Medical device recalls reported in 2012

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Reported	Recall	Class	Product	Firm
2012-11-14	Z-0264-2013	Class II	0	Shimadzu Medical Systems
2012-11-14	Z-0265-2013	Class II	0	Shimadzu Medical Systems
2012-11-14	Z-0266-2013	Class II	Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545…	Stryker Howmedica Osteonics Corp.
2012-11-14	Z-0267-2013	Class II	Quadra S Offset Broach Handle The offset broach handle is intended to…	Medacta Usa Inc
2012-11-14	Z-0268-2013	Class II	The brand name of the device is AlgiNot	Kerr Corporation
2012-11-14	Z-0269-2013	Class II	TI Standard Polyaxial Screw Assembly 6	Alphatec Spine, Inc.
2012-11-14	Z-0270-2013	Class II	AC Powered adjustable hospital bed	Primus Medical LLC
2012-11-14	Z-0271-2013	Class II	S5 Single Roller Pump 150	Sorin Group USA, Inc.
2012-11-14	Z-0272-2013	Class II	S5 Double Roller Pump 85	Sorin Group USA, Inc.
2012-11-14	Z-0273-2013	Class II	S5 Mast Roller Pump 85	Sorin Group USA, Inc.
2012-11-14	Z-0274-2013	Class II	S5 Mast Roller Pump 150	Sorin Group USA, Inc.
2012-11-14	Z-0275-2013	Class II	Sorin C5 Perfusion System	Sorin Group USA, Inc.
2012-11-07	Z-0124-2013	Class I	HeartSine Samaritan	Heartsine Technologies, Limited
2012-11-07	Z-0159-2013	Class II	Progressive Medical PMI Endoscopic Dissector with Kittner Tip	Progressive Medical Inc
2012-11-07	Z-0160-2013	Class II	QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator	Maquet Cardiovascular Us Sales, Llc
2012-11-07	Z-0162-2013	Class II	Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937	Siemens Healthcare Diagnostics, Inc
2012-11-07	Z-0163-2013	Class II	Aviator Drill Bit	Stryker Spine
2012-11-07	Z-0164-2013	Class II	"*All in one CrossFTPunchPFT-00M*4	Linvatec Corp. dba ConMed Linvatec
2012-11-07	Z-0165-2013	Class II	Myocardial Heart Wires Intended for temporary atrial and ventricular…	Oscor, Inc.
2012-11-07	Z-0166-2013	Class II	SCP Pump Control Panel	Sorin Group USA, Inc.
2012-11-07	Z-0167-2013	Class II	SCP Pump Control Panel	Sorin Group USA, Inc.
2012-11-07	Z-0168-2013	Class II	ILLlCO¿ MIS Posterior Fixation System	Alphatec Spine, Inc.
2012-11-07	Z-0169-2013	Class II	MOSAIQ MOSAIQ is an image-enabled electronic medical record system	Elekta, Inc.
2012-11-07	Z-0170-2013	Class I	Safe Spot Infant Resuscitator	Ventlab Corporation
2012-11-07	Z-0171-2013	Class I	Adult Resuscitator	Ventlab Corporation
2012-11-07	Z-0172-2013	Class I	Stat-Check Resuscitator	Ventlab Corporation
2012-11-07	Z-0173-2013	Class I	V*Care Resuscitator Infant Resuscitator	Ventlab Corporation
2012-11-07	Z-0174-2013	Class I	Breath Tech	Ventlab Corporation
2012-11-07	Z-0175-2013	Class I	AirFlow Resuscitator	Ventlab Corporation
2012-11-07	Z-0176-2013	Class I	Safe Spot Infant Resuscitator	Ventlab Corporation
2012-11-07	Z-0177-2013	Class I	Ventlab Premium Small Child Resuscitator	Ventlab Corporation
2012-11-07	Z-0178-2013	Class I	Ventlab Premium Small Adult Resuscitator	Ventlab Corporation
2012-11-07	Z-0179-2013	Class I	Ventlab Rescue Med Infant Resuscitator	Ventlab Corporation
2012-11-07	Z-0180-2013	Class I	AirFlow	Ventlab Corporation
2012-11-07	Z-0181-2013	Class I	AirFlow	Ventlab Corporation
2012-11-07	Z-0182-2013	Class III	West Nile Virus IgG DxSelect" kit Catalog No	Focus Diagnostics Inc
2012-11-07	Z-0183-2013	Class II	Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28	Wright Medical Technology Inc
2012-11-07	Z-0184-2013	Class II	Knee Components: ROTULE "913" D=32	Wright Medical Technology Inc
2012-11-07	Z-0185-2013	Class II	Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM	Wright Medical Technology Inc
2012-11-07	Z-0186-2013	Class II	Software for Vitrea	Vital Images, Inc.
2012-11-07	Z-0187-2013	Class II	ARIA Radiation Oncology	Varian Medical Systems, Inc. Oncology Systems
2012-11-07	Z-0188-2013	Class III	cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche…	Roche Molecular Systems, Inc.
2012-10-31	Z-0024-2013	Class II	Reference materials "RETINAL OCT Analysis and Interpretation Method"…	Optovue Inc.
2012-10-31	Z-0069-2013	Class I	Symbiq One Channel Infuser	Hospira Inc.
2012-10-31	Z-0070-2013	Class I	Symbiq Two Channel Infuser	Hospira Inc.
2012-10-31	Z-0095-2013	Class II	GE Seno Advantage 1	GE Healthcare, LLC
2012-10-31	Z-0096-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0097-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0098-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0099-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0100-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0101-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0102-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0103-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0104-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0105-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0106-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0107-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0108-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0109-2013	Class II	Pulset Arterial Blood Gas	Westmed Inc
2012-10-31	Z-0110-2013	Class III	Synchron Systems Synchron Calibrator Multi Calibrator Diskettes	Beckman Coulter Inc.
2012-10-31	Z-0111-2013	Class II	EVICEL Fibrin Sealant	Ethicon, Inc.
2012-10-31	Z-0112-2013	Class II	AdvanDx GNR Traffic Light PNA FISH	Advandx Inc
2012-10-31	Z-0113-2013	Class II	GE Healthcare innova 3100	GE Healthcare, LLC
2012-10-31	Z-0114-2013	Class II	GE Healthcare innova 3100-IQ	GE Healthcare, LLC
2012-10-31	Z-0115-2013	Class II	GE Healthcare innova 3131-IQ Mobile X-ray system	GE Healthcare, LLC
2012-10-31	Z-0116-2013	Class II	AdvanDx E	Advandx Inc
2012-10-31	Z-0117-2013	Class II	HiRes 90K devices with Helix Electrodes Model CI 1400-02H The…	Advanced Bionics Corporation
2012-10-31	Z-0118-2013	Class II	Oncentra External Beam 4	Elekta, Inc.
2012-10-31	Z-0119-2013	Class II	Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i…	Biomet 3i, LLC
2012-10-31	Z-0120-2013	Class III	The brand name of the device is Damon 3MX Bicuspid Bracket	Ormco/Sybronendo
2012-10-31	Z-0121-2013	Class II	GE Discovery NM/CT670	GE Healthcare, LLC
2012-10-31	Z-0122-2013	Class II	"**ORTHO SENSOR12-123-A Knee Trial for Trithion***1560 Saw grass…	Orthosensor
2012-10-31	Z-0123-2013	Class II	UniCel¿ DxC 600/800 with Software v5	Beckman Coulter Inc.
2012-10-31	Z-0125-2013	Class II	GE Healthcare	GE Healthcare, LLC
2012-10-31	Z-0126-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-10-31	Z-0127-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-10-31	Z-0128-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-10-31	Z-0129-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-10-31	Z-0130-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-10-31	Z-0131-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-10-31	Z-0132-2013	Class II	Biosense Webster MobiCath Bi-Directional Guiding Sheath	Greatbatch Medical
2012-10-31	Z-0133-2013	Class II	DePuy Mitek VAPR Hook Electrode 3	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0134-2013	Class II	AquaLiner Hydrophilic Guidewire 0	Nipro Medical Corporation
2012-10-31	Z-0135-2013	Class II	AquaLiner Hydrophilic Guidewire 0	Nipro Medical Corporation
2012-10-31	Z-0136-2013	Class II	AquaLiner Hydrophilic Guidewire 0	Nipro Medical Corporation
2012-10-31	Z-0137-2013	Class II	AquaLiner Hydrophilic Guidewire 0	Nipro Medical Corporation
2012-10-31	Z-0138-2013	Class II	AquaLiner Hydrophilic Guidewire 0	Nipro Medical Corporation
2012-10-31	Z-0139-2013	Class II	6	Encore Medical, Lp
2012-10-31	Z-0140-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0141-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0142-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0143-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0144-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0145-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0146-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0147-2013	Class II	Screw	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0148-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0149-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0150-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0151-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0152-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0153-2013	Class II	SpiraLok 5	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0154-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0155-2013	Class II	SpiraLok 6	DePuy Mitek, Inc., a Johnson & Johnson Co.
2012-10-31	Z-0156-2013	Class II	Repeater Pump	Baxa Corporation
2012-10-31	Z-0157-2013	Class II	Gish 3/8 x 3/8" Straight Connector with Luer fitting	Sorin Group USA, Inc.
2012-10-31	Z-0158-2013	Class II	Gish 3/8 x 1/2" Reducer Connector with Luer fitting	Sorin Group USA, Inc.
2012-10-24	Z-0056-2013	Class II	AutoMate 1250 and AutoMate 2550	Beckman Coulter Inc.
2012-10-24	Z-0057-2013	Class I	Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The…	Ethicon Endo-Surgery Inc
2012-10-24	Z-0058-2013	Class II	Belmont Rapid Infuser	Belmont Instrument Corporation
2012-10-24	Z-0059-2013	Class II	Unicel Closed Tube Aliquotter	Beckman Coulter Inc.
2012-10-24	Z-0060-2013	Class II	CPT Modular Stem	Zimmer, Inc.
2012-10-24	Z-0061-2013	Class II	CPT Hip System Femoral Stem Petite	Zimmer, Inc.
2012-10-24	Z-0062-2013	Class II	CPT Femoral Stem 12/14 Neck Taper Extended Offset	Zimmer, Inc.
2012-10-24	Z-0063-2013	Class II	"*PressFT*2	Linvatec Corp. dba ConMed Linvatec
2012-10-24	Z-0064-2013	Class II	"*PressFT*2	Linvatec Corp. dba ConMed Linvatec
2012-10-24	Z-0065-2013	Class II	"*Press FT*2	Linvatec Corp. dba ConMed Linvatec
2012-10-24	Z-0066-2013	Class II	"*PressFT*2	Linvatec Corp. dba ConMed Linvatec
2012-10-24	Z-0067-2013	Class II	"*PressFT*2	Linvatec Corp. dba ConMed Linvatec
2012-10-24	Z-0068-2013	Class II	NP211H*2009-02*CONMED LINVATEC 11311 CONCEPT BLVD LARGO	Linvatec Corp. dba ConMed Linvatec
2012-10-24	Z-0071-2013	Class II	Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous…	Terumo Cardiovascular Systems Corporation
2012-10-24	Z-0072-2013	Class II	***This recall is being conducted due to an incomplete recall for RES…	MOOG Medical Devices Group
2012-10-24	Z-0073-2013	Class III	Sunquest Laboratory : intended for use by professionals working in a…	Sunquest Information Systems, Inc.
2012-10-24	Z-0074-2013	Class II	"*Electric Systems Foot ControlRx Only*" Product Usage:…	The Anspach Effort, Inc.
2012-10-24	Z-0075-2013	Class II	"*Electric Systems Foot Control with Direction OnlyRx Only**"…	The Anspach Effort, Inc.
2012-10-24	Z-0076-2013	Class II	"*Electric Systems Foot Control with Direction and Irrigation*Rx…	The Anspach Effort, Inc.
2012-10-24	Z-0077-2013	Class II	Helion and Xenion surgical lights	Trumpf Medical Systems, Inc.
2012-10-24	Z-0078-2013	Class II	Hem-o-lok Large Polymer Ligating Clips	Teleflex Medical
2012-10-24	Z-0079-2013	Class II	LeVeen Standard Needle Electrode System	Boston Scientific Corporation
2012-10-24	Z-0080-2013	Class II	Leveen Coaccess Needle Electrode	Boston Scientific Corporation
2012-10-24	Z-0081-2013	Class II	Leveen Coaccess Introducer Set	Boston Scientific Corporation
2012-10-24	Z-0082-2013	Class II	Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument	Aesculap, Inc.
2012-10-24	Z-0083-2013	Class II	Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft…	Osteotech Inc
2012-10-24	Z-0084-2013	Class II	Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft…	Osteotech Inc
2012-10-24	Z-0085-2013	Class II	Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft…	Osteotech Inc
2012-10-24	Z-0086-2013	Class II	Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft…	Osteotech Inc
2012-10-24	Z-0087-2013	Class II	Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft…	Osteotech Inc
2012-10-24	Z-0088-2013	Class II	Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone…	Osteotech Inc
2012-10-24	Z-0089-2013	Class II	Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone…	Osteotech Inc
2012-10-24	Z-0090-2013	Class II	Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human…	Osteotech Inc
2012-10-24	Z-0091-2013	Class II	Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human…	Osteotech Inc
2012-10-24	Z-0092-2013	Class II	Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human…	Osteotech Inc
2012-10-24	Z-0093-2013	Class II	Optimum Expanse R Grafton is a human bone allograft product…	Osteotech Inc
2012-10-24	Z-0094-2013	Class II	Optimum Expanse S Multiple sizes Grafton is a human bone allograft…	Osteotech Inc
2012-10-17	Z-0012-2013	Class I	Baxter Interlink System Buretrol Solution Set with 150 mL Burette	Baxter Healthcare Corp.
2012-10-17	Z-0013-2013	Class I	Baxter Interlink System Buretrol Solution Set	Baxter Healthcare Corp.
2012-10-17	Z-0014-2013	Class I	Baxter Clearlink System Buretrol Solution Set	Baxter Healthcare Corp.
2012-10-17	Z-0015-2013	Class I	Baxter Clearlink System Buretrol Solution Set	Baxter Healthcare Corp.
2012-10-17	Z-0016-2013	Class II	Active Renin IRMA Kit	Beckman Coulter Inc.
2012-10-17	Z-0017-2013	Class I	Flow Meter	Accutron Inc
2012-10-17	Z-0018-2013	Class I	Ultra PC% Cabinet Mount Package G	Accutron Inc
2012-10-17	Z-0019-2013	Class I	CM Flowmeter Pkg H	Accutron Inc
2012-10-17	Z-0020-2013	Class I	Newport Portable Package	Accutron Inc
2012-10-17	Z-0021-2013	Class II	Unicel DxH 800 Coulter Cellular Analysis System	Beckman Coulter Inc.
2012-10-17	Z-0022-2013	Class II	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL	3M Company - Health Care Business
2012-10-17	Z-0023-2013	Class II	PREVI Isola System	Biomerieux Inc
2012-10-17	Z-0025-2013	Class II	The Eon Mini Implantable Pulse Generator	Advanced Neuromodulation Systems Inc.
2012-10-17	Z-0026-2013	Class II	OrthoHelix Part #HCS-056-32 3	Orthohelix Surgical Designs Inc
2012-10-17	Z-0027-2013	Class II	OrthoHelix Part #HCS-056-32 3	Orthohelix Surgical Designs Inc
2012-10-17	Z-0028-2013	Class II	Automatic Cutting Needles	Remington Medical Inc.
2012-10-17	Z-0029-2013	Class II	Triage TOX Drug Screen Panel	Alere San Diego, Inc.
2012-10-17	Z-0030-2013	Class II	Emit	Siemens Healthcare Diagnostics, Inc.
2012-10-17	Z-0031-2013	Class II	Caremor Cliner"*Manufactured By Winco*Ocala	Winco Mfg., LLC
2012-10-17	Z-0032-2013	Class II	Caremor Cliner is labeled in part: "*Manufactured By Winco*Ocala	Winco Mfg., LLC
2012-10-17	Z-0033-2013	Class II	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5	Beckman Coulter Inc.
2012-10-17	Z-0034-2013	Class II	CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5	Beckman Coulter Inc.
2012-10-17	Z-0035-2013	Class II	TetraCXP Software System	Beckman Coulter Inc.
2012-10-17	Z-0036-2013	Class II	ATLANTIS	Medtronic Sofamor Danek USA Inc
2012-10-17	Z-0037-2013	Class II	ATLANTIS	Medtronic Sofamor Danek USA Inc
2012-10-17	Z-0038-2013	Class II	PREMIER	Medtronic Sofamor Danek USA Inc
2012-10-17	Z-0039-2013	Class II	IDS Urine BETA CrossLaps ELISA	Immunodiagnostics Systems Ltd
2012-10-17	Z-0040-2013	Class II	IDS-iSYS Ostase¿ BAP	Immunodiagnostics Systems Ltd
2012-10-17	Z-0041-2013	Class II	IDS-iSYS Ostase¿ BAP	Immunodiagnostics Systems Ltd
2012-10-17	Z-0042-2013	Class II	IDS-iSYS N-Mid¿ Osteocalcin	Immunodiagnostics Systems Ltd
2012-10-17	Z-0043-2013	Class II	IDS-iSYS N-Mid¿ Osteocalcin	Immunodiagnostics Systems Ltd
2012-10-17	Z-0044-2013	Class II	IDS-iSYS Intact PINP	Immunodiagnostics Systems Ltd
2012-10-17	Z-0045-2013	Class II	IDS-iSYS Intact PINP Control Set	Immunodiagnostics Systems Ltd
2012-10-17	Z-0046-2013	Class II	Access Folate Calibrators	Beckman Coulter Inc.
2012-10-17	Z-0047-2013	Class II	Access Folate WHO Calibrators	Beckman Coulter Inc.
2012-10-17	Z-0048-2013	Class II	Siemens syngo	Siemens Medical Solutions USA, Inc
2012-10-17	Z-0049-2013	Class II	Battery	Terumo Cardiovascular Systems Corporation
2012-10-17	Z-0050-2013	Class II	Battery	Terumo Cardiovascular Systems Corporation
2012-10-17	Z-0051-2013	Class II	Sarns Centrifugal System Control module	Terumo Cardiovascular Systems Corporation
2012-10-17	Z-0052-2013	Class II	Sarns Centrifugal System Control module	Terumo Cardiovascular Systems Corporation
2012-10-17	Z-0053-2013	Class II	Sarns Centrifugal System Control module System 9000 The Sarns…	Terumo Cardiovascular Systems Corporation
2012-10-17	Z-0054-2013	Class II	TORQ Sternal Closure Device	Kardium
2012-10-17	Z-0055-2013	Class II	3 PORT "OFF" MANIFOLD w/WASTE BAG	ICU Medical, Inc.
2012-10-10	Z-0001-2013	Class II	MIRS for MATRIX Spine System	Synthes USA HQ, Inc.
2012-10-10	Z-0002-2013	Class II	COULTER PrepPlus	Beckman Coulter Inc.
2012-10-10	Z-0003-2013	Class II	IMMAGE Immunochemistry Systems Rheumatoid Factor	Beckman Coulter Inc.
2012-10-10	Z-0004-2013	Class II	Male	Cure Medical LLC
2012-10-10	Z-0005-2013	Class II	IR1200	Animas Corporation
2012-10-10	Z-0006-2013	Class II	Endoscopic retrieval device	US Endoscopy Group Inc
2012-10-10	Z-0007-2013	Class II	BriteField illuminated Suction Device	Invuity, Inc.
2012-10-10	Z-0008-2013	Class III	Sterile	Gynex Corporation
2012-10-10	Z-0009-2013	Class II	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump	Accuro Medical Product LLC
2012-10-10	Z-0010-2013	Class II	8 Fr	C.R. Bard, Inc., Urological Division
2012-10-10	Z-0011-2013	Class II	Philips HeartStart XL M4735A Defibrillator/Monitors	Philips Healthcare Inc.
2012-10-10	Z-2072-2012	Class II	EOS X-ray Medical Diagnostic	Eos Imaging Inc

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