Medical device recalls reported in 2021

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Reported	Recall	Class	Product	Firm
2021-04-28	Z-1481-2021	Class II	Medex 10 IN Pressure Injector Line w/Rot	Smiths Medical ASD Inc.
2021-04-28	Z-1482-2021	Class II	ELI 280 Electrocardiograph	Welch Allyn Inc Mortara
2021-04-28	Z-1483-2021	Class II	ELI 380 Electrocardiograph	Welch Allyn Inc Mortara
2021-04-28	Z-1484-2021	Class II	Surveyor S12/S19 Bedside Patient Monitor	Welch Allyn Inc Mortara
2021-04-28	Z-1485-2021	Class II	AM12M Acquisition Module accessory	Welch Allyn Inc Mortara
2021-04-21	Z-1380-2021	Class II	Tibial Opening Wedge Osteotomy Plate	Arthrex, Inc.
2021-04-21	Z-1381-2021	Class II	VGlove NITRILE *** Protect Your Life 100 Patient examination gloves	HUBO INTERNATIONAL INC
2021-04-21	Z-1382-2021	Class II	SUNSTAR Butler Clear Dip	Sunstar Americas, Inc.
2021-04-21	Z-1383-2021	Class II	Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm…	Covidien, LP
2021-04-21	Z-1384-2021	Class II	Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30…	Covidien, LP
2021-04-21	Z-1385-2021	Class II	Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm…	Covidien, LP
2021-04-21	Z-1386-2021	Class II	ADVIA 2120 with Single Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1387-2021	Class II	ADVIA 2120 Dual Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1388-2021	Class II	ADVIA 2120 REFURB SAA AUTOSAMPLER	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1389-2021	Class II	ADVIA 2120 REFURB DAA AUTOSAMPLER	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1390-2021	Class II	ADVIA 2120i with Single Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1391-2021	Class II	ADVIA 2120i Dual Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1392-2021	Class II	ADVIA 2120i Refurb Single Aspirate	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1393-2021	Class II	ADVIA 2120i Refurb Dual Aspirate	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1394-2021	Class II	ADVIA 2120i	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1395-2021	Class II	ADVIA 2120i	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1396-2021	Class II	ADVIA 2120 with Single Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1397-2021	Class II	ADVIA 2120 Dual Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1398-2021	Class II	ADVIA 2120 REFURB SAA AUTOSAMPLER	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1399-2021	Class II	ADVIA 2120 REFURB DAA AUTOSAMPLER	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1400-2021	Class II	ADVIA 2120i with Single Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1401-2021	Class II	ADVIA 2120i Dual Aspirate Autosampler	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1402-2021	Class II	ADVIA 2120i Refurb Single Aspirate	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1403-2021	Class II	ADVIA 2120i Refurb Dual Aspirate	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1404-2021	Class II	ADVIA 2120i	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1405-2021	Class II	ADVIA 2120i	Siemens Healthcare Diagnostics, Inc.
2021-04-21	Z-1406-2021	Class II	Prodisc C	Centinel Spine, Inc.
2021-04-21	Z-1407-2021	Class II	Diluent	Medline Industries Inc
2021-04-21	Z-1408-2021	Class II	VIDAS¿ CMV IgM 30 Tests	Biomerieux Inc
2021-04-21	Z-1409-2021	Class III	Evolve Cell Culture Bags	OriGen Biomedical, Inc.
2021-04-21	Z-1410-2021	Class II	Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw…	K2M, Inc
2021-04-21	Z-1411-2021	Class II	Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical	Covidien
2021-04-21	Z-1412-2021	Class II	¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit	Fujifilm Medical Systems U.S.A., Inc.
2021-04-21	Z-1413-2021	Class II	cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents	Roche Molecular Systems, Inc.
2021-04-21	Z-1414-2021	Class II	cobas Liat Analyzer: respiratory virus panel nucleic acid assay…	Roche Molecular Systems, Inc.
2021-04-21	Z-1415-2021	Class II	The EOSedge system may acquire two simultaneous orthogonal planar…	EOS Imaging
2021-04-21	Z-1416-2021	Class II	BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for…	Becton Dickinson & Co.
2021-04-21	Z-1417-2021	Class II	MedSchenker Smart Transport Medium	Vectornate USA Inc
2021-04-21	Z-1419-2021	Class II	Covidien Tri-Staple 2	Covidien Llc
2021-04-21	Z-1420-2021	Class II	Disposable Sampling Tube	Krishe Inc
2021-04-21	Z-1421-2021	Class II	Dasky Disposable Sampling Tube	Krishe Inc
2021-04-21	Z-1422-2021	Class II	Dasky Disposable Sampling Tube	Krishe Inc
2021-04-21	Z-1423-2021	Class II	Dasky Disposable Sampling Tube	Krishe Inc
2021-04-21	Z-1424-2021	Class II	Remel Haemophilus Test Medium	Remel Inc
2021-04-21	Z-1425-2021	Class II	Remel Haemophilus Test Medium	Remel Inc
2021-04-21	Z-1427-2021	Class II	RayStation Model Number:	RAYSEARCH LABORATORIES AB
2021-04-21	Z-1428-2021	Class II	Stryker	Stryker Corporation
2021-04-21	Z-1429-2021	Class II	MAMBA Flex 135 Microcatheter	Boston Scientific Corporation
2021-04-21	Z-1430-2021	Class II	MAMBA Microcatheter	Boston Scientific Corporation
2021-04-14	Z-1331-2021	Class I	Alaris Infusion Pump Module	Tenacore LLC
2021-04-14	Z-1332-2021	Class I	Alaris Infusion Pump 8100 Bezel	Tenacore LLC
2021-04-14	Z-1336-2021	Class I	Medtronic HVAD Controller	Heartware, Inc.
2021-04-14	Z-1337-2021	Class I	Power Supply: 1	Heartware, Inc.
2021-04-14	Z-1338-2021	Class I	Medtronic HVAD Alarm Adapter	Heartware, Inc.
2021-04-14	Z-1339-2021	Class I	Medtronic HVAD Monitor Data Cable	Heartware, Inc.
2021-04-14	Z-1340-2021	Class I	Medtronic HVAD Battery	Heartware, Inc.
2021-04-14	Z-1341-2021	Class I	Medtronic HVAD Packaged Monitor	Heartware, Inc.
2021-04-14	Z-1343-2021	Class II	Amicus MNC Apheresis Kit	Fenwal Inc
2021-04-14	Z-1344-2021	Class II	Amicus Exchange Kit	Fenwal Inc
2021-04-14	Z-1345-2021	Class II	Amicus Exchange Kit Therapeutics	Fenwal Inc
2021-04-14	Z-1346-2021	Class II	Ysio X	Siemens Medical Solutions USA, Inc
2021-04-14	Z-1347-2021	Class II	Enteral Infusion Pump	Cardinal Health 200, LLC
2021-04-14	Z-1348-2021	Class II	Synapse PACS	Fujifilm Medical Systems U.S.A., Inc.
2021-04-14	Z-1349-2021	Class II	NUVASIVE PRECICE Intramedullary Limb Lengthening	Nuvasive Specialized Orthopedics Inc
2021-04-14	Z-1350-2021	Class II	NUVASIVE PRECICE UNYTE System	Nuvasive Specialized Orthopedics Inc
2021-04-14	Z-1351-2021	Class II	NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening…	Nuvasive Specialized Orthopedics Inc
2021-04-14	Z-1352-2021	Class II	EXTREME H2O 59%	Clerio Vision
2021-04-14	Z-1353-2021	Class II	Drop Arm Versamode"	Gf Health Products
2021-04-14	Z-1354-2021	Class II	CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe…	Integra LifeSciences Corp.
2021-04-14	Z-1355-2021	Class II	At Home Artificial Intrauterine Insemination Kit	Tenderneeds Fertility LLC
2021-04-14	Z-1356-2021	Class II	At Home Semi-Flex/Rigid Insemination Device	Tenderneeds Fertility LLC
2021-04-14	Z-1357-2021	Class II	At Home Artificial Intrauterine Insemination Flex Set	Tenderneeds Fertility LLC
2021-04-14	Z-1358-2021	Class II	Deluxe At Home Pro Series Insemination Kit	Tenderneeds Fertility LLC
2021-04-14	Z-1359-2021	Class II	Deluxe At Home Artificial Insemination Kit	Tenderneeds Fertility LLC
2021-04-14	Z-1360-2021	Class II	Premium At Home Pro Series Insemination Kit	Tenderneeds Fertility LLC
2021-04-14	Z-1361-2021	Class II	Professional Artificial Intrauterine Insemination Kit	Tenderneeds Fertility LLC
2021-04-14	Z-1362-2021	Class II	Professional Clinical Artificial Intrauterine Insemination Kit	Tenderneeds Fertility LLC
2021-04-14	Z-1363-2021	Class II	Pro Series Fertility Device	Tenderneeds Fertility LLC
2021-04-14	Z-1364-2021	Class II	Professional At Home Artificial Intrauterine Insemination Set	Tenderneeds Fertility LLC
2021-04-14	Z-1366-2021	Class II	SHARP MEDICAL PRODUCTS	Sharp Medical Products
2021-04-14	Z-1367-2021	Class II	Consist of a distal connection mechanism	Terumo Cardiovascular Systems Corporation
2021-04-14	Z-1368-2021	Class II	A610 Clinician Programmer Application for Deep Brain Stimulation…	Medtronic Neuromodulation
2021-04-14	Z-1369-2021	Class II	Panther Fusion Tube Tray	Hologic, Inc
2021-04-14	Z-1370-2021	Class II	MicroScan WalkAway-40 plus Instrument	Beckman Coulter Inc.
2021-04-14	Z-1371-2021	Class II	MicroScan WalkAway-96 plus Instrument	Beckman Coulter Inc.
2021-04-14	Z-1372-2021	Class II	MicroScan WalkAway-40 plus Reconditioned Instrument	Beckman Coulter Inc.
2021-04-14	Z-1373-2021	Class II	MicroScan WalkAway-96 plus Reconditioned Instrument	Beckman Coulter Inc.
2021-04-14	Z-1374-2021	Class II	Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13…	Arrow International Inc
2021-04-14	Z-1376-2021	Class II	Regard	ROi CPS LLC
2021-04-14	Z-1377-2021	Class II	BD BBL Martin-Lewis Agar	Becton Dickinson & Co.
2021-04-14	Z-1378-2021	Class II	BD BBL Martin-Lewis Agar 20 Ea	Becton Dickinson & Co.
2021-04-14	Z-1379-2021	Class II	Trial Cutting Guide for Triathlon Total Knee System	Howmedica Osteonics Corp.
2021-04-07	Z-1258-2021	Class I	ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge…	Smisson-Cartledge Biomedical, LLC
2021-04-07	Z-1259-2021	Class I	ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge…	Smisson-Cartledge Biomedical, LLC
2021-04-07	Z-1260-2021	Class I	ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge…	Smisson-Cartledge Biomedical, LLC
2021-04-07	Z-1305-2021	Class I	Implantable cardioverter defibrillators	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-04-07	Z-1306-2021	Class I	Implantable cardioverter defibrillators	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-04-07	Z-1309-2021	Class I	BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad	CareFusion 303, Inc.
2021-04-07	Z-1310-2021	Class II	Drill Bit	Arthrex, Inc.
2021-04-07	Z-1311-2021	Class II	Vertical Drain Tube Attachment Device	Hollister Incorporated
2021-04-07	Z-1312-2021	Class II	Coronavirus antigen detection test system	LumiraDx
2021-04-07	Z-1313-2021	Class I	Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console	Medtronic Perfusion Systems
2021-04-07	Z-1314-2021	Class II	ATTUNE¿ FIXED BEARING KNEE	DePuy Orthopaedics, Inc.
2021-04-07	Z-1315-2021	Class II	The LCS COMPLETE P	DePuy Orthopaedics, Inc.
2021-04-07	Z-1316-2021	Class II	The ATTUNE¿ Rotating Platform	DePuy Orthopaedics, Inc.
2021-04-07	Z-1317-2021	Class II	EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation…	EPIX THERAPEUTICS, INC
2021-04-07	Z-1318-2021	Class II	EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation…	EPIX THERAPEUTICS, INC
2021-04-07	Z-1319-2021	Class II	EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation…	EPIX THERAPEUTICS, INC
2021-04-07	Z-1320-2021	Class II	EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation…	EPIX THERAPEUTICS, INC
2021-04-07	Z-1321-2021	Class II	EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter	EPIX THERAPEUTICS, INC
2021-04-07	Z-1322-2021	Class II	EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter	EPIX THERAPEUTICS, INC
2021-04-07	Z-1323-2021	Class II	PRECICE STRYDE	Nuvasive Specialized Orthopedics Inc
2021-04-07	Z-1324-2021	Class II	Precice Bone Transport	Nuvasive Specialized Orthopedics Inc
2021-04-07	Z-1325-2021	Class II	PRECICE PLATE	Nuvasive Specialized Orthopedics Inc
2021-04-07	Z-1326-2021	Class II	Philips SureSigns VM4	Philips North America, LLC
2021-04-07	Z-1327-2021	Class II	Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery	Stryker Sustainability Solutions
2021-04-07	Z-1328-2021	Class II	Alcon Custom Ophthalmic Surgical Procedure Packs	Alcon Research, LLC
2021-04-07	Z-1329-2021	Class II	AngioDynamics SafeSheath ULTRALITE 10F	Oscor, Inc.
2021-04-07	Z-1330-2021	Class II	Product Label	Siemens Medical Solutions USA, Inc.
2021-04-07	Z-1333-2021	Class II	BIOCARE Medical	Biocare Medical, LLC
2021-04-07	Z-1334-2021	Class II	CF Delivery Dev Caps Bravo x5	Covidien Llc
2021-04-07	Z-1335-2021	Class II	BRAVO PH CAPS DELIVERY DEV5-PK	Covidien Llc
2021-04-07	Z-1342-2021	Class II	LIAISON 1-84 PTH Assay	Diasorin Inc.
2021-03-31	Z-1277-2021	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2021-03-31	Z-1278-2021	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2021-03-31	Z-1279-2021	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2021-03-31	Z-1280-2021	Class II	Preventative Maintenance Kits G5010007) and spare part kits	Baxter Healthcare Corporation
2021-03-31	Z-1281-2021	Class II	RayCare 3B	RAYSEARCH LABORATORIES AB
2021-03-31	Z-1282-2021	Class II	Ultrasonic pulsed doppler imaging system	Hitachi Medical Systems America Inc
2021-03-31	Z-1283-2021	Class II	In2Bones Shannon Percutaneous Burr	In2Bones, SAS
2021-03-31	Z-1284-2021	Class II	CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN *****	CAIRE DIAGNOSTICS INC
2021-03-31	Z-1285-2021	Class II	Biosense Webster	Biosense Webster, Inc.
2021-03-31	Z-1286-2021	Class II	Biosense Webster	Biosense Webster, Inc.
2021-03-31	Z-1287-2021	Class II	Biosense Webster	Biosense Webster, Inc.
2021-03-31	Z-1288-2021	Class II	Interventional Fluoroscopic X-Ray System	Siemens Medical Solutions USA, Inc
2021-03-31	Z-1289-2021	Class II	BARD MARQUEE Disposable Core Biopsy Instruments XX	Bard Peripheral Vascular Inc
2021-03-31	Z-1290-2021	Class II	Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER	Corin Ltd
2021-03-31	Z-1291-2021	Class II	Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER	Corin Ltd
2021-03-31	Z-1292-2021	Class II	Duodenoscope and accessories	Olympus Corporation of the Americas
2021-03-31	Z-1293-2021	Class II	Mizuho CE IPX4	Mizuho OSI
2021-03-31	Z-1294-2021	Class II	RUSCH¿ POLARIS" Laryngoscope	TELEFLEX MEDICAL INC
2021-03-31	Z-1295-2021	Class II	VITROS Chemistry Products Calibrator Kit 4-	Ortho-Clinical Diagnostics, Inc.
2021-03-31	Z-1296-2021	Class II	Operating Table System	Getinge Group Logistics America, LLC
2021-03-31	Z-1297-2021	Class II	S-Series Equipment Management System	Stryker Communications
2021-03-31	Z-1298-2021	Class II	PLEUR-EVAC Thoracic Catheters	TELEFLEX MEDICAL INC
2021-03-31	Z-1299-2021	Class II	The ImmunoCard Mycoplasma EIA detects the presence of IgM to M	Meridian Bioscience Inc
2021-03-31	Z-1300-2021	Class II	In-View Clear Leggings Sterile	Cardinal Health 200, LLC
2021-03-31	Z-1301-2021	Class II	In-View Clear Leggings Sterile Non-Sterile	Cardinal Health 200, LLC
2021-03-31	Z-1302-2021	Class II	In-View Clear Leggings Bulk Non-Sterile	Cardinal Health 200, LLC
2021-03-31	Z-1303-2021	Class II	Femoral Angiography Drape Sterile	Cardinal Health 200, LLC
2021-03-31	Z-1304-2021	Class II	Femoral Angiography Drape Bulk Non-Sterile	Cardinal Health 200, LLC
2021-03-31	Z-1307-2021	Class II	VITEK 2	Biomerieux Inc
2021-03-31	Z-1308-2021	Class II	VITEK 2 Compact	Biomerieux Inc
2021-03-24	Z-1190-2021	Class I	Medtronic Affinity Pixie Hollow Fiber Oxygenator and…	Medtronic Perfusion Systems
2021-03-24	Z-1191-2021	Class I	Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and…	Medtronic Perfusion Systems
2021-03-24	Z-1192-2021	Class I	Custom Perfusion System	Medtronic Perfusion Systems
2021-03-24	Z-1193-2021	Class I	Medtronic Custom Pack Infant Tubingset Pixie Flow 0	Medtronic Perfusion Systems
2021-03-24	Z-1194-2021	Class I	Medtronic Custom Pack EVNP Clinical with AP40 1/B	Medtronic Perfusion Systems
2021-03-24	Z-1195-2021	Class I	Medtronic Custom Perfusion Pack	Medtronic Perfusion Systems
2021-03-24	Z-1196-2021	Class I	Custom Perfusion System	Medtronic Perfusion Systems
2021-03-24	Z-1197-2021	Class I	Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B	Medtronic Perfusion Systems
2021-03-24	Z-1198-2021	Class I	Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B	Medtronic Perfusion Systems
2021-03-24	Z-1199-2021	Class I	Custom Perfusion System	Medtronic Perfusion Systems
2021-03-24	Z-1249-2021	Class II	RNA MEDICAL	Medline Industries Inc
2021-03-24	Z-1250-2021	Class II	Magellan Hypodermic Safety Needle	Cardinal Health 200, LLC
2021-03-24	Z-1251-2021	Class II	McKesson PREVENT M NEEDLE	Cardinal Health 200, LLC
2021-03-24	Z-1252-2021	Class II	Magellan 3 mL Syringe with Hypodermic Safety Needle	Cardinal Health 200, LLC
2021-03-24	Z-1253-2021	Class II	Software versions syngo	Siemens Medical Solutions USA, Inc
2021-03-24	Z-1254-2021	Class II	Mindray BeneVision Distributed Monitoring System	Mindray DS USA, Inc. dba Mindray North America
2021-03-24	Z-1255-2021	Class II	Quantikine IVD Human sTfR Immunoassay	R & D Systems, Inc.
2021-03-24	Z-1256-2021	Class II	JUDKINS PACK	Cardinal Health 200, LLC
2021-03-24	Z-1257-2021	Class I	PRECISE PRO RX CAROTID STENT implant system	Cordis Corporation
2021-03-24	Z-1262-2021	Class II	HeartSpan Transseptal Needles Catalog No	Merit Medical Systems, Inc.
2021-03-24	Z-1263-2021	Class II	Heartspan Transseptal Needles	Merit Medical Systems, Inc.
2021-03-24	Z-1264-2021	Class II	Impactis NaviKit-stereotaxic accessory for Computed Tomography…	Imactis
2021-03-24	Z-1265-2021	Class II	Incisive CT Computed Tomography X-ray System Model: 728143	Philips North America Llc
2021-03-24	Z-1266-2021	Class II	VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro…	Ortho-Clinical Diagnostics, Inc.
2021-03-24	Z-1267-2021	Class II	VITROS SARS-CoV-2 Antigen Reagent Pack	Ortho-Clinical Diagnostics, Inc.
2021-03-24	Z-1268-2021	Class II	Carestream Dental CS 3600 Single Use Normal Tips	CARESTREAM DENTAL, LLC
2021-03-24	Z-1269-2021	Class II	Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V…	Canon Medical System, USA, INC.
2021-03-24	Z-1270-2021	Class II	Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C…	Canon Medical System, USA, INC.
2021-03-24	Z-1271-2021	Class II	Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F…	Canon Medical System, USA, INC.
2021-03-24	Z-1272-2021	Class II	CyberKnife Treatment Delivery System	Accuray Incorporated
2021-03-24	Z-1273-2021	Class II	Philips CT systems are advanced continuous-rotation computed…	Philips Healthcare (Suzhou) Co., Ltd.
2021-03-24	Z-1274-2021	Class II	Enzyme linked immunosorbent assay	Siemens Healthcare Diagnostics, Inc
2021-03-24	Z-1275-2021	Class II	SIROS D-Vial Prep Set	Sirtex Medical Limited
2021-03-24	Z-1276-2021	Class II	Feth-R-Kath Catheter	Epimed International, Inc.
2021-03-17	Z-1174-2021	Class II	System INFX-8000V	Canon Medical System, USA, INC.
2021-03-17	Z-1175-2021	Class II	System INFX-8000C	Canon Medical System, USA, INC.
2021-03-17	Z-1176-2021	Class II	System INFX-8000F	Canon Medical System, USA, INC.
2021-03-17	Z-1177-2021	Class II	VentStar Anesthesia	Draeger Medical, Inc.
2021-03-17	Z-1178-2021	Class II	VentStar Basic	Draeger Medical, Inc.
2021-03-17	Z-1179-2021	Class II	VentStar Watertrap	Draeger Medical, Inc.
2021-03-17	Z-1180-2021	Class II	ID Circuit Basic	Draeger Medical, Inc.
2021-03-17	Z-1181-2021	Class II	Anesthesia gas-machine	Getinge Group Logistics America, LLC

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