BEUDAMED
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    VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code PPM·August 2, 2018

    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code IBG·August 2, 2018

    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code PPM·August 2, 2018

    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MVC·September 17, 2009

    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical Llc·Product code NJT·March 13, 2012

    EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    SPS Blue Line Tube Clamp Adapters, Product No. BL120M

    FDA Recall
    Terminated ·Southern Prosthetic Supply Co.·Product code ISH·October 3, 2006

    VSP Shock Module (as part of a prosthetic foot).

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISH·June 15, 2004

    VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.

    FDA Recall
    Terminated ·Applied Composite Technology·Product code ISH·June 20, 2007

    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

    FDA Recall
    Terminated ·Ossur Americas·Product code ISH·May 30, 2022

    Modular Knee Joint with Friction Brake

    FDA Recall
    Terminated ·Bock, Otto, Orthopedic Ind, Inc·Product code ISH·July 15, 2004

    Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007

    FDA Recall
    Terminated ·Ossur Grjothals 5 Reykjavik Ireland·Product code ISH·November 3, 2006

    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

    FDA Recall
    Terminated ·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISH·October 23, 2015

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISH·October 24, 2013

    Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.

    FDA Recall
    Terminated ·College Park Industries, Inc.·Product code ISH·April 5, 2012

    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.

    FDA Recall
    Terminated ·Ossur Americas, Inc.·Product code ISH·February 12, 2012

    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·March 4, 2015