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    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019

    Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LLZ·February 14, 2017

    Odyssey Intended use: Radiation treatment planning system

    FDA Recall
    Terminated ·PerMedics, Inc.·Product code MUJ·March 23, 2010

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019

    ITW Dymon Medaphene Plus Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 34720. The firm name on the label is ITW Dymon, Olathe, KS. The product is also sold under the following private labels: (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    ITW Dymon Medaphene Plus Orange Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 52920. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) O.D.S. Orange Disinfectant Spray, Continental Research Corporation, St. Louis, MO; (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation, Vernon Hills, IL; (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies, Tulsa, OK, Newburgh, IN, and Hopkinsville, KY; (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products, Cleveland, OH; (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply, Cape Girardeau, MO; (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries, Conway, AR; (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc., Norwood, MA; (8) Meyer Tri Power, Sold By Meyer Laboratory Inc., Blue Springs, MO; (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc., Irving, TX; (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company, St. Louis, MO; (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc., Alpharetta, GA; (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc., Elmhurst, IL; (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Phoenix, AZ.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    ITW Dymon Medaphene Plus Country Garden Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #42620. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL; (2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL; (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC; (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA; (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO; (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH; (8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI; (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL; (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY; (12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO; (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY; (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO; (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR; (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL; (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ; (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV; (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL. One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.

    FDA Recall
    Terminated ·ITW Dymon·February 15, 2005

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·July 30, 2014

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·November 13, 2013

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code JPA·June 20, 2014

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code JCA·August 22, 2013

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013

    HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.

    FDA Recall
    Terminated ·ITC-Nexus Dx, Inc.·Product code GKR·January 21, 2011

    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy

    FDA Enforcement
    Class II ·Terminated·TZ Medical, Inc.·November 2, 2016

    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·September 14, 2016

    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·January 22, 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·January 8, 2014

    Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·January 22, 2014