BEUDAMED
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    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 7, 2017

    GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·August 31, 2016

    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·April 22, 2020

    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·September 25, 2013

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013

    Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 24, 2013

    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013

    MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024

    Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 18, 2026

    Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH; g) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i) PEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j) PORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k) PORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l) PORT ACCESS PACK-LF, REF DYNJ0352159D; m) PORT DRESSING CHANGE KIT, REF DT22810; n) PORT DRESSING CHANGE TRAY, REF DT20640B; o) PORT DRESSING CHANGE TRAY, REF DYNDC3052A; p) PORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s) SALINE GAUZE DRESSING TRAY, REF DYNDA2937; t) SALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u) SALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v) ADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w) A-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x) CENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y) CENTRAL LINE DRESSING KIT, REF EBSI1088A; z) CENTRAL LINE DRESSING KIT, REF EBSI1088B; aa) CENTRAL LINE KIT, REF EBSI1245B; bb) CENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc) CVC DRESSING CHANGE KIT, REF EBSI1472A; dd) CVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee) CVL DRESSING CHANGE KIT, REF EBSI1547; ff) DIALYSIS CHANGE KIT, REF EBSI1453; gg) DIALYSIS KIT, REF EBSI1476; hh) DRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii) DRESSING CHANGE TRAY, REF EBSI1513; jj) EBSI DRESSING CHANGE KIT, REF EBSI1163B; kk) ERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll) ERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo) LARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp) OUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq) OUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr) PACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss) PICC DRESSING CHANGE KIT, REF EBSI1471A; tt) PICC DRESSING CHANGE TRAY, REF EBSI1512; uu) PICC DRESSING CHANGE TRAY, REF EBSI1546; vv) PICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww) PICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx) PORT ACCESS TRAY, REF DYNDC2703A; yy) PORT DRESSING CHANGE KIT, REF EBSI1434A; zz) PORT DRESSING CHANGE KIT, REF EBSI1525; aaa) PORT DRESSING CHANGE KIT, REF EBSI1525; bbb) PORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc) SMALL BORE DRESSING CHANGE KIT, REF EBSI1556

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024

    Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 18, 2026

    Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445; f) NICU INSERTION & DRSG CHG TRAY, REF EBSI1306A; g) PIV BSI KIT, REF BSIPIV1010; h) ULTRASOUND GUIDED IV START KIT, REF DYNDV2465

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024

    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

    FDA Enforcement
    Class II ·Terminated·GE Healthcare It·January 8, 2014

    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

    FDA Enforcement
    Class III ·Terminated·GE Healthcare It·February 5, 2014

    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

    FDA Enforcement
    Class II ·Terminated·GE Healthcare It·November 27, 2013

    Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Number DT19245; 6) BIOPSY KIT, Pack Number DYNDA1466A; 7) BIOPSY KIT, Pack Number DYNDA1466A; 8) CATH REMOVAL, Pack Number DYNDA1733B; 9) CATH REMOVAL, Pack Number DYNDA1814; 10) CATH REMOVAL, Pack Number DYNDA1814; 11) CATH REMOVAL, Pack Number DYNDA1814; 12) CATH REMOVAL, Pack Number DYNDA1814; 13) CATH REMOVAL, Pack Number DYNDA1814; 14) CATH REMOVAL, Pack Number DYNDA1814; 15) CATH REMOVAL, Pack Number DYNDA1814; 16) CATH REMOVAL, Pack Number DYNDA1814; 17) SHUNT TRAY, Pack Number DYNDA2725; 18) PORT ACCESS KIT, Pack Number DYNDC2945; 19) PORT ACCESS KIT, Pack Number DYNDC2945; 20) PORT ACCESS KIT, Pack Number DYNDC2945; 21) PORT ACCESS KIT, Pack Number DYNDC2945; 22) PORT ACCESS KIT, Pack Number DYNDC2945; 23) PORT ACCESS KIT, Pack Number DYNDC2945; 24) PORT ACCESS KIT, Pack Number DYNDC2945; 25) PORT ACCESS KIT, Pack Number DYNDC2945; 26) PORT ACCESS KIT, Pack Number DYNDC2945; 27) PORT ACCESS KIT, Pack Number DYNDC2945; 28) ARTHROGRAM TRAY, Pack Number DYNDH1113; 29) BIOPSY TRAY, Pack Number DYNDH1137C; 30) BIOPSY PACK, Pack Number DYNDH1248; 31) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 32) MYELOGRAM TRAY, Pack Number DYNDH1531; 33) BIOPSY PACK, Pack Number DYNDL1462B; 34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 36) PORT ACCESS TRAY, Pack Number EBSI1241; 37) PORT ACCESS TRAY, Pack Number EBSI1241; 38) PORT ACCESS TRAY, Pack Number EBSI1241; 39) PORT ACCESS TRAY, Pack Number EBSI1241; 40) PORT ACCESS TRAY, Pack Number EBSI1241; 41) PORT ACCESS TRAY, Pack Number EBSI1241; 42) PORT ACCESS TRAY, Pack Number EBSI1241; 43) PORT ACCESS TRAY, Pack Number EBSI1241; 44) PORT ACCESS TRAY, Pack Number EBSI1241; 45) PORT ACCESS TRAY, Pack Number EBSI1241; 46) PORT ACCESS TRAY, Pack Number EBSI1241; 47) PORT ACCESS TRAY, Pack Number EBSI1241; 48) PORT ACCESS TRAY, Pack Number EBSI1241; 49) PORT ACCESS TRAY, Pack Number EBSI1241; 50) PORT ACCESS TRAY, Pack Number EBSI1241; 51) PORT ACCESS TRAY, Pack Number EBSI1241; 52) PORT ACCESS TRAY, Pack Number EBSI1241; 53) PORT ACCESS TRAY, Pack Number EBSI1241; 54) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 55) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 58) OB DELIVERY TRAY, Pack Number MNS10875A; 59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 60) OB DELIVERY SET, Pack Number MNS3355; 61) LUMBAR TRAY, Pack Number SPEC0177; 62) 22G FACET TRAY, Pack Number SPEC0265A; 63) FINE LACERATION KIT, Pack Number SUT19360; 64) LACERATION TRAY, Pack Number SUT20955; 65) LACERATION TRAY, Pack Number SUT3780; 66) LACERATION TRAY, Pack Number SUT3780; 67) SUTURING SET, Pack Number SUT4020

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024