Medical device recalls reported in 2021

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Reported	Recall	Class	Product	Firm
2021-08-18	Z-2241-2021	Class II	Kaluza C Flow Cytometry Software Versions: 1	Beckman Coulter, Inc.
2021-08-18	Z-2242-2021	Class II	smith&nephew BHR SQUARE HEADED NAIL	Smith & Nephew Orthopaedics Ltd. (Aurora)
2021-08-18	Z-2243-2021	Class II	MERITMEDICAL Prelude Short Sheath Introducer	Merit Medical Systems, Inc.
2021-08-18	Z-2245-2021	Class II	FilmArray Blood Culture Identification	BioFire Diagnostics, LLC
2021-08-18	Z-2246-2021	Class II	CUTTING ELECTRODE BIPO 24	Richard Wolf GmbH
2021-08-18	Z-2247-2021	Class II	TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with…	Bard Peripheral Vascular Inc
2021-08-18	Z-2248-2021	Class II	EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with…	Bard Peripheral Vascular Inc
2021-08-18	Z-2249-2021	Class II	TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle…	Bard Peripheral Vascular Inc
2021-08-18	Z-2250-2021	Class II	Exactech BIOLOX delta Femoral Head	Exactech, Inc.
2021-08-18	Z-2251-2021	Class II	Exactech BIOLOX delta Femoral Head	Exactech, Inc.
2021-08-18	Z-2252-2021	Class II	The device is a 25-gauge infusion line that is part of 25-gauge…	Dutch Ophthalmic USA, Inc.
2021-08-18	Z-2253-2021	Class II	Simpleware ScanIP software	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
2021-08-18	Z-2254-2021	Class II	Simpleware ScanIP medical software	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
2021-08-18	Z-2255-2021	Class II	ACCESS SARS-CoV-2 Antigen	Beckman Coulter Inc.
2021-08-18	Z-2256-2021	Class II	Access SARS-CoV-2 Antigen Calibrators	Beckman Coulter Inc.
2021-08-18	Z-2257-2021	Class II	ACCESS SARS-CoV-2 ANTIGEN QC	Beckman Coulter Inc.
2021-08-18	Z-2258-2021	Class II	ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION	Beckman Coulter Inc.
2021-08-18	Z-2259-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2260-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2261-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2262-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2263-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2264-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2265-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2266-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2267-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2268-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2269-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2270-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2271-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2272-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2273-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2274-2021	Class II	Arcos Modular Revision Hip System Standard Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2275-2021	Class II	Arcos Modular Revision Hip System High Offset Cone Prox Body	Biomet, Inc.
2021-08-18	Z-2276-2021	Class II	Alinity s System REF 06P16-01	Abbott Laboratories, Inc
2021-08-18	Z-2277-2021	Class II	Spectrum Medical Quantum Standard heat exchanger	QURA S.R.L.
2021-08-18	Z-2278-2021	Class II	Edwards PediaSat Oximetry Catheter Kit	Edwards Lifesciences, LLC
2021-08-18	Z-2279-2021	Class II	Edwards PediaSat Oximetry Catheter Kit	Edwards Lifesciences, LLC
2021-08-18	Z-2280-2021	Class II	Edwards PediaSat Oximetry Catheter Kit	Edwards Lifesciences, LLC
2021-08-18	Z-2281-2021	Class II	Edwards PediaSat Oximetry Catheter Set	Edwards Lifesciences, LLC
2021-08-18	Z-2282-2021	Class II	Edwards PediaSat Oximetry Catheter Set	Edwards Lifesciences, LLC
2021-08-18	Z-2283-2021	Class II	Edwards PediaSat Oximetry Catheter Set	Edwards Lifesciences, LLC
2021-08-11	Z-2167-2021	Class II	Regard NEWBORN KIT	ROi CPS LLC
2021-08-11	Z-2168-2021	Class II	Regard NEWBORN KIT	ROi CPS LLC
2021-08-11	Z-2169-2021	Class II	Regard NEWBORN KIT	ROi CPS LLC
2021-08-11	Z-2170-2021	Class II	Nail Insertion Sleeve	Stryker GmbH
2021-08-11	Z-2171-2021	Class II	Nail Insertion Sleeve	Stryker GmbH
2021-08-11	Z-2172-2021	Class III	GlideScope Go Monitors	Verathon, Inc.
2021-08-11	Z-2173-2021	Class II	Sharesource Connectivity Platform for Use with the Amia Automated PD…	BAXTER HEALTHCARE CORPORATION
2021-08-11	Z-2174-2021	Class II	Kaguya Automated Peritoneal Dialysis System	BAXTER HEALTHCARE CORPORATION
2021-08-11	Z-2175-2021	Class II	Flex IUI Set with LED Lighted Speculum and Test kit	Tenderneeds Fertility LLC
2021-08-11	Z-2176-2021	Class II	Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation…	Tenderneeds Fertility LLC
2021-08-11	Z-2177-2021	Class II	Premium Human Artificial Intrauterine Insemination	Tenderneeds Fertility LLC
2021-08-11	Z-2178-2021	Class II	Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium	Tenderneeds Fertility LLC
2021-08-11	Z-2179-2021	Class II	2 X Sterile Human Home Artificial Insemination Semen Kit	Tenderneeds Fertility LLC
2021-08-11	Z-2180-2021	Class II	TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits	Tenderneeds Fertility LLC
2021-08-11	Z-2181-2021	Class II	Deluxe At-Home Human Artificial Intracervical	Tenderneeds Fertility LLC
2021-08-11	Z-2182-2021	Class II	Deluxe IntraCervical Insemination	Tenderneeds Fertility LLC
2021-08-11	Z-2183-2021	Class II	2 Complete ICI Human At Home Donor Artificial Insemination Kits…	Tenderneeds Fertility LLC
2021-08-11	Z-2184-2021	Class II	REF: 08P1820	Abbott Laboratories
2021-08-11	Z-2185-2021	Class II	REF 8L92-22	Abbott Laboratories
2021-08-11	Z-2186-2021	Class II	REF 8L92-21	Abbott Laboratories
2021-08-11	Z-2187-2021	Class II	REF 8L92-42	Abbott Laboratories
2021-08-11	Z-2198-2021	Class II	Straumann SCS Screwdriver	Straumann USA LLC
2021-08-11	Z-2199-2021	Class III	Beta-Hydroxybutyrate LiquiColor	Stanbio Laboratory, LP
2021-08-11	Z-2200-2021	Class III	Beta-Hydroxybutyrate Reagent A	Stanbio Laboratory, LP
2021-08-11	Z-2201-2021	Class III	Synchron CX/DX/LX Beta-Hydroxybutyrate	Stanbio Laboratory, LP
2021-08-11	Z-2202-2021	Class III	Cardinal Health Beta-Hydroxybutyrate	Stanbio Laboratory, LP
2021-08-11	Z-2203-2021	Class III	Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX	Stanbio Laboratory, LP
2021-08-04	Z-2005-2021	Class I	Recirculator 8	Eight Medical International BV
2021-08-04	Z-2134-2021	Class II	CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13	Cytocell Ltd.
2021-08-04	Z-2135-2021	Class II	Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II…	Medtronic Vascular, Inc.
2021-08-04	Z-2136-2021	Class II	Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs…	Medtronic Vascular, Inc.
2021-08-04	Z-2137-2021	Class II	Infusomat Space Volumetric Pump Administration Set	B. Braun Medical, Inc.
2021-08-04	Z-2138-2021	Class II	RayStation	RAYSEARCH LABORATORIES AB
2021-08-04	Z-2139-2021	Class II	CARESCAPE PDM-Masimo SpO2	GE Healthcare, LLC
2021-08-04	Z-2140-2021	Class II	Heater Cooler Unit	Maquet Medical Systems USA
2021-08-04	Z-2141-2021	Class II	OxyMask O2 Adult REF OM-1125-14	Southmedic, Inc.
2021-08-04	Z-2142-2021	Class II	ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only…	Remel Inc
2021-08-04	Z-2143-2021	Class II	CLARITI 1 DAY TORIC Power: -07	CooperVision Inc.
2021-08-04	Z-2144-2021	Class II	AQUATECH PLUS 1 DAY TORIC Power: -07	CooperVision Inc.
2021-08-04	Z-2145-2021	Class II	FRESH DAY 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2146-2021	Class II	CLARITI 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2147-2021	Class II	CLARITI 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2148-2021	Class II	SPECSAVERS UMERE TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2149-2021	Class II	CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07	CooperVision Inc.
2021-08-04	Z-2150-2021	Class II	CLARITI 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2151-2021	Class II	MEDIFLEX ELITE 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2152-2021	Class II	CLARITI 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2153-2021	Class II	FRESH DAY 1 DAY TORIC Power -07	CooperVision Inc.
2021-08-04	Z-2154-2021	Class II	SOFMED BREATHABLES 1 DAY TORIC Power-07	CooperVision Inc.
2021-08-04	Z-2155-2021	Class II	Proteus 235-Proton Therapy System	Ion Beam Applications S.A.
2021-08-04	Z-2156-2021	Class II	Affinity Four Birthing Bed-used as a birthing bed for women of child…	Hill-Rom, Inc.
2021-08-04	Z-2157-2021	Class II	Zippie Voyage	Sunrise Medical (US) LLC
2021-08-04	Z-2158-2021	Class II	Zippie Voyage	Sunrise Medical (US) LLC
2021-08-04	Z-2159-2021	Class II	Medtronic Vectris SureScan MRI	Medtronic Neuromodulation
2021-08-04	Z-2160-2021	Class II	OEC 3D Imaging	GE OEC Medical Systems, Inc
2021-08-04	Z-2161-2021	Class II	OEC Elite mobile C-arm	GE OEC Medical Systems, Inc
2021-08-04	Z-2162-2021	Class II	Coaxial Interventional Needle	INNOVATIVE TOMOGRAPHY PRODUCT GMBH
2021-08-04	Z-2163-2021	Class II	Coaxial Interventional Needle	INNOVATIVE TOMOGRAPHY PRODUCT GMBH
2021-08-04	Z-2164-2021	Class II	Semi-automatic Biopsy-Needle	INNOVATIVE TOMOGRAPHY PRODUCT GMBH
2021-08-04	Z-2166-2021	Class II	basixALPHA Inflation Device 30 atm/bar 20 mL	Merit Medical Systems, Inc.
2021-07-28	Z-2073-2021	Class I	Philips Respironics V60 Ventilator with Software Versions 3	Respironics California, LLC
2021-07-28	Z-2074-2021	Class I	Philips Respironics V60 Plus Ventilator with Software Versions 3	Respironics California, LLC
2021-07-28	Z-2080-2021	Class II	Cotton Rounds/Pads under the following brand names: 1	Medline Industries Inc
2021-07-28	Z-2081-2021	Class II	ANCILLARY ADULT 140-DOSE CONVENIENCE KIT	Mckesson Medical-Surgical Inc. Corporate Office
2021-07-28	Z-2082-2021	Class II	(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG…	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2083-2021	Class II	The Drain Bag Set	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2084-2021	Class II	Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are…	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2085-2021	Class II	026-20036A Liberty Drain Line	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2086-2021	Class II	Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid…	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2087-2021	Class II	NaturaLyte Dry Bicarbonate Concentrate is composed of sodium…	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2088-2021	Class II	The Fresenius APD Luer-Lock Adapter	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2089-2021	Class II	The MTS Set is a single-use	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2090-2021	Class II	050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use…	Fresenius Medical Care Holdings, Inc.
2021-07-28	Z-2091-2021	Class II	Disposable Replacement Backflush Brush Needles	Dutch Ophthalmic USA, Inc.
2021-07-28	Z-2092-2021	Class II	Hemotherm CE Dual Reservoir Cooler/Heater	Gentherm Medical, LLC
2021-07-28	Z-2093-2021	Class II	SoftGenomics version 4	Soft Computer Consultants, Inc.
2021-07-28	Z-2094-2021	Class II	Infant Heel Warmer with Attachment Tab	Cardinal Health 200, LLC
2021-07-28	Z-2095-2021	Class II	Infant Heel Warmer without Attachment Tab	Cardinal Health 200, LLC
2021-07-28	Z-2096-2021	Class II	AVSM3 SNF	Mediana Co., Ltd.
2021-07-28	Z-2097-2021	Class II	Illuminated Stepped Laser Probe Curved-for use in combination with…	Dutch Ophthalmic USA, Inc.
2021-07-28	Z-2098-2021	Class II	SoftCytogenetics	Soft Computer Consultants, Inc.
2021-07-28	Z-2099-2021	Class II	NEFA CAL	Randox Laboratories Ltd.
2021-07-28	Z-2100-2021	Class II	Cortoss Bone Augmentation Material 5cc Cartridge	Stryker Spine
2021-07-28	Z-2101-2021	Class II	Cortoss Bone Augmentation Material 10cc Cartridge	Stryker Spine
2021-07-28	Z-2102-2021	Class II	Medtronic Reveal LINQ LNQ11 / PA96000	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-07-28	Z-2103-2021	Class II	DJO Surgical EMPOWR 3D Knee Tibial Insert	Encore Medical, LP
2021-07-28	Z-2104-2021	Class II	DJO Surgical EMPOWR 3D Knee Tibial Insert	Encore Medical, LP
2021-07-28	Z-2105-2021	Class II	Cell Marque	Cell Marque Corporation
2021-07-28	Z-2106-2021	Class II	Cell Marque Antibodies	Cell Marque Corporation
2021-07-28	Z-2107-2021	Class II	Suture Anchor	Arthrex, Inc.
2021-07-28	Z-2108-2021	Class III	3AA battery cradle	Mindray DS USA, Inc. dba Mindray North America
2021-07-28	Z-2109-2021	Class II	Stimulen Collagen Moisturizing Lotion	Southwest Technologies Inc
2021-07-28	Z-2111-2021	Class II	Version: 1	Caption Health
2021-07-28	Z-2112-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2113-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2114-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2115-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2116-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2117-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2118-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2119-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2120-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2121-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2122-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2123-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2124-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2125-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2126-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2127-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2128-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2129-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2130-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2131-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2132-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-28	Z-2133-2021	Class II	Exactech Connexion GXL acetabular polyethylene liners used in the…	Exactech, Inc.
2021-07-21	Z-1956-2021	Class I	Trilogy 100	Philips Respironics, Inc.
2021-07-21	Z-1957-2021	Class I	A-Series BiPAP Hybrid A30	Philips Respironics, Inc.
2021-07-21	Z-1958-2021	Class I	A-Series BiPAP A 40	Philips Respironics, Inc.
2021-07-21	Z-1972-2021	Class I	Philips Respironics E30 with Humidifier	Philips Respironics, Inc.
2021-07-21	Z-1973-2021	Class I	DreamStation ASV	Philips Respironics, Inc.
2021-07-21	Z-1974-2021	Class I	SystemOne	Philips Respironics, Inc.
2021-07-21	Z-2015-2021	Class I	ADVANTIO DR EL	Boston Scientific Corporation
2021-07-21	Z-2016-2021	Class I	INGENIO DR EL	Boston Scientific Corporation
2021-07-21	Z-2017-2021	Class I	VITALIO DR EL	Boston Scientific Corporation
2021-07-21	Z-2018-2021	Class I	INVIVE CRT-P	Boston Scientific Corporation
2021-07-21	Z-2019-2021	Class I	INTUA CRT-P	Boston Scientific Corporation
2021-07-21	Z-2020-2021	Class I	INLIVEN CRT-P	Boston Scientific Corporation
2021-07-21	Z-2025-2021	Class II	Aequalis Ascend Flex Shoulder System Reversed Platform	Tornier, Inc
2021-07-21	Z-2044-2021	Class II	Toshiba Vantage Tiitan 1	Canon Medical System, USA, INC.
2021-07-21	Z-2045-2021	Class II	Canon Vantage Tiitan 1	Canon Medical System, USA, INC.
2021-07-21	Z-2046-2021	Class II	Canon Vantage Titan 3T	Canon Medical System, USA, INC.
2021-07-21	Z-2047-2021	Class II	Canon Vantage Galan 3T	Canon Medical System, USA, INC.
2021-07-21	Z-2048-2021	Class II	Hang&Go	RanD S.r.l.
2021-07-21	Z-2049-2021	Class II	Ch24 round silicone catheter	RanD S.r.l.
2021-07-21	Z-2050-2021	Class II	EcoFit cup cementless: Model	IMPLANTCAST GMBH
2021-07-21	Z-2051-2021	Class II	EASYGRIP FLO-41 US	Baxter Healthcare Corporation
2021-07-21	Z-2052-2021	Class II	SIGNA Premier	GE Healthcare, LLC
2021-07-21	Z-2053-2021	Class II	SIGNA Architect	GE Healthcare, LLC
2021-07-21	Z-2054-2021	Class II	SIGNA Pioneer	GE Healthcare, LLC
2021-07-21	Z-2055-2021	Class II	Discovery MR750w 3	GE Healthcare, LLC
2021-07-21	Z-2056-2021	Class II	Discovery MR750 3	GE Healthcare, LLC
2021-07-21	Z-2057-2021	Class II	SIGNA PET/MR	GE Healthcare, LLC
2021-07-21	Z-2058-2021	Class II	SIGNA Creator	GE Healthcare, LLC
2021-07-21	Z-2059-2021	Class II	SIGNA MR355	GE Healthcare, LLC
2021-07-21	Z-2060-2021	Class II	SIGNA MR380	GE Healthcare, LLC
2021-07-21	Z-2061-2021	Class II	SIGNA Artist	GE Healthcare, LLC
2021-07-21	Z-2062-2021	Class II	SIGNA Voyager	GE Healthcare, LLC
2021-07-21	Z-2063-2021	Class II	Optima MR450w 1	GE Healthcare, LLC
2021-07-21	Z-2064-2021	Class II	Discovery MR450 1	GE Healthcare, LLC
2021-07-21	Z-2065-2021	Class II	1	GE Healthcare, LLC
2021-07-21	Z-2066-2021	Class II	Lingen Disposable Virus Sampling Kit	Mercedes Medical, Inc.
2021-07-21	Z-2067-2021	Class II	Lingen SAMPLE Disposable Virus Sampling Kit pack	Mercedes Medical, Inc.
2021-07-21	Z-2068-2021	Class II	Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr	Arrow International Inc
2021-07-21	Z-2069-2021	Class II	Arrow Temporary Pacing Catheter/Introducer Kit 6Fr	Arrow International Inc
2021-07-21	Z-2070-2021	Class II	Arrow Bipolar Balloon Electrode Catheter 5 Fr	Arrow International Inc
2021-07-21	Z-2071-2021	Class II	Arrow Temporary Pacing Catheter/Introducer Kit 5Fr	Arrow International Inc
2021-07-21	Z-2072-2021	Class II	HeartWare	Heartware, Inc.
2021-07-21	Z-2075-2021	Class II	PC Application Software c4D as part of the device Catalyst: SP-002…	C-RAD POSITIONING AB

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