2357-2012 | Class I | CMS-4873 Custom CT Biopsy Tray | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2358-2012 | Class I | CMS-4975 HSG Tray containing 4 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2359-2012 | Class I | CMS-5284 Custom Myelogram Tray containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2360-2012 | Class I | BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-26 | Z-2378-2012 | Class II | The product affected by this notice is sold under the trade name… | RAYSEARCH LABORATORIES AB |
| 2012-09-26 | Z-2379-2012 | Class II | HALO Flex Energy Generators Manufactured by B¿RRX Medical | Covidien LLC |
| 2012-09-26 | Z-2380-2012 | Class II | Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview… | Zoe Medical Incorporated |
| 2012-09-26 | Z-2381-2012 | Class II | The 2 | Integra Life Sci. |
| 2012-09-26 | Z-2382-2012 | Class II | Ultraview SL 91493 Integrated Module Housing | Spacelabs Healthcare, Llc |
| 2012-09-26 | Z-2383-2012 | Class II | Varian brand Clinac | Varian Medical Systems, Inc. Oncology Systems |
| 2012-09-26 | Z-2384-2012 | Class II | Philips DigitalDiagnost Systems with M Cabinet Model: 712025… | Philips Healthcare Inc. |
| 2012-09-26 | Z-2385-2012 | Class II | Sterile Distraction Screws of 3 different sizes: 12mm | Tedan Surgical Innovations Llc |
| 2012-09-26 | Z-2386-2012 | Class II | MX 16-slice CT Scanner System | Philips Medical Systems (Cleveland) Inc |
| 2012-09-26 | Z-2387-2012 | Class II | Instrumentation Laboratory ACL TOP | Instrumentation Laboratory Co. |
| 2012-09-26 | Z-2388-2012 | Class II | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a… | Instrumentation Laboratory Co. |
| 2012-09-26 | Z-2389-2012 | Class II | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a… | Instrumentation Laboratory Co. |
| 2012-09-26 | Z-2390-2012 | Class II | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a… | Instrumentation Laboratory Co. |
| 2012-09-26 | Z-2391-2012 | Class II | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a… | Instrumentation Laboratory Co. |
| 2012-09-26 | Z-2392-2012 | Class II | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a… | Instrumentation Laboratory Co. |
| 2012-09-26 | Z-2393-2012 | Class III | 0 | Amsino Medical USA |
| 2012-09-26 | Z-2394-2012 | Class III | 0 | Amsino Medical USA |
| 2012-09-26 | Z-2395-2012 | Class II | Empty Evacuated Container 250 mL and 1000 mL | Hospira Inc. |
| 2012-09-26 | Z-2396-2012 | Class II | Infinity¿ sampling device | US Endoscopy Group Inc |
| 2012-09-26 | Z-2397-2012 | Class II | BD FACS 7-color Setup beads BD Biosciences | BD Biosciences, Systems & Reagents |
| 2012-09-26 | Z-2398-2012 | Class II | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and… | Bio-Rad Laboratories |
| 2012-09-26 | Z-2399-2012 | Class II | JUGGERKNOT IN¿GUIDE PUNCH | Biomet, Inc. |
| 2012-09-26 | Z-2400-2012 | Class II | Guardian II Hemostasis Valve | Vascular Solutions, Inc. |
| 2012-09-26 | Z-2401-2012 | Class II | Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The… | ZOLL Medical Corporation |
| 2012-09-26 | Z-2402-2012 | Class II | A mobile | Steris Corporation |
| 2012-09-26 | Z-2403-2012 | Class II | Amplilink | Roche Molecular Systems, Inc. |
| 2012-09-26 | Z-2404-2012 | Class III | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a… | Philips Medical Systems (Cleveland) Inc |
| 2012-09-26 | Z-2405-2012 | Class II | Precise Digital Accelerator Delivery of radiation to defined target… | Elekta, Inc. |
| 2012-09-26 | Z-2409-2012 | Class III | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog… | Siemens Healthcare Diagnostics, Inc |
| 2012-09-26 | Z-2410-2012 | Class III | ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B… | Siemens Healthcare Diagnostics, Inc |
| 2012-09-26 | Z-2411-2012 | Class II | Octopus 101 Perimeter | Haag-Streit USA Inc |
| 2012-09-26 | Z-2412-2012 | Class II | Bard Ventralight ST Mesh | Davol, Inc., Subs. C. R. Bard, Inc. |
| 2012-09-26 | Z-2413-2012 | Class II | Bard Ventralight ST Mesh | Davol, Inc., Subs. C. R. Bard, Inc. |
| 2012-09-26 | Z-2414-2012 | Class II | S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed… | DePuy Orthopaedics, Inc. |
| 2012-09-26 | Z-2415-2012 | Class II | Kimberly-Clark MIC Safety PEG Kit | Kimberly-Clark Corporation |
| 2012-09-26 | Z-2416-2012 | Class II | Kimberly-Clark MIC PEG Kit | Kimberly-Clark Corporation |
| 2012-09-26 | Z-2417-2012 | Class II | Verify¿ Bowie-Dick Test Card | Steris Corporation |
| 2012-09-26 | Z-2418-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2419-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2420-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2421-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2422-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2423-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2424-2012 | Class II | Asahi KASEI | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| 2012-09-26 | Z-2425-2012 | Class III | ULTRA Fabric Reinforced Surgical Gown | Kimberly-Clark Corporation |
| 2012-09-26 | Z-2426-2012 | Class II | STERIS 5085 and 5085 SRT Surgical Tables | Steris Corporation |
| 2012-09-26 | Z-2427-2012 | Class II | 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14… | Smith & Nephew Inc |
| 2012-09-26 | Z-2428-2012 | Class II | Integra CRW Precision Arc | Integra LifeSciences Corporation |
| 2012-09-26 | Z-2429-2012 | Class II | Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW… | Integra LifeSciences Corporation |
| 2012-09-26 | Z-2430-2012 | Class III | Model 324JL On-Board Suction System Intended use: On-board suction… | Impact Instrumentation, Inc. |
| 2012-09-26 | Z-2431-2012 | Class II | Sekisui Spectrolyse PAI-1 | Sekisui Diagnostics Llc |
| 2012-09-19 | Z-2255-2012 | Class II | Optima XR220amx Mobile general purpose radiographic imaging of the… | GE Healthcare, LLC |
| 2012-09-19 | Z-2256-2012 | Class II | Optima XR200amx | GE Healthcare, LLC |
| 2012-09-19 | Z-2327-2012 | Class II | Bard Foley procedural trays packaged in breather bags | C.R. Bard, Inc., Urological Division |
| 2012-09-19 | Z-2328-2012 | Class II | CMS-8412-R2 Custom Cysto Pack containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-19 | Z-2329-2012 | Class II | CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV… | Custom Medical Specialties, Inc. |
| 2012-09-19 | Z-2330-2012 | Class II | CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep… | Custom Medical Specialties, Inc. |
| 2012-09-19 | Z-2331-2012 | Class II | CMS-2981-R3 Arthrogram Tray containing 2 oz | Custom Medical Specialties, Inc. |
| 2012-09-19 | Z-2332-2012 | Class II | Sunquest Laboratory Sunquest Laboratory is intended for use by… | Sunquest Information Systems, Inc. |
| 2012-09-19 | Z-2333-2012 | Class II | Aesculap S4 Element 4 | Aesculap Implant Systems LLC |
| 2012-09-19 | Z-2334-2012 | Class II | SUN|DASH RADIUS 252 tanning system | JK Products & Services, Inc |
| 2012-09-19 | Z-2335-2012 | Class II | The SYSTEM 1E Liquid Sterilant Processing System | Steris Corporation |
| 2012-09-19 | Z-2336-2012 | Class III | BLOM-SINGER indwelling TEP Occluder | Helix Medical LLC |
| 2012-09-19 | Z-2337-2012 | Class III | STERRAD 100S Cassette | Advanced Sterilization Products |
| 2012-09-19 | Z-2338-2012 | Class III | STERRAD NX Cassette | Advanced Sterilization Products |
| 2012-09-19 | Z-2339-2012 | Class II | Tip Cover for 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. |
| 2012-09-19 | Z-2340-2012 | Class II | Multileaf Collimator To be used for single or multiple fractions | Elekta, Inc. |
| 2012-09-19 | Z-2341-2012 | Class II | Siemens Uroskop Access | Siemens Medical Solutions USA, Inc |
| 2012-09-19 | Z-2342-2012 | Class II | Interfaces subject to recall: Medtronic NIM | Medtronic Xomed, Inc. |
| 2012-09-19 | Z-2343-2012 | Class II | Interfaces subject to recall: Medtronic NIM | Medtronic Xomed, Inc. |
| 2012-09-19 | Z-2344-2012 | Class II | Interfaces subject to recall: Medtronic NIM | Medtronic Xomed, Inc. |
| 2012-09-19 | Z-2345-2012 | Class II | Volcano brand Intravascular Ultrasound | Volcano Corporation |
| 2012-09-19 | Z-2346-2012 | Class II | Sterile Empty Vial and Injector | Hospira, Inc. |
| 2012-09-19 | Z-2347-2012 | Class II | Philips HeartStart MRx monitor/defibrillators Models: M3535A and… | Philips Healthcare Inc. |
| 2012-09-19 | Z-2348-2012 | Class II | Safety monitor included with System 8000 Base The Sarns" Modular… | Terumo Cardiovascular Systems Corporation |
| 2012-09-19 | Z-2361-2012 | Class II | REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm | Exactech, Inc. |
| 2012-09-19 | Z-2362-2012 | Class II | REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm | Exactech, Inc. |
| 2012-09-19 | Z-2363-2012 | Class II | REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm | Exactech, Inc. |
| 2012-09-19 | Z-2364-2012 | Class II | REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm | Exactech, Inc. |
| 2012-09-19 | Z-2365-2012 | Class II | REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm | Exactech, Inc. |
| 2012-09-19 | Z-2366-2012 | Class II | REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm | Exactech, Inc. |
| 2012-09-19 | Z-2367-2012 | Class II | Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray… | Siemens Medical Solutions USA, Inc |
| 2012-09-19 | Z-2368-2012 | Class II | Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is… | Lucero Medical LLC |
| 2012-09-19 | Z-2369-2012 | Class II | CARTO 3 V1 | Biosense Webster, Inc. |
| 2012-09-19 | Z-2370-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment | Omni Life Science |
| 2012-09-19 | Z-2371-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment | Omni Life Science |
| 2012-09-19 | Z-2372-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment | Omni Life Science |
| 2012-09-19 | Z-2373-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment | Omni Life Science |
| 2012-09-19 | Z-2374-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment | Omni Life Science |
| 2012-09-19 | Z-2375-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment | Omni Life Science |
| 2012-09-19 | Z-2376-2012 | Class II | GE Healthcare | GE Healthcare, LLC |
| 2012-09-19 | Z-2377-2012 | Class II | Capsule Neuron Docking Station | Capsule Tech Inc. |
| 2012-09-12 | Z-2250-2012 | Class I | Newport HT70 and HT70 Plus Ventilators | Newport Medical Instruments Inc |
| 2012-09-12 | Z-2260-2012 | Class I | V60 Ventilator | Respironics California Inc |
| 2012-09-12 | Z-2305-2012 | Class II | syngo | Siemens Healthcare Diagnostics, Inc. |
| 2012-09-12 | Z-2306-2012 | Class II | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies | Princeton Biomeditech Corp |
| 2012-09-12 | Z-2307-2012 | Class II | Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock… | Princeton Biomeditech Corp |
| 2012-09-12 | Z-2308-2012 | Class II | Status Flu A + B Test Manufactured by Princeton Bio Meditech… | Princeton Biomeditech Corp |
| 2012-09-12 | Z-2309-2012 | Class II | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is… | Cook Ireland Ltd. |
| 2012-09-12 | Z-2310-2012 | Class II | OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component… | Exactech, Inc. |
| 2012-09-12 | Z-2311-2012 | Class II | Acrobat 3000 | Trumpf Medical Systems, Inc. |
| 2012-09-12 | Z-2312-2012 | Class II | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe… | Capintec Inc |
| 2012-09-12 | Z-2313-2012 | Class II | Siemens ADVIA Centaur Multi-Diluent 1 | Siemens Healthcare Diagnostics, Inc |
| 2012-09-12 | Z-2314-2012 | Class II | TxRx Knee 15 Coil 3T | Quality Electrodynamics LLC |
| 2012-09-12 | Z-2315-2012 | Class II | Toshiba Ultra-Short Magnetic Resonance Imaging System | Toshiba American Medical Systems Inc |
| 2012-09-12 | Z-2316-2012 | Class II | BD GeneOhm MRSA ACP Assay Catalog #441637 | Becton Dickinson & Co. |
| 2012-09-12 | Z-2317-2012 | Class II | BD GeneOhm MRSA ACP Assay | Becton Dickinson & Co. |
| 2012-09-12 | Z-2318-2012 | Class II | BD GeneOhm Cdiff Assay | Becton Dickinson & Co. |
| 2012-09-12 | Z-2319-2012 | Class II | BD GeneOhm Cdiff Assay | Becton Dickinson & Co. |
| 2012-09-12 | Z-2320-2012 | Class II | BD GeneOhm VanR Assay | Becton Dickinson & Co. |
| 2012-09-12 | Z-2321-2012 | Class II | AmeriWater MRO Dialysis RO+ System | AmeriWater Inc |
| 2012-09-12 | Z-2322-2012 | Class II | Siemens Mobilett Mira | Siemens Medical Solutions USA, Inc |
| 2012-09-12 | Z-2323-2012 | Class III | VersaTREK Windows Software | Trek Diagnostic Systems |
| 2012-09-12 | Z-2324-2012 | Class II | Brand name: RayStation | RAYSEARCH LABORATORIES AB |
| 2012-09-12 | Z-2325-2012 | Class III | 100 ft roll of tubing inside a cardboard box | Steris Corporation |
| 2012-09-12 | Z-2326-2012 | Class II | Polar Dressing | Breg Inc, An Orthofix Company |
| 2012-09-05 | Z-2251-2012 | Class I | OEC IT3000 | GE OEC Medical Systems, Inc |
| 2012-09-05 | Z-2253-2012 | Class I | ON-Q pump with ONDEMAND bolus button | I-Flow Corporation |
| 2012-09-05 | Z-2263-2012 | Class II | Cisco brand HealthPresence | Cisco Systems Inc |
| 2012-09-05 | Z-2264-2012 | Class II | syngo Imaging XS | Siemens Medical Solutions USA, Inc |
| 2012-09-05 | Z-2265-2012 | Class II | Canon Solid State X-ray Imager | Canon Inc. |
| 2012-09-05 | Z-2266-2012 | Class II | Toshiba CT systems | Toshiba American Medical Systems Inc |
| 2012-09-05 | Z-2267-2012 | Class II | CaviCide | Metrex Research, LLC. |
| 2012-09-05 | Z-2268-2012 | Class III | Mini-Infuser Model 150XL Single Speed Infusion Pump | Baxter Healthcare Corp. |
| 2012-09-05 | Z-2269-2012 | Class III | Mini-Infuser Model 300XL Multispeed Infusion Pump | Baxter Healthcare Corp. |