Medical device recalls reported in 2018

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Reported	Recall	Class	Product	Firm
2018-10-31	Z-0212-2019	Class II	APTIO 15000 REFRIGERATED STORAGE MODULE	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0213-2019	Class II	APTIO 9000 REFRIGERATED STORAGE MODULE	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0214-2019	Class II	APTIO RACK OUTPUT MODULE	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0215-2019	Class II	STREAMLAB CORE UNIT / LYNX WITH IOM	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0216-2019	Class II	STREAMLAB	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0217-2019	Class II	STREAMLAB	Siemens Healthcare Diagnostics, Inc.
2018-10-31	Z-0218-2019	Class II	NucliSENS¿ Magnetic Extraction Reagents	BioMerieux SA
2018-10-31	Z-0219-2019	Class II	Surgical Handpiece	Nakanishi Inc.
2018-10-31	Z-0220-2019	Class II	Surgical Handpiece	Nakanishi Inc.
2018-10-31	Z-0221-2019	Class II	Surgical Handpiece	Nakanishi Inc.
2018-10-31	Z-0222-2019	Class II	Surgical Handpiece	Nakanishi Inc.
2018-10-31	Z-0223-2019	Class II	Micro Surgery Handpiece SGS	Nakanishi Inc.
2018-10-31	Z-0224-2019	Class II	Micro Surgery Handpiece SGS	Nakanishi Inc.
2018-10-31	Z-0225-2019	Class II	Micro Surgery Handpiece SGA	Nakanishi Inc.
2018-10-31	Z-0226-2019	Class II	Micro Surgery Handpiece SGA	Nakanishi Inc.
2018-10-31	Z-0227-2019	Class II	VirtuoSaph Plus Endoscopic Vessel Harvesting System	Terumo Cardiovascular Systems Corporation
2018-10-31	Z-0228-2019	Class II	BACT/ALERT VIRTUO system	bioMerieux, Inc.
2018-10-31	Z-0229-2019	Class II	BACT/ALERT VIRTUO system	bioMerieux, Inc.
2018-10-31	Z-0230-2019	Class II	BACT/ALERT VIRTUO system	bioMerieux, Inc.
2018-10-31	Z-0231-2019	Class II	Instrument Arm Drape	Ecolab Inc
2018-10-31	Z-0232-2019	Class II	Camera Arm Drape	Ecolab Inc
2018-10-31	Z-0233-2019	Class II	Disposable Accessory Kit	Ecolab Inc
2018-10-31	Z-0234-2019	Class II	Disposable Accessory Kit	Ecolab Inc
2018-10-31	Z-0235-2019	Class II	Altrix¿ Precision Temperature Management System Model: 8001Product…	Stryker Medical Division of Stryker Corporation
2018-10-31	Z-0236-2019	Class II	SIGNA Architect system Product Usage: The Signa Architect system is a…	GE Medical Systems, LLC
2018-10-31	Z-0237-2019	Class II	Single-Use Biopsy Forceps	Micro-Tech (Nanjing) Co., Ltd.
2018-10-31	Z-0238-2019	Class II	3	Synthes (USA) Products LLC
2018-10-31	Z-0239-2019	Class II	Philips DigitalDiagnost software 4	Philips Medical Systems Gmbh, DMC
2018-10-31	Z-0240-2019	Class II	CHS Custom Convenience Kit-DR	Custom Healthcare Systems, Inc.
2018-10-31	Z-0241-2019	Class II	CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201	Custom Healthcare Systems, Inc.
2018-10-31	Z-0242-2019	Class II	CHS Custom Convenience Kit-	Custom Healthcare Systems, Inc.
2018-10-31	Z-0243-2019	Class II	CHS Custom Convenience Kit-COTTON TIP APPLICATORS	Custom Healthcare Systems, Inc.
2018-10-31	Z-0244-2019	Class II	CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS	Custom Healthcare Systems, Inc.
2018-10-31	Z-0245-2019	Class II	CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS)…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0246-2019	Class II	CHS Custom Convenience Kit-PAD	Custom Healthcare Systems, Inc.
2018-10-31	Z-0247-2019	Class II	CHS Custom Convenience Kit-TOOTHBRUSH	Custom Healthcare Systems, Inc.
2018-10-31	Z-0248-2019	Class II	CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0249-2019	Class II	(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0250-2019	Class II	CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0251-2019	Class II	CHS Custom Convenience Kit-LP NEEDLE	Custom Healthcare Systems, Inc.
2018-10-31	Z-0252-2019	Class II	CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0253-2019	Class II	CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number:	Custom Healthcare Systems, Inc.
2018-10-31	Z-0254-2019	Class II	CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number:…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0255-2019	Class II	CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520	Custom Healthcare Systems, Inc.
2018-10-31	Z-0256-2019	Class II	CHS Custom Convenience Kit-ROCHESTER PEAN	Custom Healthcare Systems, Inc.
2018-10-31	Z-0257-2019	Class II	CHS Custom Convenience Kit- COBAN¿	Custom Healthcare Systems, Inc.
2018-10-31	Z-0258-2019	Class II	CHS Custom Convenience Kit-FORMULA CAP	Custom Healthcare Systems, Inc.
2018-10-31	Z-0259-2019	Class II	CHS Custom Convenience Kit-SUTURE REMOVAL KIT	Custom Healthcare Systems, Inc.
2018-10-31	Z-0260-2019	Class II	CHS Custom Convenience Kit- PENROSE DRAIN	Custom Healthcare Systems, Inc.
2018-10-31	Z-0261-2019	Class II	CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000	Custom Healthcare Systems, Inc.
2018-10-31	Z-0262-2019	Class II	CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914	Custom Healthcare Systems, Inc.
2018-10-31	Z-0263-2019	Class II	CHS Custom Convenience Kit-TUBING W	Custom Healthcare Systems, Inc.
2018-10-31	Z-0264-2019	Class II	CHS Custom Convenience Kit-SURGICAL GOWN	Custom Healthcare Systems, Inc.
2018-10-31	Z-0265-2019	Class II	CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN	Custom Healthcare Systems, Inc.
2018-10-31	Z-0266-2019	Class II	CHS Custom Convenience	Custom Healthcare Systems, Inc.
2018-10-31	Z-0267-2019	Class II	CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number:…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0268-2019	Class II	CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part…	Custom Healthcare Systems, Inc.
2018-10-31	Z-0270-2019	Class III	Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup…	Ameditech Inc
2018-10-31	Z-0271-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0272-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0273-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0274-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0275-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0276-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0277-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0278-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0279-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0280-2019	Class II	O-arm 1000 2nd Edition Imaging System	Medtronic Navigation, Inc.-Littleton
2018-10-31	Z-0553-2016	Class II	GE Healthcare	GE Medical Systems, LLC
2018-10-24	Z-0102-2019	Class II	Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0103-2019	Class II	Thoratec CentriMag Motor	Thoratec Switzerland GMBH
2018-10-24	Z-0104-2019	Class II	Valeris Medical Apollo Medial Suture Anchor	Valeris Medical, LLC
2018-10-24	Z-0105-2019	Class II	Multirall	Liko AB
2018-10-24	Z-0106-2019	Class II	"Free and Total Protein S ELISA Kit" Cat	Helena Laboratories, Inc.
2018-10-24	Z-0107-2019	Class II	SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE	Baxter Healthcare Corporation
2018-10-24	Z-0108-2019	Class II	Carl Zeiss Meditec AG	Carl Zeiss Meditec AG
2018-10-24	Z-0109-2019	Class II	Ambu Aura40 Standard	Besmed Health Business Corporation
2018-10-24	Z-0110-2019	Class II	GE Healthcare MRI Systems	GE Medical Systems, LLC
2018-10-24	Z-0111-2019	Class II	GE Healthcare MRI Systems	GE Medical Systems, LLC
2018-10-24	Z-0112-2019	Class II	GE Healthcare MRI Systems	GE Medical Systems, LLC
2018-10-24	Z-0113-2019	Class II	ADVIA Centaur CKMB Calibrator	Siemens Healthcare Diagnostics, Inc
2018-10-24	Z-0114-2019	Class II	ADVIA Centaur CKMB Calibrator 2-pack Japan	Siemens Healthcare Diagnostics, Inc
2018-10-24	Z-0115-2019	Class II	ADVIA Centaur CKMB Master Curve Material	Siemens Healthcare Diagnostics, Inc
2018-10-24	Z-0116-2019	Class II	Atellica IM CKMB Calibrator	Siemens Healthcare Diagnostics, Inc
2018-10-24	Z-0117-2019	Class II	Atellica IM CKMB Master Curve Material	Siemens Healthcare Diagnostics, Inc
2018-10-24	Z-0118-2019	Class II	AS-OBGYN Information System version 7	AS Software, Inc.
2018-10-24	Z-0119-2019	Class II	McKesson Insulin Syringe 0	Cypress Medical Products LLC
2018-10-24	Z-0120-2019	Class II	Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer	A M Systems Inc
2018-10-24	Z-0121-2019	Class II	CryoPatch SG Pulmonary Hemi-Artery	CryoLife, Inc.
2018-10-24	Z-0122-2019	Class II	Affixus Hip Fracture Nail 125 9 mm x 180 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0123-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 260 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0124-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 300 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0125-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 320 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0126-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 340 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0127-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0128-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 380 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0129-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 440 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0130-2019	Class II	Affixus Hip Fracture Nail Right 125 9 mm x 460 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0131-2019	Class II	Affixus Hip Fracture Nail 125 11mm x 180mm	Zimmer Biomet, Inc.
2018-10-24	Z-0132-2019	Class II	Affixus Hip Fracture Nail Right 125 11 mm x 340 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0133-2019	Class II	Affixus Hip Fracture Nail Right 125 11 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0134-2019	Class II	Affixus Hip Fracture Nail Right 125 11 mm x 380 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0135-2019	Class II	Affixus Hip Fracture Nail Right 125 11 mm x 420 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0136-2019	Class II	Affixus Hip Fracture Nail Right 125 11 mm x 440 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0137-2019	Class II	Affixus Hip Fracture Nail Right 125 11 mm x 460 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0138-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 180 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0139-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 260 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0140-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 280 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0141-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 300 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0142-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0143-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 400 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0144-2019	Class II	Affixus Hip Fracture Nail Right 125 13 mm x 440 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0145-2019	Class II	Affixus Hip Fracture Nail Left 125 9 mm x 260 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0146-2019	Class II	Affixus Hip Fracture Nail Left 125 9 mm x 300 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0147-2019	Class II	Affixus Hip Fracture Nail Left 125 9 mm x 320 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0148-2019	Class II	Affixus Hip Fracture Nail Left 125 9 mm x 440 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0149-2019	Class II	Affixus Hip Fracture Nail Left 125 9 mm x 460 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0150-2019	Class II	Affixus Hip Fracture Nail Left 125 11 mm x 260 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0151-2019	Class II	Affixus Hip Fracture Nail Left 125 11 mm x 320 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0152-2019	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-10-24	Z-0153-2019	Class II	Affixus Hip Fracture Nail Left 125 11 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0154-2019	Class II	Affixus Hip Fracture Nail Left 125 13 mm x 260 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0155-2019	Class II	Affixus Hip Fracture Nail Left 125 13 mm x 340 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0156-2019	Class II	Affixus Hip Fracture Nail Left 125 13 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0157-2019	Class II	Affixus Hip Fracture Nail Right 130 9 mm x 320 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0158-2019	Class II	Affixus Hip Fracture Nail 130 11 mm x 180 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0159-2019	Class II	Affixus Hip Fracture Nail Right 130 11 mm x 320 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0160-2019	Class II	Affixus Hip Fracture Nail Right 130 11 mm x 340 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0161-2019	Class II	Affixus Hip Fracture Nail Right 130 11 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0162-2019	Class II	Affixus Hip Fracture Nail Right 130 11 mm x 400 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0163-2019	Class II	Affixus Hip Fracture Nail Right 130 13 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0164-2019	Class II	Affixus Hip Fracture Nail Left 130 9 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0165-2019	Class II	Affixus Hip Fracture Nail Left 130 11 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0166-2019	Class II	Affixus Hip Fracture Nail Left 130 11 mm x 380 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0167-2019	Class II	Affixus Hip Fracture Nail Left 130 11 mm x 400 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0168-2019	Class II	Affixus Hip Fracture Nail Left 130 15 mm x 360 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0169-2019	Class II	Affixus Hip Fracture Nail 125 9 mm x 165 mm	Zimmer Biomet, Inc.
2018-10-24	Z-0170-2019	Class II	Mindray BeneVision Distributed Monitoring System	Mindray DS USA, Inc. dba Mindray North America
2018-10-24	Z-0171-2019	Class II	Gibco MEM Non-Essential Amino Acids Solution	Life Technologies, Corp.
2018-10-24	Z-0172-2019	Class II	Gibco DPBS	Life Technologies, Corp.
2018-10-24	Z-0173-2019	Class II	Gibco Sodium Pyruvate	Life Technologies, Corp.
2018-10-24	Z-0174-2019	Class II	Gibco GlutaMAX Supplement	Life Technologies, Corp.
2018-10-24	Z-0175-2019	Class II	Philips HeartStart FR3 Defibrillator	Philips Electronics North America Corp.
2018-10-24	Z-0176-2019	Class II	Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System	Terumo Cardiovascular Systems Corporation
2018-10-24	Z-0177-2019	Class II	Biograph Horizon a) 3R	Siemens Medical Solutions USA, Inc.
2018-10-24	Z-0178-2019	Class II	Biograph mCT: a) S	Siemens Medical Solutions USA, Inc.
2018-10-24	Z-0179-2019	Class II	Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0180-2019	Class II	Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0181-2019	Class II	Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0182-2019	Class II	Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0183-2019	Class II	ECMO Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0184-2019	Class II	Reinforced Dual Lumen Cannula	OriGen Biomedical, Inc.
2018-10-24	Z-0189-2019	Class II	Atellica Sample Handler Prime	Siemens Healthcare Diagnostics, Inc.
2018-10-24	Z-0190-2019	Class II	Atellica Sample Handler Connect	Siemens Healthcare Diagnostics, Inc.
2018-10-24	Z-0191-2019	Class II	Atellica Sample Handler Additional	Siemens Healthcare Diagnostics, Inc.
2018-10-24	Z-0192-2019	Class II	Atellica IM 1300 Analyzer	Siemens Healthcare Diagnostics, Inc.
2018-10-24	Z-0193-2019	Class II	Atellica IM 1600 Analyzer	Siemens Healthcare Diagnostics, Inc.
2018-10-24	Z-0194-2019	Class II	Atellica CH 930 Analyzer	Siemens Healthcare Diagnostics, Inc.
2018-10-24	Z-0195-2019	Class II	Centricity Universal Viewer with Cross Enterprise Display This…	GE Healthcare, LLC
2018-10-17	Z-0076-2019	Class II	BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F…	Angiodynamics Inc. (Navilyst Medical Inc.)
2018-10-17	Z-0077-2019	Class II	Hemosll ReadiPlasTin	Instrumentation Laboratory Co.
2018-10-17	Z-0078-2019	Class II	INSORB SUBCUTICULAR SKIN STAPLER	Incisive Surgical Inc
2018-10-17	Z-0079-2019	Class II	VITROS 5600 Integrated System-For use in the in vitro quantitative	Ortho-Clinical Diagnostics
2018-10-17	Z-0080-2019	Class II	VITROS 5600 Integrated System-	Ortho-Clinical Diagnostics
2018-10-17	Z-0081-2019	Class III	BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station	Becton Dickinson & Co.
2018-10-17	Z-0082-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left	Orthosensor, Inc.
2018-10-17	Z-0083-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right	Orthosensor, Inc.
2018-10-17	Z-0084-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left	Orthosensor, Inc.
2018-10-17	Z-0085-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right	Orthosensor, Inc.
2018-10-17	Z-0086-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left	Orthosensor, Inc.
2018-10-17	Z-0087-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right	Orthosensor, Inc.
2018-10-17	Z-0088-2019	Class II	Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine	MEDLINE INDUSTRIES INC
2018-10-17	Z-0089-2019	Class II	Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile	Implant Direct Sybron Manufacturing, LLC
2018-10-17	Z-0090-2019	Class II	Reprocessed Agilis Steerable Introducer: indicated for introducing…	Sterilmed, Inc.
2018-10-17	Z-0091-2019	Class II	Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene…	Reckitt Benckiser LLC
2018-10-17	Z-0092-2019	Class II	AVS Aria Cage	Stryker Spine
2018-10-17	Z-0093-2019	Class II	NeoMed Enteral Feeding Tubes with Enteral Only Connectors	Neomed Inc
2018-10-17	Z-0094-2019	Class II	Widex BABY hearing aid	Widex A/S
2018-10-17	Z-0095-2019	Class II	GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of…	GE Healthcare Finland Oy
2018-10-17	Z-0096-2019	Class II	GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of…	GE Healthcare Finland Oy
2018-10-17	Z-0097-2019	Class II	Codan Filter	Bayer Medical Care, Inc.
2018-10-17	Z-0098-2019	Class II	Colpo-Pneumo Occluder	CooperSurgical, Inc.
2018-10-17	Z-0101-2019	Class II	Enterprise Imaging Desktops Enterprise Imaging Desktops	Agfa Healthcare NV
2018-10-10	Z-0001-2019	Class II	Journey BCS Knee CoCr Femoral Components	Smith & Nephew, Inc.
2018-10-10	Z-0002-2019	Class II	JOURNEY BCS OXINIUM Knee Femoral Components	Smith & Nephew, Inc.
2018-10-10	Z-0003-2019	Class II	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111	Smith & Nephew, Inc.
2018-10-10	Z-0004-2019	Class II	TrueBeam Radiotherapy Delivery System version 2	Varian Medical Systems
2018-10-10	Z-0005-2019	Class II	VitalBeam Radiotherapy Delivery System Version 2	Varian Medical Systems
2018-10-10	Z-0006-2019	Class I	ENDOLOGIX AFX Endovascular AAA System	Endologix
2018-10-10	Z-0007-2019	Class I	ENDOLOGIX AFX2 Bifurcated Endograft System	Endologix
2018-10-10	Z-0008-2019	Class I	ENDOLOGIX AFX/AFX2	Endologix
2018-10-10	Z-0009-2019	Class I	ENDOLOGIX AFX/AFX2	Endologix
2018-10-10	Z-0010-2019	Class II	ABL90 FLEX analyzers with software versions 3	Radiometer America Inc
2018-10-10	Z-0011-2019	Class II	ellex I	Ellex iScience, Inc.
2018-10-10	Z-0012-2019	Class II	Equinoxe Reverse Drill Bit Kit	Exactech, Inc.
2018-10-10	Z-0013-2019	Class II	Kerlix AMD Antimicrobial Bandage Roll	COVIDIEN LLC
2018-10-10	Z-0014-2019	Class II	Kerlix Bandage Roll	COVIDIEN LLC
2018-10-10	Z-0015-2019	Class II	Kerlix Gauze Roll	COVIDIEN LLC
2018-10-10	Z-0016-2019	Class II	Kerlix Bandage Roll	COVIDIEN LLC
2018-10-10	Z-0017-2019	Class II	Dermacea Gauze Fluff Roll	COVIDIEN LLC

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