Medical device recalls reported in 2019

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Reported	Recall	Class	Product	Firm
2019-02-27	Z-0840-2019	Class II	Randox CALCIUM	Randox Laboratories Ltd.
2019-02-27	Z-0841-2019	Class II	daVinci Harmonic ACE Curved Shears	Intuitive Surgical, Inc.
2019-02-27	Z-0842-2019	Class II	Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent…	Smiths Medical ASD Inc.
2019-02-27	Z-0843-2019	Class II	Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator…	Smiths Medical ASD Inc.
2019-02-27	Z-0844-2019	Class II	Vitros Myoglobin Calibrators	Ortho Clinical Diagnostics Inc
2019-02-27	Z-0845-2019	Class II	Medtronic Power Supply 26907	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-27	Z-0846-2019	Class II	Pilling COOLEY SUMP-SUCTION TUBE	Teleflex Medical
2019-02-27	Z-0847-2019	Class II	VITEK 2 AST-N351 Test Kit	bioMerieux, Inc.
2019-02-27	Z-0848-2019	Class II	VITROS Chemistry Products VALP Reagent Pack	Ortho-Clinical Diagnostics
2019-02-27	Z-0849-2019	Class II	AMIA Automated Peritoneal Dialysis System Product Usage: It is…	Baxter Healthcare Corporation
2019-02-27	Z-0850-2019	Class II	Kaguya Automated Peritoneal Dialysis System Product Usage: It is…	Baxter Healthcare Corporation
2019-02-27	Z-0851-2019	Class II	Check-Flo Performer Introducer	Cook Inc.
2019-02-27	Z-0852-2019	Class II	Stingray" Guidewire	Boston Scientific Corporation
2019-02-27	Z-0853-2019	Class II	PageWriter TC70	Philips North America, LLC
2019-02-27	Z-0854-2019	Class II	PageWriter TC50	Philips North America, LLC
2019-02-27	Z-0855-2019	Class II	PageWriter TC30	Philips North America, LLC
2019-02-27	Z-0856-2019	Class II	PageWriter TC20	Philips North America, LLC
2019-02-27	Z-0857-2019	Class II	PageWriter TC70 w/trolley Government Bundle	Philips North America, LLC
2019-02-27	Z-0858-2019	Class II	PageWriter TC70 w/o trolley Government Bundle	Philips North America, LLC
2019-02-27	Z-0859-2019	Class II	PageWriter TC30 w/ trolley Government Bundle	Philips North America, LLC
2019-02-27	Z-0860-2019	Class II	PageWriter TC50 Government Bundle	Philips North America, LLC
2019-02-27	Z-0861-2019	Class II	PageWriter TC30 w/o trolley Government Bundle	Philips North America, LLC
2019-02-27	Z-0864-2019	Class II	TRINIAS for diagnostic imaging and interventional procedures in…	Shimadzu Medical Systems Usa Com
2019-02-20	Z-0612-2019	Class II	Stationary Fluoroscopic X-ray System CombiDiagnost R90	Philips Medical Systems Gmbh, DMC
2019-02-20	Z-0806-2019	Class I	Medtronic implantable pulse generator: ADAPTA	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0807-2019	Class I	Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0808-2019	Class I	Medtronic implantable pulse generator: RELIA	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0809-2019	Class I	Medtronic implantable pulse generator: SENSIA	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0810-2019	Class I	Medtronic implantable pulse generator: Sphera DR MRI SureScan	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0811-2019	Class I	Medtronic implantable pulse generator: Versa	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0812-2019	Class I	vitatron	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-20	Z-0821-2019	Class II	MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an…	Elekta, Inc.
2019-02-20	Z-0822-2019	Class III	Vergene Amplification Tray	Luminex Corporation
2019-02-20	Z-0823-2019	Class II	Ingenuity TF PET/CT	Philips Medical Systems (Cleveland) Inc
2019-02-20	Z-0824-2019	Class II	ATLAS Loading Car	Steris Corporation
2019-02-20	Z-0825-2019	Class II	Hemotherm CE Dual Reservoir Cooler/Heater	Cincinnati Sub-Zero Products LLC, a Gentherm Company
2019-02-20	Z-0826-2019	Class II	21Y14 PushValve Product Usage: The PushValves/ MagValves is intended…	Ottobock Orthopedic Industrie
2019-02-20	Z-0827-2019	Class II	21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves…	Ottobock Orthopedic Industrie
2019-02-20	Z-0828-2019	Class II	21Y15 MagValve Product Usage: The PushValves/ MagValves is intended…	Ottobock Orthopedic Industrie
2019-02-20	Z-0829-2019	Class II	COBRA FUSION 50	AtriCure, Inc.
2019-02-20	Z-0830-2019	Class II	COBRA FUSION 150 Ablation System	AtriCure, Inc.
2019-02-20	Z-0831-2019	Class II	COBRA FUSION 150 Ablation System	AtriCure, Inc.
2019-02-20	Z-0832-2019	Class II	COBRA FUSION 150 Ablation System	AtriCure, Inc.
2019-02-20	Z-0833-2019	Class II	Genius Knee Cemented Tibial Component Product Usage: Knee replacement…	Signature Orthopedics Pty Limited
2019-02-20	Z-0834-2019	Class II	Genius Knee Cemented CR Femoral Component Product Usage: Knee…	Signature Orthopedics Pty Limited
2019-02-20	Z-0835-2019	Class II	Edward Lifesciences	Edwards Lifesciences, LLC
2019-02-20	Z-0836-2019	Class II	HORIZON Ez Arm	The Magstim Company Limited
2019-02-20	Z-0837-2019	Class II	OMNI K1 Broach Handle	OMNIlife science Inc.
2019-02-13	Z-0710-2019	Class I	Portex 350 ml Sterile Water Humidifier w/5psi Adapt	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0711-2019	Class I	Portex 550 ml Sterile Water Humidifier w/5psi Adapt	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0712-2019	Class I	Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0713-2019	Class I	Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0714-2019	Class I	Intermed 350 ml Sterile Water Humidifier w/5psi Adapt	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0715-2019	Class I	Portex 550 ml Sterile Water Humidifier w/5psi Adapt	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0716-2019	Class I	Intermed 550 ml Sterile Water Humidifier w/5psi Adapt	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0717-2019	Class I	Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0718-2019	Class I	Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0719-2019	Class I	Portex Unit Dose 5 ml Normal Saline	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0720-2019	Class I	Portex Unit Dose 15 ml Normal Saline ¿	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0721-2019	Class I	Portex 5ml Normal Saline	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0722-2019	Class I	Medline Prefilled 550 ml Sterile¿¿ ¿	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2019-02-13	Z-0773-2019	Class II	NeuViz 128 Multi-slice CT Scanner System with software version 1	NEUSOFT MEDICAL SYSTEMS IMP & EX
2019-02-13	Z-0776-2019	Class II	Revolution CT systems with the SmartStep Option The system is…	GE Healthcare, LLC
2019-02-13	Z-0787-2019	Class I	CoaguChek XS PT Test	TERRIFIC CARE LLC
2019-02-13	Z-0792-2019	Class III	BD FACSLyric 3L 10C with FACSuite Clinical Software v1	Becton, Dickinson and Company, BD Biosciences
2019-02-13	Z-0793-2019	Class II	GE Healthcare Centricity Universal Viewer Breast Imaging Centricity…	GE Healthcare, LLC
2019-02-13	Z-0794-2019	Class III	Ascension Modular Radial Head	Ascension Orthopedics, Inc
2019-02-13	Z-0795-2019	Class II	MEDTRONIC CARELINK 2090 programmer	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-13	Z-0796-2019	Class II	MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-02-13	Z-0797-2019	Class II	Henry Schein CU 1000 Halogen Curing Light	Handpiece Headquarters
2019-02-13	Z-0798-2019	Class II	ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or…	Abbott Ireland Diagnostics Division
2019-02-13	Z-0799-2019	Class II	ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or…	Abbott Ireland Diagnostics Division
2019-02-13	Z-0800-2019	Class II	BARD SureStep Foley Tray System Bardex I	Bard Medical Division
2019-02-13	Z-0801-2019	Class II	Product: ABL800 FLEX with Crea	Radiometer America Inc
2019-02-13	Z-0802-2019	Class II	ARJOHUNTLEIGH GETINGE GROUP	Arjohuntleigh Magog
2019-02-13	Z-0803-2019	Class II	SureStep	Bard Medical Division
2019-02-13	Z-0804-2019	Class II	Richard Wolf Bronchoscope Tubes	Richard Wolf GmbH
2019-02-13	Z-0813-2019	Class II	Naera Hospital Bassinet	Stryker Medical Division of Stryker Corporation
2019-02-13	Z-0814-2019	Class II	"J" Type Bone Marrow Needle 11ga x 10 cm	Angiotech (Manan Medical Products, Inc.)
2019-02-13	Z-0815-2019	Class II	J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual…	Angiotech (Manan Medical Products, Inc.)
2019-02-13	Z-0816-2019	Class II	J Type Bone Marrow Needle 13ga x 6cm	Angiotech (Manan Medical Products, Inc.)
2019-02-13	Z-0817-2019	Class II	Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula…	Angiotech (Manan Medical Products, Inc.)
2019-02-13	Z-0818-2019	Class II	Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm-…	Angiotech (Manan Medical Products, Inc.)
2019-02-13	Z-0819-2019	Class II	Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm	Angiotech (Manan Medical Products, Inc.)
2019-02-13	Z-0820-2019	Class II	Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm	Angiotech (Manan Medical Products, Inc.)
2019-02-06	Z-0762-2019	Class I	Edwards Lifesciences Swan Ganz Thermodilution Catheter	Edwards Lifesciences, LLC
2019-02-06	Z-0763-2019	Class I	Edwards Lifesciences Swan Ganz Thermodilution Catheter	Edwards Lifesciences, LLC
2019-02-06	Z-0764-2019	Class I	Edwards Lifesciences Swan Ganz Thermodilution Catheter	Edwards Lifesciences, LLC
2019-02-06	Z-0765-2019	Class I	Edwards Lifesciences Swan Ganz Thermodilution Catheter	Edwards Lifesciences, LLC
2019-02-06	Z-0767-2019	Class I	Vial2BAG DC 13mm	WEST PHARMA. SERVICES IL, LTD
2019-02-06	Z-0768-2019	Class I	Vial2BAG Transfer Device	WEST PHARMA. SERVICES IL, LTD
2019-02-06	Z-0769-2019	Class I	Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C	WEST PHARMA. SERVICES IL, LTD
2019-02-06	Z-0774-2019	Class II	COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE	Wilson-Cook Medical Inc.
2019-02-06	Z-0775-2019	Class II	COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE	Wilson-Cook Medical Inc.
2019-02-06	Z-0777-2019	Class III	RP RIVERPOINT MEDICAL 18G Brachy Grid B&K	Riverpoint Medical, LLC
2019-02-06	Z-0778-2019	Class II	Cell Saver 5/5+ Bowl Set	Haemonetics Corporation
2019-02-06	Z-0779-2019	Class II	Cell Saver Elite Processing Kit	Haemonetics Corporation
2019-02-06	Z-0780-2019	Class II	Atellica IM 1300 Analyzer	Siemens Healthcare Diagnostics, Inc.
2019-02-06	Z-0781-2019	Class II	Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical…	Siemens Healthcare Diagnostics, Inc.
2019-02-06	Z-0782-2019	Class II	Atellica CH 930 Analyzer	Siemens Healthcare Diagnostics, Inc.
2019-02-06	Z-0783-2019	Class II	Atellica Sample Handler Prime	Siemens Healthcare Diagnostics, Inc.
2019-02-06	Z-0784-2019	Class II	Anti-HAV IgM test System	Roche Diagnostics Corporation
2019-02-06	Z-0785-2019	Class II	RESERVOIR "Y" ADAPTER	Medtronic Perfusion Systems
2019-02-06	Z-0786-2019	Class II	SUCTION / ANTICOAGULATION ASSEMBLY	Medtronic Perfusion Systems
2019-02-06	Z-0788-2019	Class II	GE HEALTHCARE LOGIQ P6 Premium TruScan	GE Healthcare, LLC
2019-02-06	Z-0789-2019	Class II	Alinity i Processing Module	Abbott Gmbh & Co. KG
2019-02-06	Z-0790-2019	Class II	Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC	XTANT MEDICAL INC
2019-02-06	Z-0791-2019	Class II	3M	3M Company - Health Care Business
2019-01-30	Z-0736-2019	Class I	VentStar Basic 180	Draeger Medical, Inc.
2019-01-30	Z-0737-2019	Class I	VentStar Basic 250	Draeger Medical, Inc.
2019-01-30	Z-0738-2019	Class I	VentStar Basic	Draeger Medical, Inc.
2019-01-30	Z-0739-2019	Class I	VentStar Basic	Draeger Medical, Inc.
2019-01-30	Z-0740-2019	Class I	VentStar Watertrap	Draeger Medical, Inc.
2019-01-30	Z-0741-2019	Class I	VentStar Anesthesia WT	Draeger Medical, Inc.
2019-01-30	Z-0742-2019	Class I	ID Circuit Watertrap	Draeger Medical, Inc.
2019-01-30	Z-0743-2019	Class I	ID Circuit Basic 250	Draeger Medical, Inc.
2019-01-30	Z-0744-2019	Class I	ID Circuit Basic 180	Draeger Medical, Inc.
2019-01-30	Z-0753-2019	Class II	Percuvance	Teleflex Medical
2019-01-30	Z-0754-2019	Class II	Percuvance	Teleflex Medical
2019-01-30	Z-0755-2019	Class II	16600 / Fetzer Surgical Luikart Simpson OB Forceps14"	Fetzer Medical GmbH & Co. KG
2019-01-30	Z-0756-2019	Class II	12002 / Boss Instruments Ltd	Fetzer Medical GmbH & Co. KG
2019-01-30	Z-0757-2019	Class II	16600 / Fetzer Surgical De Lee Obstetric Forceps	Fetzer Medical GmbH & Co. KG
2019-01-30	Z-0758-2019	Class II	12002 / Boss Instruments Simpson OB Forceps	Fetzer Medical GmbH & Co. KG
2019-01-30	Z-0759-2019	Class II	Heating Profile PRISMAFLO II S blood return warmer for Prismaflex…	Stihler Electronic Gmbh
2019-01-30	Z-0760-2019	Class II	Heating Profile PRISMAFLO II S blood return warmer for Prismaflex…	Stihler Electronic Gmbh
2019-01-30	Z-0761-2019	Class II	Heating Profile PRISMAFLO II blood return warmer for Prismaflex…	Stihler Electronic Gmbh
2019-01-30	Z-0766-2019	Class II	BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter	Stryker Sustainability Solutions
2019-01-30	Z-0770-2019	Class II	Perfusion Pack	LivaNova USA
2019-01-30	Z-0771-2019	Class II	Eclipse	Varian Medical Systems, Inc.
2019-01-30	Z-0772-2019	Class II	Leica M220 F12 surgical microscope The Leica M220 F12 surgical…	Leica Microsystems, Inc.
2019-01-23	Z-0723-2019	Class II	Arrow CVC 2 Lumen	Arrow International Inc
2019-01-23	Z-0724-2019	Class II	Arthrex Suture Anchor	Arthrex, Inc.
2019-01-23	Z-0725-2019	Class II	MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange…	Canadian Hospital Specialties
2019-01-23	Z-0726-2019	Class II	Visions PV	Volcano Corporation
2019-01-23	Z-0727-2019	Class II	Visions PV	Volcano Corporation
2019-01-23	Z-0728-2019	Class II	BiMobile UHMWPE Liner: ID-28mm/OD-50mm	Waldemar Link GmbH & Co. KG (Mfg Site)
2019-01-23	Z-0729-2019	Class II	BiMobile UHMWPE Liner: ID-28mm/OD-54mm	Waldemar Link GmbH & Co. KG (Mfg Site)
2019-01-23	Z-0730-2019	Class II	SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM	Smith & Nephew, Inc.
2019-01-23	Z-0731-2019	Class II	iTotal Hip Replacement System	Conformis, Inc.
2019-01-23	Z-0732-2019	Class II	PREMIER Cryptococcal Antigen	Meridian Bioscience Inc
2019-01-23	Z-0733-2019	Class II	LINK STEM with Microporous Surface MP Reconstruction Prosthesis	Waldemar Link GmbH & Co. KG (Mfg Site)
2019-01-23	Z-0734-2019	Class II	Maximum Variable Pitch Compression Tray Base	Zimmer Biomet, Inc.
2019-01-23	Z-0735-2019	Class II	Maximum Variable Pitch Compression Screw Caddy	Zimmer Biomet, Inc.
2019-01-23	Z-0745-2019	Class II	MAVIG Portegra or Portegra2 Overhead Counterpoise System	Bayer Medical Care, Inc.
2019-01-23	Z-0746-2019	Class II	DeRoyal	DeRoyal Industries Inc
2019-01-23	Z-0747-2019	Class II	PERMA-HAND Silk Suture Size 5	Ethicon, Inc.
2019-01-23	Z-0748-2019	Class II	U by Kotex¿ Sleek¿	Kimberly-Clark Corporation
2019-01-23	Z-0749-2019	Class II	U by Kotex¿ Sleek¿	Kimberly-Clark Corporation
2019-01-23	Z-0750-2019	Class II	U by Kotex¿ Sleek¿	Kimberly-Clark Corporation
2019-01-23	Z-0751-2019	Class II	U by Kotex¿ Sleek¿	Kimberly-Clark Corporation
2019-01-23	Z-0752-2019	Class III	Porcine Anorganic Bone Mineral 4	Collagen Matrix Inc
2019-01-16	Z-0692-2019	Class II	DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system…	Agfa-Gevaert, N.V.
2019-01-16	Z-0693-2019	Class II	Various GE Magnetic Resonance System on-site software version Product…	GE Healthcare, LLC
2019-01-16	Z-0694-2019	Class II	Ingenia Elition S	Philips Medical Systems Nederlands
2019-01-16	Z-0695-2019	Class II	PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01…	Ethicon Endo-Surgery Inc
2019-01-16	Z-0696-2019	Class II	PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03…	Ethicon Endo-Surgery Inc
2019-01-16	Z-0697-2019	Class II	ddRCombi Plus FP	Swissray Medical AG
2019-01-16	Z-0698-2019	Class II	Proteus 235 Product Usage: The Proton Therapy System	Ion Beam Applications S.A.
2019-01-16	Z-0699-2019	Class III	Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open…	Boston Scientific Corporation
2019-01-16	Z-0700-2019	Class III	IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open…	Boston Scientific Corporation
2019-01-16	Z-0701-2019	Class III	IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open…	Boston Scientific Corporation
2019-01-16	Z-0702-2019	Class II	Presource Kit Total Joint Pack containing a double-wrapped basin…	Cardinal Health Inc.
2019-01-16	Z-0703-2019	Class II	Discover VH/Millennium VG Nuclear Medicine Imaging System	GE Healthcare, LLC
2019-01-16	Z-0704-2019	Class II	VariCam	GE Healthcare, LLC
2019-01-16	Z-0705-2019	Class II	MEVION S250i	Mevion Medical Systems, Inc.
2019-01-16	Z-0706-2019	Class II	Elekta Unity	Elekta Limited
2019-01-16	Z-0707-2019	Class II	Siemens Biograph Horizon PET/CT System	Siemens Medical Solutions USA, Inc.
2019-01-16	Z-0708-2019	Class II	Biomet DVR Crosslock Screws- 2	Zimmer Biomet, Inc.
2019-01-16	Z-0709-2019	Class II	Biomet DVR Crosslock Screws- 2	Zimmer Biomet, Inc.
2019-01-09	Z-0552-2019	Class I	StealthStation Cranial and Synergy Cranial Depth Gauge:…	Medtronic Navigation, Inc.
2019-01-09	Z-0687-2019	Class II	VITROS Anti-HBe Reagent Pack	ORTHO-CLINICAL DIAGNOSTICS
2019-01-09	Z-0688-2019	Class II	VITROS HBeAg Reagent	ORTHO-CLINICAL DIAGNOSTICS
2019-01-09	Z-0689-2019	Class II	VITROS NT-proBNP Reagent	ORTHO-CLINICAL DIAGNOSTICS
2019-01-09	Z-0690-2019	Class II	Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose…	Ultradent Products, Inc.
2019-01-09	Z-0691-2019	Class III	Quantikine¿ IVD¿ ELISA	R & D Systems, Inc.
2019-01-02	Z-0660-2019	Class II	SP CAL	Randox Laboratories Ltd.
2019-01-02	Z-0661-2019	Class II	Thermoset Room Temperature Closed Loop Injectate Delivery System	ICU Medical, Inc.
2019-01-02	Z-0662-2019	Class II	Iced Thermoset Closed-Loop Injectate Delivery System for cold…	ICU Medical, Inc.
2019-01-02	Z-0663-2019	Class II	Iced Thermoset Closed-Loop Injectate Delivery System for cold…	ICU Medical, Inc.
2019-01-02	Z-0664-2019	Class II	Alinity i TSH Reagent Kit	Abbott Ireland Diagnostics Division
2019-01-02	Z-0665-2019	Class II	Alinity i Free T4 Reagent Kit	Abbott Ireland Diagnostics Division
2019-01-02	Z-0666-2019	Class II	Alinity i Total Beta-hCG Reagent Kit	Abbott Ireland Diagnostics Division
2019-01-02	Z-0667-2019	Class II	Alinity i Estradiol Reagent Kit	Abbott Ireland Diagnostics Division
2019-01-02	Z-0668-2019	Class II	Alinity i Progesterone Reagent Kit	Abbott Ireland Diagnostics Division
2019-01-02	Z-0669-2019	Class II	Alinity i 25-OH Vitamin D Reagent Kit	Abbott Ireland Diagnostics Division
2019-01-02	Z-0670-2019	Class II	NeoSpan SuperElastic Compression Staple w/Instruments	In2bones USA, LLC
2019-01-02	Z-0671-2019	Class II	AIA-PACK B12	Tosoh Bioscience Inc
2019-01-02	Z-0672-2019	Class II	AIA-PACK Folate	Tosoh Bioscience Inc
2019-01-02	Z-0673-2019	Class II	ST AIA-PACK FT3	Tosoh Bioscience Inc
2019-01-02	Z-0674-2019	Class II	ST AIA-PACK Testosterone	Tosoh Bioscience Inc
2019-01-02	Z-0675-2019	Class II	ST AIA-PACK Homocysteine	Tosoh Bioscience Inc
2019-01-02	Z-0676-2019	Class II	ST AIA-PACK ACTH	Tosoh Bioscience Inc
2019-01-02	Z-0677-2019	Class II	HydroSet XT Injectable HA Bone Cement	Howmedica Osteonics Corp.
2019-01-02	Z-0678-2019	Class II	HydroSet XT Injectable HA Bone Cement	Howmedica Osteonics Corp.
2019-01-02	Z-0679-2019	Class II	RayStation 3	RAYSEARCH LABORATORIES AB
2019-01-02	Z-0680-2019	Class II	GEM Coupler Forceps	Baxter Healthcare Corporation
2019-01-02	Z-0681-2019	Class II	Laparotomy Sponge	Medical Action Industries Inc
2019-01-02	Z-0682-2019	Class II	ABL800 analyzer	Radiometer America Inc
2019-01-02	Z-0683-2019	Class II	Medtronic MiniMed 630G 6025805-003_C	Medtronic Inc.
2019-01-02	Z-0685-2019	Class II	I-View¿ Contrast Enhanced Digital Mammography	Hologic, Inc.

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