BEUDAMED
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    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    BD K-3000 Microkeratome Blade REF 378607

    FDA Recall
    Terminated ·BD Opthalmic Systems·Product code HMY·January 24, 2003

    Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc, Tucson, AZ

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code KPA·September 29, 2006

    JUDKINS PACK

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code OEQ·February 11, 2021

    Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material 8886193662 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures Material 8886195332J Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures Material 8886196262 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures Material 8886191022 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·August 25, 2020

    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·September 23, 2020

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSA·May 10, 2019

    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code KPA·June 12, 2008

    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.

    FDA Enforcement
    Class II ·Terminated·Ventana Medical Systems Inc·September 4, 2013

    UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2" X 2" 8PL Y (6) GAUZE 4" X 4" 16PL Y (1) SYRINGE 1 cc TB SffiP (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP (1) SUTURE 3-0 BLK MONOFIL (1) TRAY ORGANIZER FULL DEEP (1) WRAPPER 30" X 30" L/F (1) PVP TRIPLE IODOPHOR SWABSTICK (1) TONGUE DEPRESSOR 6" WOOD (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP (1) SCALPEL WITH HANDLE #11 (1) MOSQUITO FORCEP STRAIGHT 5" (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) 3 PLY POLY TOWEL (1) UMBILICAL TAPE (1 ) PROBE GRONED & DISNEETNS 6" 2ML (1) EYE DRESSING EXT FINE POINT FULL (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO (1) PLASTIC TRAY 2/COMPARTMENT (1) HALF TRAY (1) STOPCOCK 3 WAY LUER SLIP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014

    Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BYD·December 3, 2015

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Recall
    Terminated ·AB ULAX Merkuriusgatan 8 Motala Sweden·Product code BYD·September 4, 2020