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U.S. Department of Health and Human Services

Medical Device Recalls

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Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model ... 2 02/17/2026 Medline Industries, LP
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY ... 2 02/17/2026 Medline Industries, LP
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010 2 01/23/2026 Cerapedics, Inc.
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20... 2 11/21/2025 Alcon Research LLC
Artegraft® Collagen Vascular Graft; REF: AG1015; 2 10/23/2025 LeMaitre Vascular, Inc.
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The... 2 10/10/2025 Iantrek Inc.
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-4... 1 10/10/2025 Cook Medical Incorporated
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG84... 2 10/08/2025 LeMaitre Vascular, Inc.
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060... 2 10/02/2025 W L Gore & Associates, Inc.
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (... 2 10/02/2025 LeMaitre Vascular, Inc.
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, M... 2 08/28/2025 American Contract Systems Inc
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmati... 2 03/26/2025 CooperVision, Inc.
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) ... 2 03/11/2025 Aesculap Inc
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version... 2 01/22/2025 Integrity Implants Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile 2 01/10/2025 Cook Biotech, Inc.
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and 2 01/10/2025 Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. 2 01/10/2025 Cook Biotech, Inc.
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-... 1 10/31/2024 DATEX--OHMEDA, INC.
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model... 1 10/31/2024 DATEX--OHMEDA, INC.
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 2 10/30/2024 Integra LifeSciences Corp.
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator 1 10/17/2024 DATEX--OHMEDA, INC.
GE Heathcare Giraffe OmniBed; neo natal incubator 1 10/17/2024 DATEX--OHMEDA, INC.
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft mater... 2 10/17/2024 Spineology, Inc.
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodia... 2 10/03/2024 Outset Medical, Inc.
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to rep... 2 09/25/2024 Cook Biotech, Inc.
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared h... 2 09/20/2024 Wipro GE Healthcare Private Ltd.
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an in... 2 09/17/2024 Innovasis, Inc
Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ ... 2 08/28/2024 MEDLINE INDUSTRIES, LP - Northfield
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellular... 2 08/08/2024 Artivion, Inc
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft... 2 08/08/2024 Artivion, Inc
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. 2 08/07/2024 LEICA BIOSYSTEMS NUSSLOCH GMBH
ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft 2 06/04/2024 Atrium Medical Corporation
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF... 1 06/03/2024 ARROW INTERNATIONAL Inc.
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are availab... 2 05/31/2024 Stryker Neurovascular
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diam... 2 05/31/2024 Stryker Neurovascular
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral veno... 2 05/15/2024 LeMaitre Vascular, Inc.
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for He... 2 05/03/2024 Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular... 2 05/03/2024 Angiodynamics, Inc.
DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access fo... 2 05/03/2024 Angiodynamics, Inc.
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access f... 2 05/03/2024 Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access fo... 2 05/03/2024 Angiodynamics, Inc.
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access fo... 2 05/03/2024 Angiodynamics, Inc.
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic su... 2 04/25/2024 Baxter Healthcare Corporation
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD i... 2 03/29/2024 Life Technologies Corporation
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and pati... 2 03/27/2024 Bolton Medical Inc.
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Re... 1 03/22/2024 Thoratec Corp.
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend ... 1 03/22/2024 Thoratec Corp.
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-2... 2 03/01/2024 Synthes (USA) Products LLC
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CA... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF S... 2 02/23/2024 Alphatec Spine, Inc.
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier 2 02/13/2024 Zimmer Surgical Inc
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) 2 02/09/2024 Musculoskeletal Transplant Foundation, Inc.
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) 2 02/09/2024 Musculoskeletal Transplant Foundation, Inc.
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized ... 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f)... 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix 2 10/25/2023 Medtronic Sofamor Danek USA Inc
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece whic... 2 10/06/2023 Zimmer Surgical Inc
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix... 2 09/08/2023 Medtronic Sofamor Danek USA Inc
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as gr... 2 08/28/2023 LeMaitre Vascular, Inc.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital ... 2 08/01/2023 Hamamatsu Corporation
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CH... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650... 2 07/06/2023 DATEX--OHMEDA, INC.
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M... 2 07/06/2023 DATEX--OHMEDA, INC.
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main... 2 06/06/2023 Bolton Medical Inc.
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-con... 2 04/07/2023 Outset Medical, Inc.
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 D... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DB... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S441... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5C... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15C... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON ... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCE... 2 04/04/2023 Medtronic Sofamor Danek USA Inc
Fusion Bioline Vascular Graft, Part number M00201503046B0 2 03/10/2023 Maquet Cardiovascular, LLC
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DE... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. O... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX 2 01/19/2023 Bolton Medical Inc.
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX 2 01/19/2023 Bolton Medical Inc.
Craftmatic Model 1 Base for Dual Bed Configurations 2 08/04/2022 Craftmatic Industries, Inc.
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autogr... 2 07/01/2022 DePuy Spine, Inc.
EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autogr... 2 07/01/2022 DePuy Spine, Inc.
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an e... 2 06/23/2022 Maquet Cardiovascular, LLC
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY 3 05/10/2022 Cerapedics, Inc.
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use... 2 03/07/2022 Maquet Cardiovascular, LLC
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System ... 2 02/18/2022 Medtronic Vascular, Inc.
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The... 1 02/15/2022 TELEFLEX MEDICAL INC
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-4550... 1 02/15/2022 TELEFLEX MEDICAL INC
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing ... 1 02/15/2022 TELEFLEX MEDICAL INC
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing c... 1 02/15/2022 TELEFLEX MEDICAL INC
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containin... 1 02/15/2022 TELEFLEX MEDICAL INC
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing... 1 02/15/2022 TELEFLEX MEDICAL INC
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing... 1 02/15/2022 TELEFLEX MEDICAL INC
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II B... 2 11/24/2021 Medtronic Vascular, Inc.
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE 2 11/24/2021 Medtronic Vascular, Inc.
Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS... 2 11/24/2021 Medtronic Vascular, Inc.
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-... 1 11/18/2021 Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-... 1 11/18/2021 Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-... 1 11/18/2021 Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-... 1 11/18/2021 Arrow International Inc
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for ... 2 09/29/2021 Atrium Medical Corporation
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax... 2 09/24/2021 Vascutek, Ltd.
CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general i... 2 09/22/2021 In2bones USA, LLC
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, ... 2 08/13/2021 W L Gore & Associates, Inc.
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, ... 2 08/13/2021 W L Gore & Associates, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG 1 08/06/2021 Heartware, Inc.
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF32... 2 07/23/2021 Medtronic Vascular, Inc.
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614... 2 07/23/2021 Medtronic Vascular, Inc.
PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft... 2 06/28/2021 SPINEART SA
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascul... 2 06/28/2021 Medtronic Vascular, Inc.
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are ... 2 06/01/2021 K2M, Inc
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are ... 2 06/01/2021 K2M, Inc
Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are in... 2 06/01/2021 K2M, Inc
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of b... 2 04/29/2021 Smith & Nephew, Inc.
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Prod... 2 04/20/2021 Medtronic Sofamor Danek USA, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Prod... 2 04/20/2021 Medtronic Sofamor Danek USA, Inc
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inser... 2 04/20/2021 Stryker Spine
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending th... 1 03/10/2021 Medtronic Vascular, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi... 2 01/12/2021 Roche Molecular Systems, Inc.
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: Th... 2 12/11/2020 Remote Diagnostic Technologies Ltd.
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 2 10/23/2020 W L Gore & Associates, Inc.
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System 2 10/23/2020 W L Gore & Associates, Inc.
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular tr... 2 09/12/2020 Cook Inc.
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts fo... 2 09/12/2020 Integra LifeSciences Corp.
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin ... 2 09/12/2020 Integra LifeSciences Corp.
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part... 2 09/12/2020 Integra LifeSciences Corp.
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are i... 2 07/10/2020 Cardinal Health 200, LLC
Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The syst... 2 07/10/2020 Cardinal Health 200, LLC
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for th... 2 07/10/2020 Cook Inc.
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. 2 06/15/2020 GE Healthcare, LLC
Giraffe Incubator with installed Servo Oxygen module. Infant incubator. 2 06/15/2020 GE Healthcare, LLC
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, T... 1 06/11/2020 Endologix, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 1 05/22/2020 Heartware, Inc.
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. 2 05/22/2020 GE Healthcare, LLC
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for e... 2 05/20/2020 W L Gore & Associates, Inc.
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm... 1 05/07/2020 Applied Medical Resources Corp
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Pro... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Prod... 2 05/04/2020 Maquet Cardiovascular, LLC
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M00202... 2 05/04/2020 Maquet Cardiovascular, LLC
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M00202... 2 05/04/2020 Maquet Cardiovascular, LLC
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M00202... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP... 2 05/04/2020 Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP... 2 05/04/2020 Maquet Cardiovascular, LLC
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 1... 2 04/29/2020 Allied Vision Group Inc
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm 2 03/20/2020 MEDTRONIC ATS MEDICAL, INC.
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 3591... 2 03/19/2020 XTANT MEDICAL INC
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC T... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC T... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC T... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC ... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC T... 1 02/14/2020 Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TR... 1 02/14/2020 Abbott Vascular
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. 2 01/31/2020 Cook Inc.
Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M122496... 2 01/31/2020 Lumitex Inc
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.... 2 12/30/2019 Medicrea International
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-00... 2 12/19/2019 Boston Scientific Corporation
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagno... 2 12/12/2019 Leica Microsystems, Inc.
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 1... 2 12/05/2019 Lens.com
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, M... 1 12/03/2019 GE Healthcare, LLC
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer 1 12/03/2019 GE Healthcare, LLC
Giraffe Incubator infant warmer 1 12/03/2019 GE Healthcare, LLC
Giraffe OmniBed infant warmer 1 12/03/2019 GE Healthcare, LLC
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indica... 2 11/08/2019 Smith & Nephew, Inc.
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a ... 2 11/04/2019 GE Healthcare, LLC
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant w... 2 10/04/2019 Ohmeda Medical
The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft ... 2 09/24/2019 GETINGE US SALES LLC
QuickGraft® Model # 430PST 2 09/20/2019 Musculoskeletal Transplant Foundation, Inc.
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, P... 2 08/22/2019 Thoratec Corp.
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner... 1 07/11/2019 GE Healthcare, LLC
RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended fo... 2 06/28/2019 Qiagen Sciences, Inc.
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22... 2 06/19/2019 Cook Inc.
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 2 05/29/2019 Exactech, Inc.
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 2 05/29/2019 Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 2 05/29/2019 Exactech, Inc.
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix i... 2 05/15/2019 Integra Limited
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control S... 2 05/14/2019 Opgen Inc
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, P... 2 04/30/2019 Molnlycke Health Care, Inc
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voi... 2 04/15/2019 Bioventus, LLC
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, ... 2 03/28/2019 ICU Medical, Inc.
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 ... 2 11/20/2018 Merck Millipore Ltd.
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded War... 2 11/19/2018 GE Healthcare, LLC
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: C... 2 11/19/2018 GE Healthcare, LLC
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Care... 2 11/19/2018 GE Healthcare, LLC
INFUSE Bone Graft X SMALL KIT REF 7510100 2 11/09/2018 Medtronic Sofamor Danek USA Inc
BioMend Extend, REF# 0142Z, Synthetic bone grafting material. 3 11/09/2018 Collagen Matrix, Inc.
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (I... 2 11/07/2018 Integrity Implants Inc.
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The... 2 10/24/2018 Terumo Cardiovascular Systems Corporation
CryoPatch SG Pulmonary Hemi-Artery, 1 graft 2 10/18/2018 CryoLife, Inc.
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS® ARIA 1M PEEK Spacer... 2 10/10/2018 Stryker Spine
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22... 1 10/03/2018 Endologix
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model ... 1 10/03/2018 Endologix
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Prox... 1 10/03/2018 Endologix
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: ... 1 10/03/2018 Endologix
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains c... 2 09/19/2018 Biocare Medical, LLC
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Nu... 2 09/11/2018 Cardiovascular Systems Inc
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C... 2 07/13/2018 AESDEX
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-... 2 07/11/2018 Anika Therapeutics, Inc.
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / ... 1 05/21/2018 Heartware
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Ca... 2 05/04/2018 Maquet Cardiopulmonary Ag
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft i... 2 04/20/2018 Ace Surgical Supply Co., Inc.
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosth... 2 04/19/2018 TMJ Solutions Inc
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: T... 2 04/10/2018 Neuropro Spinal Jaxx
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)1019030200607... 2 03/30/2018 Life Technologies Corporation
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an ... 2 03/26/2018 Ohmeda Medical
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within ... 2 03/15/2018 Zimmer Biomet, Inc.
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft t... 2 03/15/2018 Zimmer Biomet, Inc.
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specific... 2 03/01/2018 Howmedica Osteonics Corp.
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Deliver... 2 11/08/2017 Terumo BCT, Inc.
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO,... 2 09/27/2017 Medtronic Vascular, Inc.
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro ... 2 09/12/2017 Leica Biosystems Richmond Inc.
Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The a... 2 09/12/2017 Leica Biosystems Richmond Inc.
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro... 2 09/12/2017 Leica Biosystems Richmond Inc.
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagn... 2 09/12/2017 Leica Biosystems Richmond Inc.
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diag... 2 09/12/2017 Leica Biosystems Richmond Inc.
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro dia... 2 09/12/2017 Leica Biosystems Richmond Inc.
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replaceme... 2 09/06/2017 CryoLife, Inc.
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adher... 2 08/26/2017 Edwards Lifesciences, LLC
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicat... 1 08/10/2017 Cook Medical Incorporated
DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The La... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cor... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet C... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Lata... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarj... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fi... 2 06/06/2017 Alphatec Spine, Inc.
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). ... 2 05/30/2017 KCI USA, INC.
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' 2 05/03/2017 Molnlycke Health Care, Inc
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plasti... 2 04/27/2017 XTANT MEDICAL INC
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use... 1 04/27/2017 Heartware
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Numb... 2 04/10/2017 Cardiovascular Systems Inc
7F Prelude® Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4... 1 03/24/2017 Merit Medical Systems, Inc.
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. In... 2 03/20/2017 Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrar... 2 03/20/2017 Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Un... 2 03/20/2017 Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers... 2 03/20/2017 Ohmeda Medical
Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation dur... 2 03/20/2017 Ohmeda Medical
Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a contro... 2 03/20/2017 Ohmeda Medical
Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator... 2 03/20/2017 Ohmeda Medical
Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incub... 2 03/20/2017 Ohmeda Medical
Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy Syst... 2 03/20/2017 Ohmeda Medical
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ... 2 03/15/2017 Medtronic Vascular, Inc.
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage... 2 02/27/2017 Kiscomedica S.A.
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy Syste... 2 02/22/2017 Cardiovascular Systems Inc
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used t... 2 01/25/2017 Baxter Healthcare Corporation
Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used t... 2 01/25/2017 Baxter Healthcare Corporation
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent G... 2 01/19/2017 Endologix
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent ... 2 01/19/2017 Endologix
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. ... 2 01/18/2017 Smith & Nephew, Inc.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who w... 2 01/18/2017 Smith & Nephew, Inc.
AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent G... 2 01/18/2017 Endologix
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-1... 2 01/03/2017 Interventional Spine Inc
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS0... 2 12/22/2016 Amendia, Inc
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 ... 2 12/22/2016 Amendia, Inc
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-... 2 11/28/2016 Spectranetics Corporation
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 12... 2 11/28/2016 Spectranetics Corporation
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spina... 2 11/16/2016 Alphatec Spine, Inc.
TRANSPAC® IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO® FLUSHES, M... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE ... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO® FLUSH, MICRODRIP® (POLE MOU... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO® FLUSH AND MACRODRIP (POLE MOU... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO® FLUSH, MACRODRIP (PATIENT MOU... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO® FLUSH (INFUS... 2 11/15/2016 ICU Medical, Inc.
Transpac® IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo® Flush Device... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSAB... 2 11/15/2016 ICU Medical, Inc.
Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Tr... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO® FLUSHES, MAC... 2 11/15/2016 ICU Medical, Inc.
Transpac® IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo® Flush and Needleless Va... 2 11/15/2016 ICU Medical, Inc.
Transpac® IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo® Flush, Pall Air Filter, Mac... 2 11/15/2016 ICU Medical, Inc.
TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO® FLUSH, MACRODRIP (POLE MOUNT... 2 11/15/2016 ICU Medical, Inc.
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: Th... 1 11/09/2016 Micro Therapeutics Inc, Dba Ev3 Neurovascular
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac tr... 1 10/17/2016 Heartware, Inc.
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product:... 1 10/13/2016 HeartWare, Inc
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile... 2 09/20/2016 Smith & Nephew, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3... 2 09/15/2016 ICU Medical, Inc.
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 m... 2 09/15/2016 ICU Medical, Inc.
AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indica... 2 09/12/2016 Howmedica Osteonics Corp.
AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicate... 2 09/12/2016 Howmedica Osteonics Corp.
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicat... 2 09/12/2016 Howmedica Osteonics Corp.
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra® Dermal... 2 09/09/2016 Integra LifeSciences Corporation
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) T... 2 09/08/2016 NOVADAQ TECHNOLOGIES INC.
Zimmer® Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II hand... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside o... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside o... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged in... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a ... 2 08/04/2016 Zimmer Surgical Inc
Zimmer® Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is package... 2 08/04/2016 Zimmer Surgical Inc
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood produ... 2 07/22/2016 BEST THERATRONICS LTD.
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 ... 2 07/21/2016 Roche Molecular Systems, Inc.
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (... 1 07/08/2016 Heartware, Inc.
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER... 2 06/29/2016 Dako North America Inc.
SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part ... 2 06/17/2016 Cell Marque Corporation
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro dia... 3 06/10/2016 Leica Biosystems Richmond Inc.
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualit... 2 05/21/2016 Leica Microsystems, Inc.
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial ... 1 05/03/2016 B Braun Medical Inc
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for ... 1 05/03/2016 B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 20392... 1 05/03/2016 B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 ... 1 05/03/2016 B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >2... 1 05/03/2016 B Braun Medical Inc
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used fo... 1 05/03/2016 B Braun Medical Inc
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Numbe... 2 04/25/2016 Boston Scientific Corporation
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For I... 3 04/19/2016 Biocare Medical, LLC
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL S... 2 04/14/2016 Synthes (USA) Products LLC
Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration an... 3 04/04/2016 Richard-Allan Scientific Company
10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. ... 2 03/25/2016 Biomet Spine, LLC
ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as... 3 03/15/2016 Collagen Matrix Inc
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow® IAB is utilized for intra aortic ... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow® IAB is utilized for intra aortic ... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used ... 2 02/19/2016 Leica Microsystems, Inc.
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description  Carcinoembryoni... 3 02/17/2016 Lab Vision Corporation
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Prod... 2 02/13/2016 Exactech, Inc.
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for... 2 02/12/2016 Leica Microsystems, Inc.
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or s... 2 02/09/2016 Biomet France SARL
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or r... 2 02/09/2016 Bard Peripheral Vascular Inc
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or r... 2 02/09/2016 Bard Peripheral Vascular Inc
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnos... 2 11/25/2015 Leica Microsystems, Inc.
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; ... 3 11/20/2015 Lab Vision Corporation
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-... 2 11/19/2015 TZ Medical Inc.
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional suppo... 2 11/12/2015 Stryker Spine
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR ... 2 11/05/2015 Bard Peripheral Vascular Inc
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 ... 2 10/22/2015 Smith & Nephew, Inc., Endoscopy Div.
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardio... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardio... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiova... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiova... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Pro... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedur... 2 09/18/2015 Terumo Cardiovascular Systems Corp
Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH... 2 09/11/2015 Medivators, Inc.
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are design... 2 07/15/2015 Musculoskeletal Transplant Foundation, Inc.
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device inten... 2 06/26/2015 Vascutek, Ltd.
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device inten... 2 06/26/2015 Vascutek, Ltd.
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identificat... 3 06/26/2015 Roche Molecular Systems, Inc.
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vi... 3 05/26/2015 Biocare Medical, LLC
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II... 2 04/20/2015 Diasorin Inc.
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge... 2 04/07/2015 Bacterin International, Inc.
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) stai... 2 03/24/2015 Leica Microsystems, Inc.
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to... 1 02/25/2015 HeartWare Inc
The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005... 2 01/23/2015 Synthes, Inc.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI US... 2 01/07/2015 KCI USA, INC.
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be ... 2 01/05/2015 Spinal Elements, Inc
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Dril... 2 12/24/2014 Ebi, Llc
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage:... 2 12/16/2014 Biomet Spine LLC.
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pou... 2 11/14/2014 Edwards Lifesciences, LLC
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernata... 2 11/06/2014 Leica Microsystems, Inc.
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovati... 1 11/03/2014 Trivascular, Inc
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: F... 2 09/26/2014 Dako North America Inc.
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Numbe... 1 08/14/2014 Cardiovascular Systems, Inc.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. ... 2 06/25/2014 Integra LifeSciences Corp.
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Fin... 2 06/10/2014 Sakura Finetek USA Inc
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use... 2 05/14/2014 HeartWare Inc
Giraffe® Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who ar... 2 05/06/2014 GE Healthcare
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as... 2 05/06/2014 AlloSource, Inc.
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101,... 1 04/23/2014 HeartWare Inc
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannul... 2 04/16/2014 Edwards Lifesciences, LLC
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Sa... 2 03/26/2014 Trivascular, Inc
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) ... 1 03/21/2014 Thoratec Corporation
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine... 3 03/19/2014 Biomet 3i, LLC
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titaniu... 2 03/11/2014 Synthes, Inc.
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue ... 2 03/07/2014 Leica Biosystems Imaging, Inc.
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: Fo... 2 02/26/2014 Dako North America Inc.
GE Healthcare - Giraffe® and Panda® iRes Infant Warmer Product Usage: The infant radiant warme... 1 02/25/2014 GE Healthcare, LLC
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resus... 1 02/25/2014 GE Healthcare, LLC
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitat... 1 02/25/2014 GE Healthcare, LLC
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN sy... 2 02/20/2014 Synthes, Inc.
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic S... 2 02/12/2014 Medtronic Sofamor Danek USA Inc
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and ort... 2 02/07/2014 RTI Surgical, Inc.
Giraffe® Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road La... 2 02/03/2014 GE Healthcare
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gain... 2 02/03/2014 Exactech, Inc.
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is ... 2 01/22/2014 GE Healthcare, LLC
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab ... 2 01/16/2014 Lab Vision Corporation
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle ... 2 01/10/2014 Leica Biosystems Newcastle Ltd.
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are... 2 01/03/2014 RTI Surgical, Inc.
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Us... 1 12/17/2013 Nephros Inc
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive... 2 12/06/2013 Maquet Cardiovascular, LLC
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsi... 2 11/27/2013 Ebi, Llc
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver... 2 11/26/2013 Lanx, Inc.
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manuf... 2 11/21/2013 Stryker Spine
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnate... 2 11/18/2013 Terumo Cardiovascular Systems Corporation
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For ... 2 11/01/2013 Edwards Lifesciences, LLC
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, R... 2 11/01/2013 Edwards Lifesciences, LLC
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is ind... 2 10/31/2013 Globus Medical, Inc.
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Ca... 2 10/25/2013 Medtronic Vascular, Inc.
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery Sy... 2 10/17/2013 Harvest Technologies Corporation
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and... 2 09/30/2013 Atrium Medical Corporation
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, ... 2 09/30/2013 Atrium Medical Corporation
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial va... 2 09/30/2013 Atrium Medical Corporation
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and... 2 09/30/2013 Atrium Medical Corporation
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypas... 2 09/30/2013 Atrium Medical Corporation
Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass,... 2 09/30/2013 Atrium Medical Corporation
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and... 2 09/30/2013 Atrium Medical Corporation
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and ... 2 09/30/2013 Atrium Medical Corporation
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmen... 2 09/30/2013 Atrium Medical Corporation
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental b... 2 09/30/2013 Atrium Medical Corporation
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmenta... 2 09/30/2013 Atrium Medical Corporation
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmenta... 2 09/30/2013 Atrium Medical Corporation
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and... 2 09/30/2013 Atrium Medical Corporation
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET ... 2 09/25/2013 Maquet Cardiovascular Us Sales, Llc

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