Medical device recalls reported in 2020

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Reported	Recall	Class	Product	Firm
2020-03-04	Z-1380-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4	Biomet 3i, LLC
2020-03-04	Z-1381-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4	Biomet 3i, LLC
2020-03-04	Z-1382-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1383-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1384-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1385-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1386-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1387-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1388-2020	Class II	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM	Biomet 3i, LLC
2020-03-04	Z-1389-2020	Class III	LivaNova SMART PERFUSION PACK INSPIRE 8S	LivaNova USA Inc.
2020-03-04	Z-1390-2020	Class III	Getinge 46-Series Washer Disinfector Model # 46-4	Maquet Cardiovascular Us Sales, Llc
2020-03-04	Z-1391-2020	Class III	Getinge 46-Series Washer Disinfector Model # 46-4	Maquet Cardiovascular Us Sales, Llc
2020-03-04	Z-1392-2020	Class II	MicroVention Terumo HydroSoft 10	Microvention, Inc.
2020-03-04	Z-1393-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-03-04	Z-1394-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-03-04	Z-1395-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-03-04	Z-1396-2020	Class II	MicroVention Terumo Microplex 18	Microvention, Inc.
2020-03-04	Z-1397-2020	Class II	MicroVention Terumo Microplex 18	Microvention, Inc.
2020-03-04	Z-1398-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-03-04	Z-1399-2020	Class II	MicroVention Terumo Microplex 18	Microvention, Inc.
2020-03-04	Z-1400-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-03-04	Z-1401-2020	Class II	MicroVention Terumo Microplex 18	Microvention, Inc.
2020-03-04	Z-1402-2020	Class II	MicroVention Terumo HydroFrame 10	Microvention, Inc.
2020-03-04	Z-1403-2020	Class II	MicroVention Terumo HydroFrame 18	Microvention, Inc.
2020-03-04	Z-1404-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-03-04	Z-1405-2020	Class II	MicroVention Terumo HydroSoft 10	Microvention, Inc.
2020-03-04	Z-1406-2020	Class II	MicroVention Terumo Microplex	Microvention, Inc.
2020-03-04	Z-1407-2020	Class II	MicroVention Terumo Microplex 10	Microvention, Inc.
2020-02-26	Z-0942-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0943-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0944-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0945-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0946-2020	Class I	Garbin EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0947-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0948-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0949-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0950-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0951-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0952-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0953-2020	Class I	Trilogy EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-0954-2020	Class I	LifeVent EVO Ventilator	Philips Respironics, Inc.
2020-02-26	Z-1128-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1129-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1130-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1131-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1132-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1133-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1134-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1135-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1136-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1137-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1138-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1139-2020	Class I	NC TREK Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1140-2020	Class I	NC TRAVELER Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1141-2020	Class I	NC TRAVELER Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1142-2020	Class I	NC TRAVELER Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1143-2020	Class I	NC TRAVELER Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1144-2020	Class I	NC TRAVELER Coronary Dilatation Catheter	Abbott Vascular
2020-02-26	Z-1230-2020	Class II	ADVIA Chemistry Enzymatic Creatinine	Siemens Healthcare Diagnostics, Inc.
2020-02-26	Z-1231-2020	Class II	Atellica CH Enzymatic Creatinine	Siemens Healthcare Diagnostics, Inc.
2020-02-26	Z-1232-2020	Class II	Dimension Enzymatic Creatinine	Siemens Healthcare Diagnostics, Inc.
2020-02-26	Z-1233-2020	Class II	Dimension Vista Enzymatic Creatinine	Siemens Healthcare Diagnostics, Inc.
2020-02-26	Z-1234-2020	Class II	Medicrea International Universal Counter Torque for use with the Pass…	Medicrea International
2020-02-26	Z-1235-2020	Class II	Presource Procedure Packs containing AAMI Level 3 surgical gowns	Cardinal Health 200, LLC
2020-02-26	Z-1236-2020	Class II	Arrow FlexTip Plus	Arrow International Inc
2020-02-26	Z-1237-2020	Class II	Arrow FlexTip Plus	Arrow International Inc
2020-02-26	Z-1238-2020	Class II	Arrow FlexTip Plus	Arrow International Inc
2020-02-26	Z-1239-2020	Class II	Arrow FlexTip Plus	Arrow International Inc
2020-02-26	Z-1240-2020	Class II	Arrow Maximal Barrier Drape ASK-00002-1A	Arrow International Inc
2020-02-26	Z-1241-2020	Class II	Arrow StimuCath	Arrow International Inc
2020-02-26	Z-1242-2020	Class II	Arrow PSI Kit for use with 7	Arrow International Inc
2020-02-26	Z-1243-2020	Class II	Arrow Central Venous Catheterization Kit ASK-04200-UPM	Arrow International Inc
2020-02-26	Z-1244-2020	Class II	Arrow EPIDURAL NEEDLE COMPONENT AN-05505	Arrow International Inc
2020-02-26	Z-1245-2020	Class II	Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000	Arrow International Inc
2020-02-26	Z-1246-2020	Class II	Arrow EPIDURAL CATHETERIZATION KIT YC-02220	Arrow International Inc
2020-02-26	Z-1247-2020	Class II	Arrow EPIDURAL CATHETERIZATION KIT JH-05500	Arrow International Inc
2020-02-26	Z-1248-2020	Class II	Arrow EPIDURAL CATHETERIZATION KIT AM-05500	Arrow International Inc
2020-02-26	Z-1249-2020	Class II	Arrow EPIDURAL CATHETERIZATION KIT CK-02220	Arrow International Inc
2020-02-26	Z-1250-2020	Class II	Arrow SPINAL ANESTHESIA SET ASA-25090-S	Arrow International Inc
2020-02-26	Z-1251-2020	Class II	Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000	Arrow International Inc
2020-02-26	Z-1252-2020	Class II	Arrow EPIDURAL NEEDLE KIT SL-05500	Arrow International Inc
2020-02-26	Z-1253-2020	Class II	(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2)…	Arrow International Inc
2020-02-26	Z-1254-2020	Class II	PICC Set- PR-35052-HPHNM	Arrow International Inc
2020-02-26	Z-1255-2020	Class II	Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr	Arrow International Inc
2020-02-26	Z-1256-2020	Class II	EDAN Telemetry Transmitter	Edan Diagnostics
2020-02-26	Z-1257-2020	Class II	SnapLink	Ormco/Sybronendo
2020-02-26	Z-1258-2020	Class II	SnapLink	Ormco/Sybronendo
2020-02-26	Z-1259-2020	Class III	HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS…	Advanced Bionics, LLC
2020-02-26	Z-1260-2020	Class II	ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein	Siemens Healthcare Diagnostics, Inc.
2020-02-26	Z-1261-2020	Class II	Atellica CH High Sensitivity C-Reactive Protein	Siemens Healthcare Diagnostics, Inc.
2020-02-26	Z-1262-2020	Class II	i-STAT CHEM8+ cartridges	Abbott Point Of Care Inc.
2020-02-26	Z-1263-2020	Class II	i-STAT CG4+ cartridge	Abbott Point Of Care Inc.
2020-02-26	Z-1264-2020	Class II	Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection	COVIDIEN LLC
2020-02-26	Z-1265-2020	Class II	i-STAT G3+ cartridge	Abbott Point Of Care Inc.
2020-02-26	Z-1266-2020	Class III	TLC-2000 Therapeutic Medical Laser System	Theralase Inc.
2020-02-26	Z-1267-2020	Class II	Pentax Video Colonoscope Model: EC34-i10L	Pentax of America Inc
2020-02-26	Z-1268-2020	Class II	Pentax Video Colonoscope Model: EC38-i10L	Pentax of America Inc
2020-02-26	Z-1269-2020	Class II	Pilling Aortic Punch	TELEFLEX MEDICAL INC
2020-02-26	Z-1270-2020	Class II	Teleflex Medical Disposable Aortic Punch	TELEFLEX MEDICAL INC
2020-02-26	Z-1271-2020	Class II	Philips HeartStart FRx AED	Philips North America LLC
2020-02-26	Z-1272-2020	Class II	Philips HeartStart HS1 Onsite	Philips North America LLC
2020-02-26	Z-1273-2020	Class II	TwinFix Ti 2	Smith & Nephew, Inc.
2020-02-26	Z-1274-2020	Class II	Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24	Covidien LLC
2020-02-26	Z-1275-2020	Class II	Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11	Covidien LLC
2020-02-26	Z-1276-2020	Class II	Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21	Covidien LLC
2020-02-26	Z-1277-2020	Class II	Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11	Covidien LLC
2020-02-26	Z-1278-2020	Class II	Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22	Covidien LLC
2020-02-26	Z-1279-2020	Class II	Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23	Covidien LLC
2020-02-26	Z-1280-2020	Class II	Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24	Covidien LLC
2020-02-26	Z-1281-2020	Class II	Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24	Covidien LLC
2020-02-26	Z-1282-2020	Class II	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24	Covidien LLC
2020-02-26	Z-1283-2020	Class II	Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21	Covidien LLC
2020-02-26	Z-1284-2020	Class II	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21	Covidien LLC
2020-02-26	Z-1285-2020	Class II	Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21	Covidien LLC
2020-02-26	Z-1286-2020	Class II	Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20	Covidien LLC
2020-02-26	Z-1287-2020	Class II	Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20	Covidien LLC
2020-02-26	Z-1288-2020	Class II	Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30	Covidien LLC
2020-02-26	Z-1289-2020	Class II	Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20	Covidien LLC
2020-02-26	Z-1290-2020	Class II	Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20	Covidien LLC
2020-02-26	Z-1291-2020	Class II	Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A	Covidien LLC
2020-02-26	Z-1292-2020	Class II	Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A	Covidien LLC
2020-02-26	Z-1293-2020	Class II	Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10	Covidien LLC
2020-02-26	Z-1294-2020	Class II	Polysorb Braided Absorbable Suture UD 3/0 30 P-14	Covidien LLC
2020-02-26	Z-1295-2020	Class II	Polysorb Braided Absorbable Suture UD 4/0 18 P-13	Covidien LLC
2020-02-26	Z-1296-2020	Class II	Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K	Covidien LLC
2020-02-26	Z-1297-2020	Class II	Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23	Covidien LLC
2020-02-26	Z-1298-2020	Class II	Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46	Covidien LLC
2020-02-26	Z-1299-2020	Class II	Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46	Covidien LLC
2020-02-26	Z-1300-2020	Class II	Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23	Covidien LLC
2020-02-26	Z-1301-2020	Class II	Presource Procedure Packs containing AAMI Level 3 surgical gowns	Cardinal Health 200, LLC
2020-02-26	Z-1302-2020	Class II	Guided Start Drills/Counterbore NobRpl NP	Nobel Biocare Usa Llc
2020-02-26	Z-1303-2020	Class II	Drill Tapered NP 3	Nobel Biocare Usa Llc
2020-02-26	Z-1304-2020	Class II	Dense Bone Drill 6	Nobel Biocare Usa Llc
2020-02-26	Z-1305-2020	Class II	Screw Tap Tapered WP Single-Pat	Nobel Biocare Usa Llc
2020-02-26	Z-1306-2020	Class II	Drill Tapered NP 3	Nobel Biocare Usa Llc
2020-02-26	Z-1307-2020	Class II	Drill Tapered NP 3	Nobel Biocare Usa Llc
2020-02-26	Z-1308-2020	Class II	Drill Tapered RP 4	Nobel Biocare Usa Llc
2020-02-26	Z-1309-2020	Class II	Drill Tapered RP 4	Nobel Biocare Usa Llc
2020-02-26	Z-1310-2020	Class II	Drill Tapered RP 4	Nobel Biocare Usa Llc
2020-02-26	Z-1311-2020	Class II	Drill Tapered WP 5x10 mm Single-Pat	Nobel Biocare Usa Llc
2020-02-26	Z-1312-2020	Class II	Drill Tapered WP 5x11	Nobel Biocare Usa Llc
2020-02-26	Z-1313-2020	Class II	Drill Tapered 6	Nobel Biocare Usa Llc
2020-02-26	Z-1314-2020	Class II	Dense Bone Drill NP 3	Nobel Biocare Usa Llc
2020-02-26	Z-1315-2020	Class II	Dense Bone Drill WP 5x13 mm Single-Pat	Nobel Biocare Usa Llc
2020-02-26	Z-1316-2020	Class II	Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm	Nobel Biocare Usa Llc
2020-02-26	Z-1317-2020	Class II	Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm	Nobel Biocare Usa Llc
2020-02-26	Z-1318-2020	Class II	Implant Retrieval Instrument CC 3	Nobel Biocare Usa Llc
2020-02-26	Z-1319-2020	Class II	Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm	Nobel Biocare Usa Llc
2020-02-26	Z-1320-2020	Class II	Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm	Nobel Biocare Usa Llc
2020-02-26	Z-1321-2020	Class II	Implant Retrieval Instrument Tri Channel 6	Nobel Biocare Usa Llc
2020-02-26	Z-1322-2020	Class II	Abutment Screw Retrieval Instrument 3	Nobel Biocare Usa Llc
2020-02-26	Z-1323-2020	Class II	Implant Retrieval Kit	Nobel Biocare Usa Llc
2020-02-26	Z-1324-2020	Class II	Abutment Screw Retrieval Kit	Nobel Biocare Usa Llc
2020-02-26	Z-1325-2020	Class II	Abutment Screw Retrieval Instrument RP/WP/6	Nobel Biocare Usa Llc
2020-02-26	Z-1326-2020	Class III	TLC-2000 Therapeutic Medical Laser System	Theralase Inc.
2020-02-26	Z-1327-2020	Class II	OPTILITE IgM Kit	The Binding Site Group, Ltd.
2020-02-26	Z-1328-2020	Class II	CombiDiagnost GCF	Philips Medical Systems Gmbh, DMC
2020-02-26	Z-1329-2020	Class II	CombiDiagnost PCF	Philips Medical Systems Gmbh, DMC
2020-02-26	Z-1330-2020	Class II	DP-30 Digital Ultrasonic Diagnostic Imaging System	Mindray DS USA, Inc. dba Mindray North America
2020-02-26	Z-1331-2020	Class II	Luminos dRF Max	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1332-2020	Class II	Luminos Agile Max	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1333-2020	Class II	Uroskop Omnia max	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1334-2020	Class II	1 STRATAFIX Spiral PDS Plus Violet 18"	Ethicon, Inc.
2020-02-26	Z-1335-2020	Class II	1 STRATAFIX" Spiral PDS Plus Violet 36"	Ethicon, Inc.
2020-02-26	Z-1336-2020	Class II	1 STRATAFIX" Spiral PDS Plus Violet 12"	Ethicon, Inc.
2020-02-26	Z-1337-2020	Class II	Luminos dRF Max	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1338-2020	Class II	Luminos Agile Max	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1339-2020	Class II	Ysio Max	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1340-2020	Class II	ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number:…	Siemens Medical Solutions USA, Inc
2020-02-26	Z-1341-2020	Class II	UST-2265-2 Probe	Hitachi Medical Systems America Inc
2020-02-19	Z-0930-2020	Class I	PneumoDart	Tytek Medical Inc
2020-02-19	Z-0955-2020	Class I	Medtronic MiniMed 630G System with SmartGuard	Medtronic Inc.
2020-02-19	Z-0956-2020	Class I	Medtronic MiniMed 670G System with SmartGuard	Medtronic Inc.
2020-02-19	Z-0957-2020	Class I	Medtronic MiniMed 620G Insulin Infusion Pump	Medtronic Inc.
2020-02-19	Z-0958-2020	Class I	Medtronic MiniMed 640G Insulin Infusion Pump	Medtronic Inc.
2020-02-19	Z-1103-2020	Class II	fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush…	Fridababy LLC
2020-02-19	Z-1104-2020	Class II	Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677…	Dexcom Inc
2020-02-19	Z-1106-2020	Class II	TandemLife ECLS Procedure Kit	Cardiac Assist, Inc
2020-02-19	Z-1107-2020	Class II	VIDAS Varicella Zoster IgG	bioMerieux, Inc.
2020-02-19	Z-1108-2020	Class II	Terumo Advanced Perfusion System 1 Roller Pump	Terumo Cardiovascular Systems Corporation
2020-02-19	Z-1109-2020	Class II	Terumo Advanced Perfusion System 1 Roller Pump	Terumo Cardiovascular Systems Corporation
2020-02-19	Z-1110-2020	Class II	Terumo Advanced Perfusion Assembly Pump Guts	Terumo Cardiovascular Systems Corporation
2020-02-19	Z-1111-2020	Class II	Terumo Advanced Perfusion Assembly Pump Guts	Terumo Cardiovascular Systems Corporation
2020-02-19	Z-1112-2020	Class I	HUDSON RCI COMFORT FLO Corrugated Humidification System	TELEFLEX MEDICAL INC
2020-02-19	Z-1113-2020	Class I	HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote…	TELEFLEX MEDICAL INC
2020-02-19	Z-1114-2020	Class I	HUDSON RCI COMFORT FLO Humidification System	TELEFLEX MEDICAL INC
2020-02-19	Z-1115-2020	Class I	HUDSON RCI COMFORT FLO Humidification System With Remote Temperature…	TELEFLEX MEDICAL INC
2020-02-19	Z-1116-2020	Class II	Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic…	TELEFLEX MEDICAL INC
2020-02-19	Z-1117-2020	Class II	Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic…	TELEFLEX MEDICAL INC
2020-02-19	Z-1118-2020	Class II	VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800…	LivaNova USA Inc
2020-02-19	Z-1119-2020	Class III	LivaNova Sorin Connect DPIII KOMPL	LivaNova USA Inc.
2020-02-19	Z-1120-2020	Class II	Prometra Programmable 20mL Pump	Flowonix Medical Inc
2020-02-19	Z-1121-2020	Class II	Prometra II 20mL Pump	Flowonix Medical Inc
2020-02-19	Z-1122-2020	Class II	Prometra II 40mL Pump	Flowonix Medical Inc
2020-02-19	Z-1123-2020	Class II	US Clinical 20mL Programmable Pump	Flowonix Medical Inc
2020-02-19	Z-1124-2020	Class II	Prometra Programmable 20mL Pump	Flowonix Medical Inc
2020-02-19	Z-1125-2020	Class II	Prometra II Programmable 20mL Pump	Flowonix Medical Inc
2020-02-19	Z-1126-2020	Class II	SwishPlus Implant 5	Implant Direct Sybron Manufacturing LLC
2020-02-19	Z-1127-2020	Class II	Stratum Lapidus Plate	Nextremity Solutions
2020-02-19	Z-1145-2020	Class II	VesselNavigator application used with Philips Azurion	Philips North America, LLC

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