Medical device recalls reported in 2018

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Reported	Recall	Class	Product	Firm
2018-11-21	Z-0416-2019	Class II	OviTex Reinforced BioScaffold 6x10cm	AROA Biosurgery, LTD.
2018-11-21	Z-0417-2019	Class II	OviTex Reinforced BioScaffold 10x12cm	AROA Biosurgery, LTD.
2018-11-21	Z-0418-2019	Class II	OviTex Reinforced BioScaffold 10x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0419-2019	Class II	OviTex Reinforced BioScaffold 16x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0420-2019	Class II	OviTex Reinforced BioScaffold 20x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0421-2019	Class II	OviTex 1S Reinforced BioScaffold 4x8cm	AROA Biosurgery, LTD.
2018-11-21	Z-0422-2019	Class II	OviTex 1S Reinforced BioScaffold 6x10cm	AROA Biosurgery, LTD.
2018-11-21	Z-0423-2019	Class II	OviTex 1S Reinforced BioScaffold 10x12cm	AROA Biosurgery, LTD.
2018-11-21	Z-0424-2019	Class II	OviTex 1S Reinforced BioScaffold 10x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0425-2019	Class II	OviTex 1S Reinforced BioScaffold 16x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0426-2019	Class II	OviTex 1S Reinforced BioScaffold 18x22cm	AROA Biosurgery, LTD.
2018-11-21	Z-0427-2019	Class II	OviTex 1S Reinforced BioScaffold 20x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0428-2019	Class II	OviTex 2S Reinforced BioScaffold 6x10cm	AROA Biosurgery, LTD.
2018-11-21	Z-0429-2019	Class II	OviTex 2S Reinforced BioScaffold 10x12cm	AROA Biosurgery, LTD.
2018-11-21	Z-0430-2019	Class II	OviTex 2S Reinforced BioScaffold 10x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0431-2019	Class II	OviTex 2S Reinforced BioScaffold 16x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0432-2019	Class II	OviTex 2S Reinforced BioScaffold 18x22cm	AROA Biosurgery, LTD.
2018-11-21	Z-0433-2019	Class II	OviTex 2S Reinforced BioScaffold 20x20cm	AROA Biosurgery, LTD.
2018-11-21	Z-0434-2019	Class II	OviTex Reinforced BioScaffold 18x22cm	AROA Biosurgery, LTD.
2018-11-21	Z-0435-2019	Class II	OviTex 2S Reinforced BioScaffold 10x12cm	AROA Biosurgery, LTD.
2018-11-21	Z-0438-2019	Class II	The Spirit Plus Bed	Stryker Medical Division of Stryker Corporation
2018-11-21	Z-0439-2019	Class II	The Spirit Select Bed	Stryker Medical Division of Stryker Corporation
2018-11-21	Z-0440-2019	Class II	INFUSE Bone Graft X SMALL KIT REF 7510100	Medtronic Sofamor Danek USA Inc
2018-11-21	Z-0441-2019	Class II	Heron toilet and bath chair Model 880505-01 & 880505-11	R82 A/S
2018-11-21	Z-0442-2019	Class II	3	Arthrex, Inc.
2018-11-21	Z-0443-2019	Class II	bioM¿rieux NucliSENS easyMAG Lysis Buffer ref	bioMerieux, Inc.
2018-11-21	Z-0444-2019	Class II	Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml…	Espiner Medical Ltd
2018-11-21	Z-0445-2019	Class II	VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits	Luminex Corporation
2018-11-21	Z-0446-2019	Class II	-Outer Kit Box	BioFire Diagnostics, LLC
2018-11-21	Z-0447-2019	Class II	Affixus Hip Fracture Nail Left Deg 9x300mm	Zimmer Biomet, Inc.
2018-11-21	Z-0448-2019	Class II	Affixus Hip Fracture Nail Left 125 Deg 11x300mm	Zimmer Biomet, Inc.
2018-11-21	Z-0449-2019	Class II	Affixus Hip Fracture Nail Left 130 Deg 11x300mm	Zimmer Biomet, Inc.
2018-11-21	Z-0450-2019	Class II	Affixus Hip Fracture Nail Left 125 Deg 9x165mm	Zimmer Biomet, Inc.
2018-11-21	Z-0451-2019	Class II	Affixus Hip Fracture Nail 125 Deg 10x165mm	Zimmer Biomet, Inc.
2018-11-21	Z-0452-2019	Class II	Affixus Hip Fracture Nail 125 Deg 12x165mm	Zimmer Biomet, Inc.
2018-11-21	Z-0453-2019	Class II	Affixus Hip Fracture Nail 130 Deg 10x165mm	Zimmer Biomet, Inc.
2018-11-21	Z-0454-2019	Class II	Affixus Hip Fracture Nail 130 Deg 12x165mm	Zimmer Biomet, Inc.
2018-11-21	Z-0455-2019	Class II	Neodent¿ GM Mini Conical Abutment	Straumann Manufacturing, Inc.
2018-11-21	Z-0456-2019	Class II	Powdered Surgical Gloves	American Contract Systems, Inc.
2018-11-21	Z-0457-2019	Class II	ARTIS zee biplane systems with Material 10094141- a Angiographic…	Siemens Medical Solutions USA, Inc
2018-11-21	Z-0458-2019	Class II	ARTIS Q biplane with Material 10848282-	Siemens Medical Solutions USA, Inc
2018-11-21	Z-0459-2019	Class II	ARTIS Q	Siemens Medical Solutions USA, Inc
2018-11-21	Z-0460-2019	Class II	RadPRO	Virtual Imaging, Inc.
2018-11-21	Z-0461-2019	Class II	Parietex Composite Parastomal Mesh	Covidien LLC
2018-11-21	Z-0462-2019	Class II	Xper Flex Cardio Physiomonitoring System	Invivo Corporation
2018-11-21	Z-0464-2019	Class II	Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC…	Johnson & Johnson Surgical Vision Inc
2018-11-21	Z-0465-2019	Class II	Dimension Lipase Flex Reagent Cartridge	Siemens Healthcare Diagnostics, Inc.
2018-11-21	Z-0466-2019	Class II	Dimension Vista Lipase Flex Reagent Cartridge	Siemens Healthcare Diagnostics, Inc.
2018-11-21	Z-0467-2019	Class II	Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic…	Stryker Sustainability Solutions
2018-11-21	Z-0468-2019	Class II	Arrow AGB+ Multi-Lumen CVC Kit	Arrow International Inc
2018-11-21	Z-0469-2019	Class II	AIA-900 Analyzer	Tosoh Bioscience Inc
2018-11-14	Z-0269-2019	Class I	REF VV19F Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-11-14	Z-0360-2019	Class I	CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24…	Roche Diagnostics Corporation
2018-11-14	Z-0373-2019	Class II	Sterile Knee Instruments Disposable Fluted Headless Pins	Howmedica Osteonics Corp.
2018-11-14	Z-0374-2019	Class II	Centricity PACS-IW with Universal Viewer version 5	GE Healthcare, LLC
2018-11-14	Z-0375-2019	Class II	Centricity Universal Viewer with PACS-IW foundation 6	GE Healthcare, LLC
2018-11-14	Z-0376-2019	Class II	ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts…	Coltene Whaledent Inc
2018-11-14	Z-0377-2019	Class II	Endoform Dermal Template 2x2	AROA BIOSURGERY
2018-11-14	Z-0378-2019	Class II	Endoform Dermal Template 2x2	AROA BIOSURGERY
2018-11-14	Z-0379-2019	Class II	Endoform Dermal Template 4x5	AROA BIOSURGERY
2018-11-14	Z-0380-2019	Class II	Liquid Cardiac Control	Randox Laboratories Ltd.
2018-11-14	Z-0381-2019	Class II	Liquid Cardiac Control	Randox Laboratories Ltd.
2018-11-14	Z-0382-2019	Class II	Liquid Cardiac Control	Randox Laboratories Ltd.
2018-11-14	Z-0383-2019	Class II	EZ1 Advanced XL	Qiagen Sciences LLC
2018-11-14	Z-0384-2019	Class II	BD NEXIVA Closed IV Catheter System Dual Port 18GA 1	Becton Dickinson & Company
2018-11-14	Z-0385-2019	Class II	Alaris Infusion Pump administration sets labeled as: -Infusion Set…	CareFusion 303, Inc.
2018-11-14	Z-0386-2019	Class II	PCEA ASV Yellow Microbore	Becton Dickinson & Company
2018-11-14	Z-0387-2019	Class II	PCEA Kit ASV Yellow Stripe Microbore	Becton Dickinson & Company
2018-11-14	Z-0389-2019	Class III	Pointe Scientific AutoHDL/LDL Cholesterol Calibrator	Medtest Holdings, Inc.
2018-11-14	Z-0390-2019	Class II	Cordis POWERFLEX PRO PTA Dilatation Catheter	Cordis Corporation
2018-11-14	Z-0391-2019	Class I	TB Series Bipolar Pacing Leads	Oscor, Inc.
2018-11-14	Z-0392-2019	Class II	VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2	Ortho-Clinical Diagnostics
2018-11-14	Z-0393-2019	Class II	Biomet Microfixation RapidFlap System 12mm SpinDown Clamp	Zimmer Biomet, Inc.
2018-11-14	Z-0394-2019	Class II	Biomet Microfixation RapidFlap System	Zimmer Biomet, Inc.
2018-11-14	Z-0395-2019	Class II	Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp…	Zimmer Biomet, Inc.
2018-11-14	Z-0396-2019	Class II	Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp	Zimmer Biomet, Inc.
2018-11-14	Z-0397-2019	Class II	Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp…	Zimmer Biomet, Inc.
2018-11-14	Z-0398-2019	Class II	Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp	Zimmer Biomet, Inc.
2018-11-14	Z-0399-2019	Class II	StageOne Hip	Zimmer Biomet, Inc.
2018-11-14	Z-0400-2019	Class II	Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING	Safe N Simple, LLC
2018-11-14	Z-0401-2019	Class II	Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER	Safe N Simple, LLC
2018-11-14	Z-0402-2019	Class II	DT Medical -Hintermann Series H3 Poly Inlay	DT MedTech, LLC
2018-11-14	Z-0403-2019	Class II	DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number:…	DT MedTech, LLC
2018-11-14	Z-0404-2019	Class II	Medtronic Navigation 0-arm 02 Imaging System interventional…	Medtronic Navigation, Inc.-Littleton
2018-11-14	Z-0405-2019	Class II	FlareHawk Interbody Fusion System	Integrity Implants Inc.
2018-11-14	Z-0406-2019	Class II	Medtronic CareLink 2090 Programmer	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-11-14	Z-0407-2019	Class II	Medtronic CareLink Encore 29901 Programmer	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-11-14	Z-0408-2019	Class II	CyberKnife M6	Accuray Incorporated
2018-11-14	Z-0409-2019	Class II	Dimension Thermal Chamber Motor Cable located in the following…	Siemens Healthcare Diagnostics, Inc.
2018-11-14	Z-0410-2019	Class III	R&D systems	R & D Systems, Inc.
2018-11-07	Z-0099-2019	Class I	Cardiosave Hybrid IABP	Maquet Datascope Corp - Cardiac Assist Division
2018-11-07	Z-0100-2019	Class I	Cardiosave Rescue IABP	Maquet Datascope Corp - Cardiac Assist Division
2018-11-07	Z-0281-2019	Class II	BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301	Leica Microsystems, Inc.
2018-11-07	Z-0282-2019	Class II	Arrow AGB + Multi-Lumen CVC Kit	Arrow International Inc
2018-11-07	Z-0283-2019	Class III	Palcam Agar Base	Acumedia Manufacturers, Inc.
2018-11-07	Z-0284-2019	Class III	Campylobacter Blood Free Selective Medium	Acumedia Manufacturers, Inc.
2018-11-07	Z-0285-2019	Class II	Magellan LeadCare¿ II Blood Lead Test Kit	Magellan Diagnostics, Inc.
2018-11-07	Z-0286-2019	Class I	EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen…	Zimmer Biomet, Inc.
2018-11-07	Z-0287-2019	Class I	SpF PLUS-Mini	Zimmer Biomet, Inc.
2018-11-07	Z-0288-2019	Class II	Hoffman LRF Hexapod Strut	Stryker GmbH
2018-11-07	Z-0289-2019	Class II	Hoffman LRF Hexapod Strut	Stryker GmbH
2018-11-07	Z-0290-2019	Class II	Hoffman LRF Hexapod Strut	Stryker GmbH
2018-11-07	Z-0291-2019	Class II	Hoffman LRF Hexapod Strut	Stryker GmbH
2018-11-07	Z-0292-2019	Class II	IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1	CMP Industries, Llc
2018-11-07	Z-0293-2019	Class II	Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1	CMP Industries, Llc
2018-11-07	Z-0294-2019	Class II	RayStation 4	RAYSEARCH LABORATORIES AB
2018-11-07	Z-0295-2019	Class II	Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product…	Arthrex, Inc.
2018-11-07	Z-0296-2019	Class II	FilmArray Blood Culture Identification	BioFire Diagnostics, LLC
2018-11-07	Z-0297-2019	Class II	Multix Fusion system is a radiographic system: Models: Multix Fusion…	Siemens Medical Solutions USA, Inc
2018-11-07	Z-0298-2019	Class II	AXIOM Multix MT	Siemens Medical Solutions USA, Inc
2018-11-07	Z-0299-2019	Class II	Ysio	Siemens Medical Solutions USA, Inc
2018-11-07	Z-0300-2019	Class II	Ysio MAX	Siemens Medical Solutions USA, Inc
2018-11-07	Z-0301-2019	Class II	Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001…	Roche Diagnostics Corporation
2018-11-07	Z-0302-2019	Class II	Vereos PET/CT	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0303-2019	Class II	Brilliance Big Bore Oncology CT	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0304-2019	Class II	Brilliance 64	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0305-2019	Class II	Brilliance iCT	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0306-2019	Class II	IQon Spectral CT	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0307-2019	Class II	Brilliance Big Bore Radiology CT	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0308-2019	Class II	Ingenuity CT	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0309-2019	Class II	Ingenuity Core	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0310-2019	Class II	Ingenuity Core 128	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0311-2019	Class II	Brilliance iCT SP	Philips Medical Systems (Cleveland) Inc
2018-11-07	Z-0312-2019	Class II	BD Max Instrument Reader Spare Part	Becton Dickinson & Co.
2018-11-07	Z-0313-2019	Class II	BD Max Instrument	Becton Dickinson & Co.
2018-11-07	Z-0314-2019	Class II	Zilver 518 Biliary Stent 4mm x 20mm	Cook Medical Incorporated
2018-11-07	Z-0315-2019	Class II	Zilver 518 Biliary Stent 4mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0316-2019	Class II	Zilver 518 Biliary Stent 4mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0317-2019	Class II	Zilver 518 Biliary Stent 4mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0318-2019	Class II	Zilver 518 Biliary Stent 4mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0319-2019	Class II	Zilver 518 Biliary Stent 5mm x 20mm	Cook Medical Incorporated
2018-11-07	Z-0320-2019	Class II	Zilver 518 Biliary Stent 5mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0321-2019	Class II	Zilver 518 Biliary Stent 5mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0322-2019	Class II	Zilver 518 Biliary Stent 5mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0323-2019	Class II	Zilver 518 Biliary Stent 5mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0324-2019	Class II	Zilver 635 Biliary Stent 12mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0325-2019	Class II	Zilver 635 Biliary Stent 12mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0326-2019	Class II	Zilver 635 Biliary Stent 12mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0327-2019	Class II	Zilver 635 Biliary Stent 12mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0328-2019	Class II	Zilver 635 Biliary Stent 14mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0329-2019	Class II	Zilver 635 Biliary Stent 14mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0330-2019	Class II	Zilver 635 Biliary Stent 14mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0331-2019	Class II	Zilver 635 Biliary Stent 4mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0332-2019	Class II	Zilver 635 Biliary Stent 5mm x 20mm	Cook Medical Incorporated
2018-11-07	Z-0333-2019	Class II	Zilver 635 Biliary Stent 5mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0334-2019	Class II	Zilver 635 Biliary Stent 5mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0335-2019	Class II	Zilver 635 Biliary Stent 5mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0336-2019	Class II	Zilver 635 Biliary Stent 5mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0337-2019	Class II	Zilver 635 Biliary Stent 12mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0338-2019	Class II	Zilver 635 Biliary Stent 12mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0339-2019	Class II	Zilver 635 Biliary Stent 12mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0340-2019	Class II	Zilver 635 Biliary Stent 12mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0341-2019	Class II	Zilver 635 Biliary Stent 14mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0342-2019	Class II	Zilver 635 Biliary Stent 14mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0343-2019	Class II	Zilver 635 Biliary Stent 14mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0344-2019	Class II	Zilver 635 Biliary Stent 14mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0345-2019	Class II	Zilver 635 Biliary Stent 4mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0346-2019	Class II	Zilver 635 Biliary Stent 5mm x 20mm	Cook Medical Incorporated
2018-11-07	Z-0347-2019	Class II	Zilver 635 Biliary Stent 5mm x 30mm	Cook Medical Incorporated
2018-11-07	Z-0348-2019	Class II	Zilver 635 Biliary Stent 5mm x 40mm	Cook Medical Incorporated
2018-11-07	Z-0349-2019	Class II	Zilver 635 Biliary Stent 5mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0350-2019	Class II	Zilver 635 Biliary Stent 5mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0351-2019	Class II	Zilver Biliary 518 Stent 5mm x 60mm	Cook Medical Incorporated
2018-11-07	Z-0352-2019	Class II	Zilver 635 Biliary Stent 14mm x 80mm	Cook Medical Incorporated
2018-11-07	Z-0353-2019	Class III	Intelligent Peri-Analytical Workstation	Beckman Coulter Inc.
2018-11-07	Z-0354-2019	Class III	Software Package	Beckman Coulter Inc.
2018-11-07	Z-0355-2019	Class III	Software Package	Beckman Coulter Inc.
2018-11-07	Z-0356-2019	Class III	Software Package	Beckman Coulter Inc.
2018-11-07	Z-0357-2019	Class III	Software Package	Beckman Coulter Inc.
2018-11-07	Z-0358-2019	Class III	Sorting-Drive Product Part	Beckman Coulter Inc.
2018-11-07	Z-0359-2019	Class III	Sorting-Drive Professional Part	Beckman Coulter Inc.
2018-11-07	Z-0361-2019	Class II	FlexLab	Inpeco S.A.
2018-11-07	Z-0362-2019	Class II	Volumat MC Agilia Volumetric Infusion Pump	Fresenius Vial Sa
2018-11-07	Z-0363-2019	Class II	EXACTAMIX Empty EVA Bags	Baxter Healthcare Corporation
2018-11-07	Z-0364-2019	Class II	EXACTAMIX Empty EVA Bags	Baxter Healthcare Corporation
2018-11-07	Z-0365-2019	Class II	EXACTAMIX Empty EVA Bags	Baxter Healthcare Corporation
2018-11-07	Z-0366-2019	Class II	EXACTAMIX Empty EVA Bags	Baxter Healthcare Corporation
2018-11-07	Z-0367-2019	Class II	EXACTAMIX Empty EVA Bags	Baxter Healthcare Corporation
2018-11-07	Z-0368-2019	Class II	3M Fast Release Varnish	3M Company - Health Care Business
2018-11-07	Z-0372-2019	Class II	EVO Excel	Siemens Medical Solutions USA, Inc.
2018-10-31	Z-0185-2019	Class I	CyPass System 241-S	Alcon Research, LTD.
2018-10-31	Z-0186-2019	Class I	CyPass System 241	Alcon Research, LTD.
2018-10-31	Z-0187-2019	Class I	CyPass ULTRA SYSTEM	Alcon Research, LTD.
2018-10-31	Z-0188-2019	Class I	CyPass System 241	Alcon Research, LTD.
2018-10-31	Z-0196-2019	Class II	Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM	Medacta Usa Inc
2018-10-31	Z-0197-2019	Class II	TRINIAS Digital Angiographic System intended to be used for cardiac…	Shimadzu Medical Systems Usa Com
2018-10-31	Z-0198-2019	Class II	J-Plasma Precise 360	Bovie Medical Corporation
2018-10-31	Z-0199-2019	Class II	Nuclear Magnetic Resonance Imaging Systems that are indicated for use…	Canon Medical System, USA, INC.
2018-10-31	Z-0200-2019	Class II	Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK	Smith & Nephew, Inc.
2018-10-31	Z-0201-2019	Class II	GE Healthcare	GE Medical Systems, LLC
2018-10-31	Z-0202-2019	Class II	Boston Scientific Maestro 4000 Cardiac Ablation System	Boston Scientific Corporation
2018-10-31	Z-0203-2019	Class II	IM Abbott Alinity ci-series	Data Innovations, LLC
2018-10-31	Z-0204-2019	Class II	MyLab Alpha	ESAOTE S.P.A.
2018-10-31	Z-0205-2019	Class II	MyLab Gamma	ESAOTE S.P.A.
2018-10-31	Z-0206-2019	Class II	MyLab Seven	ESAOTE S.P.A.
2018-10-31	Z-0207-2019	Class II	Tritanium TL Steerable Inserter	Howmedica Osteonics Corp.
2018-10-31	Z-0208-2019	Class II	Mitek Screw and Washer Depth Gauge	DePuy Mitek, Inc., a Johnson & Johnson Co.
2018-10-31	Z-0209-2019	Class II	APTIO INPUT/OUTPUT MODULE	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0210-2019	Class II	APTIO RACK INPUT MODULE	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0211-2019	Class II	APTIO CENTRIFUGE MODULE	Siemens Healthcare Diagnostics, Inc.

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