BEUDAMED
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    FED RINGED-TEX VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Shanghai Beijin

    FDA UDI
    Shanghai Beijin Biotechnological Co., LTD·06975756090022·EDEN FED MEDIUM B

    Shanghai Beijin

    FDA UDI
    Shanghai Beijin Biotechnological Co., LTD·06975756090015·EDEN FED MEDIUM A

    FED

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code FED·March 18, 2016

    IN-FED

    FDA Adverse Event
    Death ·SCHEIN PHARMACEUTICAL·June 20, 1994

    Howsport

    FDA UDI
    JIAXING HOW SPORT MEDICAL INSTRUMENT CO., LTD.·06975380616049·

    GRAVITY FED BALLOON INFUSION DEVICE

    FDA Adverse Event
    Malfunction ·Product code MBE·December 1, 2022

    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

    FDA Enforcement
    Class I ·Terminated·Atossa Genetics, Inc.·November 6, 2013

    GRAVITY-FED BAG SET, 1200ML, WITH ENFIT CONNECTOR

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code PIO·March 11, 2016

    GRAVITY-FED BAG SET, 500ML, WITH ENFIT CONNECTOR

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code PIO·March 14, 2016

    TERUMO T 220 DIALYZER - USE #4 & #5

    FDA Adverse Event
    Injury ·TERUMO CORP.·Product code FJI·December 2, 1994

    KARL STORZ

    FDA Adverse Event
    Other ·KARL STORZ GMBH & CO. KG·Product code KOG·October 6, 2010

    LIGACLIP**

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 7, 2014

    LIGACLIP**

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 7, 2014

    LIGAMAX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 10, 2014

    LIGAMAX ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 16, 2015

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 25, 2010

    FLEXIFLO COMPANION ENTERAL NUTRITION PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIV ABBOTT LABORATORIES·Product code LZH·December 3, 1998

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 25, 2014