Medical device recalls reported in 2018

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Reported	Recall	Class	Product	Firm
2018-04-04	Z-1197-2018	Class II	AIM Tibial Nails intramedullary fixation rod	Zimmer Biomet, Inc.
2018-04-04	Z-1198-2018	Class II	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered…	GE Healthcare, LLC
2018-04-04	Z-1199-2018	Class II	DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be…	GE Healthcare, LLC
2018-04-04	Z-1201-2018	Class II	COACH¿ Self-Adhering Sports Wrap	Johnson & Johnson Consumer, Inc.
2018-04-04	Z-1202-2018	Class II	COACH¿ Self-Adhering Sports Wrap	Johnson & Johnson Consumer, Inc.
2018-04-04	Z-1203-2018	Class II	Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap	Johnson & Johnson Consumer, Inc.
2018-04-04	Z-1204-2018	Class II	Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap	Johnson & Johnson Consumer, Inc.
2018-04-04	Z-1205-2018	Class II	Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap	Johnson & Johnson Consumer, Inc.
2018-04-04	Z-1206-2018	Class II	Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap	Johnson & Johnson Consumer, Inc.
2018-04-04	Z-1207-2018	Class I	6F Taiga Guiding Catheter	Medtronic Inc
2018-04-04	Z-1208-2018	Class II	Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series…	Covidien LLC
2018-04-04	Z-1209-2018	Class II	ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS	Johnson & Johnson Vision Care, Inc.
2018-04-04	Z-1210-2018	Class II	ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR	Johnson & Johnson Vision Care, Inc.
2018-04-04	Z-1211-2018	Class II	1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses	Johnson & Johnson Vision Care, Inc.
2018-04-04	Z-1212-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter	Konica Minolta Medical Imaging USA, Inc.
2018-04-04	Z-1213-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter	Konica Minolta Medical Imaging USA, Inc.
2018-04-04	Z-1214-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter	Konica Minolta Medical Imaging USA, Inc.
2018-04-04	Z-1215-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter	Konica Minolta Medical Imaging USA, Inc.
2018-04-04	Z-1216-2018	Class II	The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart…	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1217-2018	Class II	IMRIS ORT200 Removable Operating Room Table	Deerfield Imaging, Inc.
2018-04-04	Z-1218-2018	Class II	IMRIS ORT300 Removable Operating Room Table	Deerfield Imaging, Inc.
2018-04-04	Z-1219-2018	Class II	(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number:…	DePuy Orthopaedics, Inc.
2018-04-04	Z-1221-2018	Class II	QUANTA-Lyser 240 IFA	Inova Diagnostics Incorporated
2018-04-04	Z-1222-2018	Class II	QUANTA-Lyser 240 EIA	Inova Diagnostics Incorporated
2018-04-04	Z-1223-2018	Class II	Vital-Port Vascular Access System	Cook Vascular Inc.
2018-04-04	Z-1224-2018	Class II	PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R"…	Zimmer Biomet, Inc.
2018-04-04	Z-1225-2018	Class II	ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG	Zimmer Biomet, Inc.
2018-04-04	Z-1226-2018	Class II	ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM…	Zimmer Biomet, Inc.
2018-04-04	Z-1227-2018	Class II	ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC…	Zimmer Biomet, Inc.
2018-04-04	Z-1228-2018	Class II	ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric…	Zimmer Biomet, Inc.
2018-04-04	Z-1229-2018	Class II	ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH…	Zimmer Biomet, Inc.
2018-04-04	Z-1230-2018	Class II	ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL…	Zimmer Biomet, Inc.
2018-04-04	Z-1231-2018	Class II	ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH…	Zimmer Biomet, Inc.
2018-04-04	Z-1232-2018	Class II	ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL…	Zimmer Biomet, Inc.
2018-04-04	Z-1233-2018	Class II	ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW…	Zimmer Biomet, Inc.
2018-04-04	Z-1234-2018	Class II	ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW…	Zimmer Biomet, Inc.
2018-04-04	Z-1235-2018	Class II	ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H…	Zimmer Biomet, Inc.
2018-04-04	Z-1236-2018	Class II	Phoenix Nail System	Zimmer Biomet, Inc.
2018-04-04	Z-1237-2018	Class II	Signia" Power Handle	Covidien LLC
2018-04-04	Z-1238-2018	Class II	Persona Partial Knee spacer block instruments	Zimmer Biomet, Inc.
2018-04-04	Z-1239-2018	Class II	Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML	Zimmer Biomet, Inc.
2018-04-04	Z-1240-2018	Class II	Persona Partial Knee Spacer Blocks To assist in partial knee…	Zimmer Biomet, Inc.
2018-04-04	Z-1241-2018	Class II	AltiVate Reverse INSTRUMENTATION	Encore Medical, Lp
2018-04-04	Z-1242-2018	Class III	Gas Module 3 monitoring spirometer	Mindray DS USA, Inc. dba Mindray North America
2018-04-04	Z-1243-2018	Class II	Break-Away Femoral Nozzle	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1244-2018	Class II	180-Gram Cement Cartridge with Breakaway Femoral Nozzle	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1245-2018	Class II	1	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1246-2018	Class II	1	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1247-2018	Class II	11g Verteport Cement Cannula	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1248-2018	Class II	Advanced Cement Mixing	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1249-2018	Class II	PCD Kit: Long 90	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1250-2018	Class II	1	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1251-2018	Class II	Revolution 90 Degree Tibial Nozzle	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1252-2018	Class II	Revolution CMS w/ Femoral Breakaway Nozzle & Med	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1253-2018	Class II	10g/15mm	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1254-2018	Class II	1	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1255-2018	Class II	Intramedullary Brush Standard O	Stryker Instruments Div. of Stryker Corporation
2018-04-04	Z-1256-2018	Class II	Altivate Anatomic	Encore Medical, Lp
2018-04-04	Z-1257-2018	Class II	Altivate Anatomic	Encore Medical, Lp
2018-04-04	Z-1258-2018	Class II	Altivate Anatomic	Encore Medical, Lp
2018-04-04	Z-1259-2018	Class II	Altivate Anatomic	Encore Medical, Lp
2018-04-04	Z-1260-2018	Class II	Altivate Anatomic	Encore Medical, Lp
2018-04-04	Z-1261-2018	Class II	Syngo	Siemens Medical Solutions USA, Inc
2018-04-04	Z-1262-2018	Class II	F-T3SYSTEM	Allen Medical Systems
2018-04-04	Z-1263-2018	Class II	IMRIS ORT100 Table	Deerfield Imaging, Inc.
2018-04-04	Z-1264-2018	Class II	IMRIS ORT200	Deerfield Imaging, Inc.
2018-04-04	Z-1265-2018	Class II	IMRIS T2X Table	Deerfield Imaging, Inc.
2018-04-04	Z-1266-2018	Class II	IMRIS ORT300	Deerfield Imaging, Inc.
2018-04-04	Z-1267-2018	Class II	EasyCAL HbA1c Calibrator	Medica Corporation
2018-04-04	Z-1268-2018	Class II	c6000	Roche Diagnostics Corporation
2018-04-04	Z-1269-2018	Class II	Modular E 170 Analyzer: Immunoassay Chemistry Analyzer	Roche Diagnostics Corporation
2018-04-04	Z-1270-2018	Class II	cobas e 411 Immunoassay Analyzer	Roche Diagnostics Corporation
2018-04-04	Z-1271-2018	Class II	8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿…	Medical Components, Inc dba MedComp
2018-04-04	Z-1272-2018	Class II	The FEMTO LDV	SIE AG, Surgical Instrument Engineering
2018-04-04	Z-1273-2018	Class II	ProSpore Biological Indicator Part Numbers: PS-6-50	Mesa Laboratories Bozeman Manufacturing Facility
2018-04-04	Z-1274-2018	Class II	SporAmpule Biological Indicator Catalog Number SPS5-100	Mesa Laboratories Bozeman Manufacturing Facility
2018-04-04	Z-1275-2018	Class II	Ray Station 4	RAYSEARCH LABORATORIES AB
2018-03-28	Z-0194-2018	Class I	MONTERIS MEDICAL NEUROBLATE SYSTEM	Monteris Medical Corp
2018-03-28	Z-1075-2018	Class II	Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope	Iridex Corporation
2018-03-28	Z-1076-2018	Class II	GENICON EZEE Retrieval	Genicon, Inc.
2018-03-28	Z-1077-2018	Class II	Epi proColon Plasma Quick Kit	Epigenomics Ag
2018-03-28	Z-1078-2018	Class II	SKIN STAPLE REMOVER	Centurion Medical Products Corporation
2018-03-28	Z-1079-2018	Class II	SUTURE REMOVAL TRAY	Centurion Medical Products Corporation
2018-03-28	Z-1080-2018	Class II	GENERAL PURPOSE INSTRUMENT TRAY	Centurion Medical Products Corporation
2018-03-28	Z-1081-2018	Class II	MINI PLASTICS SET	Centurion Medical Products Corporation
2018-03-28	Z-1082-2018	Class II	CIRCUMCISION TRAY	Centurion Medical Products Corporation
2018-03-28	Z-1083-2018	Class II	CATHETER SECUREMENT SYSTEM	Centurion Medical Products Corporation
2018-03-28	Z-1084-2018	Class II	ST	Centurion Medical Products Corporation
2018-03-28	Z-1085-2018	Class II	SorbaView Shield Dressing Change Tray	Centurion Medical Products Corporation
2018-03-28	Z-1086-2018	Class II	TUBING CHANGE KIT	Centurion Medical Products Corporation
2018-03-28	Z-1087-2018	Class II	MINOR DRESSING CHANGE TRAY	Centurion Medical Products Corporation
2018-03-28	Z-1088-2018	Class II	INCISION & DRAINAGE TRAY or KIT	Centurion Medical Products Corporation
2018-03-28	Z-1089-2018	Class II	BLOOD DRAW KIT	Centurion Medical Products Corporation
2018-03-28	Z-1090-2018	Class II	NEONATAL IV ACCESS SET	Centurion Medical Products Corporation
2018-03-28	Z-1091-2018	Class II	LATEX FREE IV START SET	Centurion Medical Products Corporation
2018-03-28	Z-1092-2018	Class II	PEDIATRIC IV & IV START KIT	Centurion Medical Products Corporation
2018-03-28	Z-1093-2018	Class II	IV START KIT	Centurion Medical Products Corporation
2018-03-28	Z-1094-2018	Class II	INFANT IV SECUREMENT KIT	Centurion Medical Products Corporation
2018-03-28	Z-1095-2018	Class II	NEONATAL IV START KIT	Centurion Medical Products Corporation
2018-03-28	Z-1096-2018	Class II	EXCISION TRAY	Centurion Medical Products Corporation
2018-03-28	Z-1097-2018	Class II	WOUND CARE KIT	Centurion Medical Products Corporation
2018-03-28	Z-1098-2018	Class II	WOUND CLOSURE TRAY	Centurion Medical Products Corporation
2018-03-28	Z-1099-2018	Class II	Malecot Nephrostomy Catheter System	Boston Scientific Corporation
2018-03-28	Z-1100-2018	Class II	Malecot Nephrostomy Catheter Set	Boston Scientific Corporation
2018-03-28	Z-1101-2018	Class II	Malecot Nephrostomy Catheter Set	Boston Scientific Corporation
2018-03-28	Z-1102-2018	Class II	Re-Entry" Malecot Nephrostomy Catheter Set	Boston Scientific Corporation
2018-03-28	Z-1103-2018	Class II	Re-Entry" Malecot Nephrostomy Catheter Set	Boston Scientific Corporation
2018-03-28	Z-1104-2018	Class II	Percutaneous Access Set	Boston Scientific Corporation
2018-03-28	Z-1105-2018	Class II	smith&nephew	Smith & Nephew, Inc.
2018-03-28	Z-1117-2018	Class II	Apex Knee System	OMNIlife science Inc.
2018-03-28	Z-1118-2018	Class II	CATHETER REPAIR KIT	Medical Components, Inc dba MedComp
2018-03-28	Z-1119-2018	Class II	REPAIR KIT	Medical Components, Inc dba MedComp
2018-03-28	Z-1120-2018	Class II	12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR	Medical Components, Inc dba MedComp
2018-03-28	Z-1121-2018	Class II	12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR	Medical Components, Inc dba MedComp
2018-03-28	Z-1122-2018	Class II	12F Tesio CATHETER SET	Medical Components, Inc dba MedComp
2018-03-28	Z-1123-2018	Class II	12F MODIFIED Tesio CATHETER SET	Medical Components, Inc dba MedComp
2018-03-28	Z-1124-2018	Class II	12F Tesio CATHETER SET	Medical Components, Inc dba MedComp
2018-03-28	Z-1125-2018	Class II	TWO PART ADAPTER	Medical Components, Inc dba MedComp
2018-03-28	Z-1126-2018	Class II	CATHETER REPAIR KIT	Medical Components, Inc dba MedComp
2018-03-28	Z-1127-2018	Class II	REPAIR KIT	Medical Components, Inc dba MedComp
2018-03-28	Z-1128-2018	Class II	U2 Total Knee System Tibial Insert	United Orthopedic Corporation
2018-03-28	Z-1129-2018	Class II	U2 Total Knee System Tibial Insert	United Orthopedic Corporation
2018-03-28	Z-1130-2018	Class II	Situate Gauze RF and X-Ray detectable	Covidien LLC
2018-03-28	Z-1131-2018	Class II	Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical…	CooperSurgical, Inc.
2018-03-28	Z-1132-2018	Class II	NxStage PureFlow B Solution	NxStage Medical, Inc.
2018-03-28	Z-1133-2018	Class II	SpyScope DS Access and Delivery diagnostic biliary catheter	Boston Scientific Corporation
2018-03-28	Z-1134-2018	Class II	Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion…	Smiths Medical ASD Inc.
2018-03-28	Z-1135-2018	Class II	Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion…	Smiths Medical ASD Inc.
2018-03-28	Z-1136-2018	Class II	Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion…	Smiths Medical ASD Inc.
2018-03-28	Z-1137-2018	Class II	MyLab Ultrasound System	ESAOTE S.P.A.
2018-03-28	Z-1138-2018	Class II	MyLab Ultrasound System	ESAOTE S.P.A.
2018-03-28	Z-1139-2018	Class I	BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1	Becton Dickinson & Company
2018-03-28	Z-1140-2018	Class I	BD Vacutainer¿ EDTA Tan Top Tube	Becton Dickinson & Company
2018-03-28	Z-1141-2018	Class I	BD Vacutainer¿ EDTA Pink Top Tube	Becton Dickinson & Company
2018-03-28	Z-1142-2018	Class I	BD Vacutainer¿ Lithium Heparin Green Top Tube	Becton Dickinson & Company
2018-03-28	Z-1143-2018	Class II	Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled	Merit Medical Systems, Inc.
2018-03-28	Z-1144-2018	Class II	Custom Dialysis Kit CF-4235 Without Gel	Merit Medical Systems, Inc.
2018-03-28	Z-1145-2018	Class II	Custom Dialysis Kit CF-4230 Without Gel	Merit Medical Systems, Inc.
2018-03-28	Z-1146-2018	Class II	ClariVein IC infusion catheter	Vascular Insights, LLC
2018-03-28	Z-1147-2018	Class II	DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND…	Ethicon, Inc.
2018-03-28	Z-1148-2018	Class II	Artis one fluoroscopic x-ray system and patient table Artis one is an…	Siemens Medical Solutions USA, Inc
2018-03-28	Z-1149-2018	Class II	Wash Kit	Medica Corporation
2018-03-28	Z-1150-2018	Class II	AXIOM Artis angiographic x-ray system	Siemens Medical Solutions USA, Inc
2018-03-28	Z-1151-2018	Class II	AutoMate 2550 "High Speed" Catalog Number ODL25255	Beckman Coulter Inc.
2018-03-28	Z-1152-2018	Class II	ARROWg+ard Blue PLUS catheter	Arrow International Inc
2018-03-28	Z-1153-2018	Class II	J-Plasma Precise	Bovie Medical Corporation
2018-03-28	Z-1154-2018	Class II	J-Plasma Precise	Bovie Medical Corporation
2018-03-28	Z-1155-2018	Class II	J-Plasma	Bovie Medical Corporation
2018-03-28	Z-1156-2018	Class II	J-Plasma Precise 360	Bovie Medical Corporation
2018-03-28	Z-1157-2018	Class II	J-Plasma Precise	Bovie Medical Corporation
2018-03-28	Z-1158-2018	Class II	Percutaneous Sheath Introducer Kit with Integral Hemostasis…	Arrow International Inc
2018-03-28	Z-1159-2018	Class II	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit…	Arrow International Inc
2018-03-28	Z-1160-2018	Class II	Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath	Arrow International Inc
2018-03-28	Z-1161-2018	Class II	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit…	Arrow International Inc
2018-03-28	Z-1162-2018	Class II	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit…	Arrow International Inc
2018-03-28	Z-1163-2018	Class II	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit…	Arrow International Inc
2018-03-28	Z-1164-2018	Class II	Pressure Injectable Two- Lumen Central Venous Catheterization Kit…	Arrow International Inc
2018-03-28	Z-1165-2018	Class II	Pressure Injectable Multi- Lumen CVC Kit	Arrow International Inc
2018-03-28	Z-1166-2018	Class II	ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit	Arrow International Inc
2018-03-28	Z-1167-2018	Class II	SwishTapered Implant Intended for use in support for fixed bridgework	Implant Direct Sybron Manufacturing, LLC
2018-03-28	Z-1168-2018	Class II	SwishPlus Implant Intended for use in support for fixed bridgework	Implant Direct Sybron Manufacturing, LLC
2018-03-28	Z-1169-2018	Class II	AutoMate 1200 Catalog Number ODL25120	Beckman Coulter Inc.
2018-03-21	Z-0933-2018	Class II	Vygon IV Start Convenience Kits	Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
2018-03-21	Z-0934-2018	Class II	Proteus 235	Ion Beam Applications S.A.
2018-03-21	Z-0935-2018	Class II	Difco" Agar Noble	Becton Dickinson & Co.
2018-03-21	Z-0936-2018	Class II	Argyle Suction Tubing	Medtronic Minimally Invasive Therapies Group
2018-03-21	Z-0937-2018	Class II	Liquid Cardiac Control CQ5053	Randox Laboratories, Limited
2018-03-21	Z-0938-2018	Class II	Proteus 235	Ion Beam Applications S.A.
2018-03-21	Z-0939-2018	Class II	Trabecular Metal¿ Primary Hip Prosthesis	Zimmer Biomet, Inc.
2018-03-21	Z-0940-2018	Class II	Accolade and Restoration hip product	Howmedica Osteonics Corp.
2018-03-21	Z-0941-2018	Class II	Accolade and Restoration hip product	Howmedica Osteonics Corp.
2018-03-21	Z-0942-2018	Class II	INFINITY DUAL HEMO MCable Pod	Draegar Medical Systems, Inc.
2018-03-21	Z-0943-2018	Class II	Proteus 235	Ion Beam Applications S.A.
2018-03-21	Z-0944-2018	Class II	ReWalk Personal 6	Argo Medical Technologies Ltd
2018-03-21	Z-0945-2018	Class II	FUTURO	3M Company - Health Care Business
2018-03-21	Z-0946-2018	Class II	ACE	3M Company - Health Care Business
2018-03-21	Z-0947-2018	Class II	Amplatz Extra Stiff Whisker Wire Guide	Cook Inc.
2018-03-21	Z-0948-2018	Class II	Amplatz Extra Stiff Wire Guide	Cook Inc.
2018-03-21	Z-0949-2018	Class II	Amplatz Stiff Wire Guide	Cook Inc.
2018-03-21	Z-0950-2018	Class II	Amplatz Ultra Stiff Wire Guide	Cook Inc.
2018-03-21	Z-0951-2018	Class II	Bentson Cerebral Wire Guide	Cook Inc.
2018-03-21	Z-0952-2018	Class II	Bentson Plus Wire Guide	Cook Inc.
2018-03-21	Z-0953-2018	Class II	Bentson Wire Guide	Cook Inc.
2018-03-21	Z-0954-2018	Class II	Coons Interventional Wire Guide	Cook Inc.
2018-03-21	Z-0955-2018	Class II	Disposable Reuter Tip Deflecting Wire Guide	Cook Inc.
2018-03-21	Z-0956-2018	Class II	Double Flexible Tipped Wire Guide	Cook Inc.
2018-03-21	Z-0957-2018	Class II	Fixed Core Bentson	Cook Inc.
2018-03-21	Z-0958-2018	Class II	Fixed Core Wire Guide	Cook Inc.
2018-03-21	Z-0959-2018	Class II	Movable Core Wire Guide	Cook Inc.
2018-03-21	Z-0960-2018	Class II	Newton Wire Guide	Cook Inc.
2018-03-21	Z-0961-2018	Class II	Reuter Tip Deflecting Wire Guide	Cook Inc.
2018-03-21	Z-0962-2018	Class II	Rosen Curved Wire Guide	Cook Inc.
2018-03-21	Z-0963-2018	Class II	TFE Coated Curved Newton LLT	Cook Inc.
2018-03-21	Z-0964-2018	Class II	Central Venous Catheter Tray	Cook Inc.
2018-03-21	Z-0965-2018	Class II	Left Atrial Catheter Set	Cook Inc.
2018-03-21	Z-0966-2018	Class II	Femoral Artery Pressure Monitoring Set	Cook Inc.
2018-03-21	Z-0967-2018	Class II	SYSTEM 26	ORTHO SOLUTIONS, LTD.
2018-03-21	Z-0968-2018	Class II	BD Vacutainer¿ K2 EDTA	Becton Dickinson & Company
2018-03-21	Z-0969-2018	Class III	Immunoassay Premium Controls	Randox Laboratories
2018-03-21	Z-0970-2018	Class III	Immunoassay Premium Plus Controls	Randox Laboratories

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