| Reported | Recall | Class | Product | Firm |
|---|
| 2012-12-26 | Z-0494-2013 | Class II | GE Healthcare | GE Healthcare, LLC |
| 2012-12-26 | Z-0514-2013 | Class I | Patient Circuit used with the Life Pulse High Frequency Ventilator | Bunnell, Inc. |
| 2012-12-26 | Z-0524-2013 | Class II | GE Healthcare Carescape Patient Data Module with v2 | GE Healthcare, LLC |
| 2012-12-26 | Z-0526-2013 | Class II | EEG NeuroAmp | EEG Info |
| 2012-12-26 | Z-0527-2013 | Class II | EBI XFIX DFS Rail System | Biomet, Inc. |
| 2012-12-26 | Z-0528-2013 | Class II | Mindray V12 Size: 320 mm X 320 mm X 450 mm N | Mindray DS USA, Inc. d.b.a. Mindray North America |
| 2012-12-26 | Z-0529-2013 | Class II | DePuy Mitek 11 MM Fully Fluted Reamer | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| 2012-12-26 | Z-0531-2013 | Class II | Varian brand ARIA Radiation Oncology | Varian Medical Systems, Inc. Oncology Systems |
| 2012-12-26 | Z-0532-2013 | Class II | Medline Total Knee CDS | Medline Industries Inc |
| 2012-12-26 | Z-0533-2013 | Class II | Biomet Offset Tibial Tray 2 | Biomet, Inc. |
| 2012-12-26 | Z-0534-2013 | Class II | Arobella Medical 6mm Qurette used with the Arobella Medical AR1000… | Arobella Medical, LLC |
| 2012-12-26 | Z-0535-2013 | Class II | Titan Spine Endoskeleton TA Implant products | TITAN SPINE, LLC |
| 2012-12-26 | Z-0536-2013 | Class II | Biomet Polaris 5 | Ebi, Llc |
| 2012-12-26 | Z-0537-2013 | Class II | COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS &… | Zimmer, Inc. |
| 2012-12-26 | Z-0538-2013 | Class II | Coonrad/Morrey New Ulnar Revision Kit for Use with… | Zimmer, Inc. |
| 2012-12-26 | Z-0539-2013 | Class II | Persona The Personalized Knee System | Zimmer, Inc. |
| 2012-12-26 | Z-0540-2013 | Class II | Persona The Personalized Knee System | Zimmer, Inc. |
| 2012-12-26 | Z-0541-2013 | Class II | Persona The Personalized Knee System | Zimmer, Inc. |
| 2012-12-26 | Z-0542-2013 | Class II | Persona The Personalized Knee System | Zimmer, Inc. |
| 2012-12-26 | Z-0543-2013 | Class II | Persona The Personalized Knee System | Zimmer, Inc. |
| 2012-12-26 | Z-0544-2013 | Class II | Persona The Personalized Knee System | Zimmer, Inc. |
| 2012-12-26 | Z-0545-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0546-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0547-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0548-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0549-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0550-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0551-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0552-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0553-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0554-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0555-2013 | Class II | Persona | Zimmer, Inc. |
| 2012-12-26 | Z-0556-2013 | Class II | Invacare Height Adjustable | Invacare Corporation |
| 2012-12-26 | Z-0557-2013 | Class II | ThyssenKrupp Accessibility LEVANT Stairlift | ThyssenKrupp Access Corp |
| 2012-12-26 | Z-0558-2013 | Class II | MAYFIELD Composite Series Base Unit | Integra LifeSciences Corporation |
| 2012-12-26 | Z-0559-2013 | Class II | MAYFIELD Composite Series Skull Clamps | Integra LifeSciences Corporation |
| 2012-12-26 | Z-0560-2013 | Class II | Advantage Workstation Volume Share 2 | GE Healthcare, LLC |
| 2012-12-26 | Z-0561-2013 | Class II | AutoTac Delivery Handle | BioHorizons Implant Systems Inc |
| 2012-12-26 | Z-0562-2013 | Class II | Titanium Tack Starter Kit | BioHorizons Implant Systems Inc |
| 2012-12-26 | Z-0563-2013 | Class II | CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory… | Dako Denmark A/S |
| 2012-12-26 | Z-0564-2013 | Class II | Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD | Becton Dickinson & Company |
| 2012-12-26 | Z-0565-2013 | Class II | BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are… | Del Mar Reynolds Medical, Ltd. |
| 2012-12-26 | Z-0566-2013 | Class II | The Stryker Model 6390 | Stryker Medical Division of Stryker Corporation |
| 2012-12-26 | Z-0567-2013 | Class II | Medtronic | Medtronic Neuromodulation |
| 2012-12-26 | Z-0568-2013 | Class II | Medline Angio Drape Pack Radiology-LF | Medline Industries Inc |
| 2012-12-26 | Z-0569-2013 | Class II | Pinnacle Cancellous Screw Packaging: Product is housed within a… | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0570-2013 | Class II | BD Phoenix PMIC-108 Panels | Becton Dickinson & Co. |
| 2012-12-26 | Z-0571-2013 | Class II | SpineSix consists of a motorized treatment table that is controlled… | BioMotion Medical Systems, LLC |
| 2012-12-26 | Z-0572-2013 | Class II | The Access hLH assay is a paramagnetic particle | Beckman Coulter Inc. |
| 2012-12-26 | Z-0573-2013 | Class II | SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly… | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0574-2013 | Class II | SOL SYS F 8 CALC 13 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0575-2013 | Class II | SOL SYS 8IN CALC 1 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0576-2013 | Class II | SOL SYS 8IN CALC 1 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0577-2013 | Class II | SOL SYS 8IN CALC 1 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0578-2013 | Class II | SOL SYS 8IN CALC 1 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0579-2013 | Class II | SOL SYS F 9 CALC L 13 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0580-2013 | Class II | SOL SYS L 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0581-2013 | Class II | SOL SYS L 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0582-2013 | Class II | SOL SYS L 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0583-2013 | Class II | SOL SYS L 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0584-2013 | Class II | SOL SYS L 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0585-2013 | Class II | SOL SYS L 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0586-2013 | Class II | SOL SYS F 9 CALC L 13 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0587-2013 | Class II | SOL SYS R 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0588-2013 | Class II | SOL SYS R 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0589-2013 | Class II | SOL SYS R 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0590-2013 | Class II | SOL SYS R 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0591-2013 | Class II | SOL SYS R 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0592-2013 | Class II | SOL SYS R 9IN CALC 2 | DePuy Orthopaedics, Inc. |
| 2012-12-26 | Z-0593-2013 | Class II | Bausch + Lomb Stellaris PC Vision Enhancement System | Bausch & Lomb Inc |
| 2012-12-26 | Z-0595-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0596-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0597-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0598-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0599-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0600-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0601-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0602-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0603-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0604-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0605-2013 | Class II | Medrad | Medrad Inc |
| 2012-12-26 | Z-0607-2013 | Class II | Segmented Cervix Applicator Set | Varian Medical Systems, Inc. |
| 2012-12-19 | Z-0478-2013 | Class I | The GlideScope Video Laryngoscope | Verathon, Inc. |
| 2012-12-19 | Z-0481-2013 | Class II | Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that… | Hospira Inc. |
| 2012-12-19 | Z-0482-2013 | Class II | Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet… | Hospira Inc. |
| 2012-12-19 | Z-0483-2013 | Class II | Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software… | Hospira Inc. |
| 2012-12-19 | Z-0484-2013 | Class II | Data Station AMPLILINK software is an instrument user interface/ data… | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0485-2013 | Class II | The MagNA Pure LC | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0486-2013 | Class II | The MagNA Pure 96 System | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0487-2013 | Class II | LightCycler 1 | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0488-2013 | Class II | LightCycler 2 | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0489-2013 | Class II | The COBAS 8000 data manager modular analyzer series | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0490-2013 | Class II | The COBAS INTEGRA 400/400 plus system | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0491-2013 | Class II | DataInnovations | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0492-2013 | Class II | DataCara GM is an information management system that provides data… | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0493-2013 | Class II | DataCare POC is an information management system that provides data… | Roche Molecular Systems, Inc. |
| 2012-12-19 | Z-0495-2013 | Class II | Philips IntelliVue Information Center/Client and Philips IntelliVue… | Philips Healthcare Inc. |
| 2012-12-19 | Z-0496-2013 | Class I | SynchroMed EL | Medtronic Neuromodulation |
| 2012-12-19 | Z-0497-2013 | Class I | Medtronic SynchroMed II | Medtronic Neuromodulation |
| 2012-12-19 | Z-0498-2013 | Class II | Reusable | Covidien LLC dba Uni-Patch |
| 2012-12-19 | Z-0499-2013 | Class II | Reusable | Covidien LLC dba Uni-Patch |
| 2012-12-19 | Z-0500-2013 | Class II | Performa reusable and self-adhering TENS/NMES/FES stimulating… | Covidien LLC dba Uni-Patch |
| 2012-12-19 | Z-0501-2013 | Class II | Empi STIMC RE Self Adhesive electrodes | Covidien LLC dba Uni-Patch |
| 2012-12-19 | Z-0502-2013 | Class II | WANG Transbronchial Aspiration Needles Cat | ConMed Corporation |
| 2012-12-19 | Z-0503-2013 | Class II | WANG Transbronchial Aspiration Needles Cat | ConMed Corporation |
| 2012-12-19 | Z-0504-2013 | Class II | WANG Transbronchial Aspiration Needles Cat | ConMed Corporation |
| 2012-12-19 | Z-0505-2013 | Class II | WANG Transbronchial Aspiration Needles Cat | ConMed Corporation |
| 2012-12-19 | Z-0506-2013 | Class II | Siemens Healthcare BNP | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0507-2013 | Class II | Siemens Healthcare BR Assay for CA 27 | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0508-2013 | Class II | Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test… | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0509-2013 | Class II | Siemens Healthcare ADVIA Centaur DHEA-504 | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0510-2013 | Class II | Siemens Healthcare ADVIA Centaur Digitoxin | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0511-2013 | Class II | Siemens Healthcare ADVIA Centaur Folate | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0512-2013 | Class II | Siemens Healthcare ADVIA Centaur Theophylline 2 | Siemens Healthcare Diagnostics, Inc |
| 2012-12-19 | Z-0513-2013 | Class II | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA | Mindray DS USA, Inc. d.b.a. Mindray North America |
| 2012-12-19 | Z-0515-2013 | Class II | MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX… | Siemens Medical Solutions USA, Inc |
| 2012-12-19 | Z-0517-2013 | Class II | Baby Quasar | Quasar Bio-Tech, Inc. dba Silver Bay LLC |
| 2012-12-19 | Z-0518-2013 | Class II | Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR… | Quasar Bio-Tech, Inc. dba Silver Bay LLC |
| 2012-12-19 | Z-0519-2013 | Class II | Quasar Power Pack contains a Baby Quasar and a Baby Blue | Quasar Bio-Tech, Inc. dba Silver Bay LLC |
| 2012-12-19 | Z-0520-2013 | Class II | STERRAD CYCLESURE 24 Biological Indicator | Advanced Sterilization Products |
| 2012-12-19 | Z-0521-2013 | Class II | Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal… | Leica Microsystems, Inc. |
| 2012-12-19 | Z-0522-2013 | Class II | Cobas b 123 POC system cobas b 123 POC system is fully automated POC… | Roche Diagnostics Operations, Inc. |
| 2012-12-19 | Z-0523-2013 | Class II | BD BBL Taxo XV Factor Strips | Becton Dickinson & Co. |
| 2012-12-12 | Z-0447-2013 | Class I | The product has the Catalogue/Part number 60010 | Natus Medical Incorporated |
| 2012-12-12 | Z-0452-2013 | Class II | Dimension Vista | Siemens Healthcare Diagnostics, Inc. |
| 2012-12-12 | Z-0453-2013 | Class II | OmniGuide BP-ROBOTIC | OmniGuide, Inc. |
| 2012-12-12 | Z-0454-2013 | Class II | Neptune¿ 2 Rover | Stryker Instruments Div. of Stryker Corporation |
| 2012-12-12 | Z-0455-2013 | Class II | Neptune¿ 2 Rover | Stryker Instruments Div. of Stryker Corporation |
| 2012-12-12 | Z-0456-2013 | Class II | 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0457-2013 | Class II | 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0458-2013 | Class II | 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0459-2013 | Class II | 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0460-2013 | Class II | 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0461-2013 | Class II | 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0462-2013 | Class II | 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for… | Terumo Cardiovascular Systems Corporation |
| 2012-12-12 | Z-0463-2013 | Class II | Sekisui Diagnostics | Sekisui Diagnostics Llc |
| 2012-12-12 | Z-0464-2013 | Class II | Custom Procedural Trays: Merit's Custom Total Hip Pack | Merit Medical Systems, Inc. |
| 2012-12-12 | Z-0465-2013 | Class II | Siemens syngo | Siemens Medical Solutions USA, Inc |
| 2012-12-12 | Z-0466-2013 | Class II | NeuViz 16 Multi-Sliced CT Scanner System | Philips And Neusoft Medical Systems Co., Ltd. |
| 2012-12-12 | Z-0467-2013 | Class II | BiOM Rechargeable Li Ion 22 | iwalk inc |
| 2012-12-12 | Z-0468-2013 | Class II | Invivo Corporation Expression MRI Patient Monitoring System | Invivo Corporation |
| 2012-12-12 | Z-0469-2013 | Class II | Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION… | Stryker Howmedica Osteonics Corp. |
| 2012-12-12 | Z-0470-2013 | Class II | Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION… | Stryker Howmedica Osteonics Corp. |
| 2012-12-12 | Z-0471-2013 | Class II | OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8 | Biomet, Inc. |
| 2012-12-12 | Z-0472-2013 | Class II | OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13 | Biomet, Inc. |
| 2012-12-12 | Z-0473-2013 | Class II | Cobas 8000 Modular Analyzer Series | Roche Diagnostics Operations, Inc. |
| 2012-12-12 | Z-0474-2013 | Class II | Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted | Biomet, Inc. |
| 2012-12-12 | Z-0475-2013 | Class II | Philips Digital Diagnost Software Version R2 | Philips Healthcare Inc. |
| 2012-12-12 | Z-0480-2013 | Class II | Siemens Mobilette Mira | Siemens Medical Solutions USA, Inc |
| 2012-12-05 | Z-0161-2013 | Class I | Medpro Elastomeric Infusion Pump | First Medical Source LLC |
| 2012-12-05 | Z-0435-2013 | Class II | 100/120V AC | Terumo Cardiovascular Systems Corporation |
| 2012-12-05 | Z-0436-2013 | Class II | 220/240V AC | Terumo Cardiovascular Systems Corporation |
| 2012-12-05 | Z-0437-2013 | Class II | NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component… | Zimmer, Inc. |
| 2012-12-05 | Z-0438-2013 | Class II | IO FiX X-Post Reamer | Extremity Medical LLC |
| 2012-12-05 | Z-0439-2013 | Class II | Cooper Surgical RUMI Arch | Cooper Surgical, Inc. |
| 2012-12-05 | Z-0440-2013 | Class II | Cooper Surgical Advincula Arch | Cooper Surgical, Inc. |
| 2012-12-05 | Z-0441-2013 | Class II | The Vertex Max Drill Tube is a component within the Navigated Vertex… | Medtronic Navigation, Inc. |
| 2012-12-05 | Z-0442-2013 | Class II | Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless… | Biomet, Inc. |
| 2012-12-05 | Z-0443-2013 | Class II | Devices includes a Multi Port Inflator or without Multi Port Inflator | Parks Medical Electronics, Inc |
| 2012-12-05 | Z-0444-2013 | Class II | Pentron Clinical Metrex Research | Metrex Research, LLC. |
| 2012-12-05 | Z-0445-2013 | Class II | The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The… | Diamedix Corporation |
| 2012-12-05 | Z-0446-2013 | Class II | The brand name is MRidium Series 1000 MR Infusion Sets | Iradimed Corporation |
| 2012-12-05 | Z-0448-2013 | Class II | GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE… | GE Healthcare, LLC |
| 2012-12-05 | Z-0449-2013 | Class II | GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE… | GE Healthcare, LLC |
| 2012-12-05 | Z-0450-2013 | Class II | GE Healthcare Optima XR 200 amx with Digital Upgrade | GE Healthcare, LLC |
| 2012-12-05 | Z-0451-2013 | Class II | Kimberly-Clark Patient Warming System | Kimberly-Clark Corporation |
| 2012-11-28 | Z-0197-2013 | Class II | GE Healthcare Optima XR 200amx with digital upgrade Mobile general… | GE Healthcare, LLC |
| 2012-11-28 | Z-0198-2013 | Class II | GE Healthcare Optima XR 220amx Mobile general purpose radiographic… | GE Healthcare, LLC |
| 2012-11-28 | Z-0199-2013 | Class II | GE Healthcare Optima 200amx Mobile general purpose radiographic… | GE Healthcare, LLC |
| 2012-11-28 | Z-0200-2013 | Class II | GE Healthcare Brivo XR 285 Mobile general purpose radiographic… | GE Healthcare, LLC |
| 2012-11-28 | Z-0290-2013 | Class I | Mindray A3 Anesthesia Delivery System Manufactured in China for… | Mindray DS USA, Inc. d.b.a. Mindray North America |
| 2012-11-28 | Z-0291-2013 | Class I | Mindray A5 Anesthesia Delivery System Manufactured in China for… | Mindray DS USA, Inc. d.b.a. Mindray North America |
| 2012-11-28 | Z-0292-2013 | Class I | ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin… | Ethicon, Inc. |
| 2012-11-28 | Z-0293-2013 | Class I | ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON | Ethicon, Inc. |
| 2012-11-28 | Z-0297-2013 | Class II | Product is Full OSSEOTITE 2 Tapered Certain Implant | Biomet 3i, LLC |
| 2012-11-28 | Z-0298-2013 | Class II | Product is Full OSSEOTITE Parallel Walled Certain Implant | Biomet 3i, LLC |
| 2012-11-28 | Z-0299-2013 | Class II | bioMerieux BacT/ALERT Control Module | Biomerieux Inc |
| 2012-11-28 | Z-0300-2013 | Class II | bioMerieux BacT/ALERT Combo Module | Biomerieux Inc |
| 2012-11-28 | Z-0301-2013 | Class II | bioMerieux BacT/ALERT 3D 60 | Biomerieux Inc |
| 2012-11-28 | Z-0302-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0303-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0304-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0305-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0306-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0307-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0308-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0309-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0310-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0311-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0312-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0313-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0314-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0315-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0316-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0317-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0318-2013 | Class II | bioMerieux BacT/ALERT Control Module | Biomerieux Inc |
| 2012-11-28 | Z-0319-2013 | Class II | bioMerieux BacT/ALERT Combo Module | Biomerieux Inc |
| 2012-11-28 | Z-0320-2013 | Class II | bioMerieux BacT/ALERT Combo Module | Biomerieux Inc |
| 2012-11-28 | Z-0321-2013 | Class II | bioMerieux Kit | Biomerieux Inc |
| 2012-11-28 | Z-0322-2013 | Class II | bioMerieux Kit | Biomerieux Inc |